KERALA MEDICAL SERVICES CORPORATION LTD.kmscl.kerala.gov.in/media/qcmanual.pdf · KERALA MEDICAL...
Transcript of KERALA MEDICAL SERVICES CORPORATION LTD.kmscl.kerala.gov.in/media/qcmanual.pdf · KERALA MEDICAL...
PREFACE
Kerala Medical Services Corporation has been designated as the central procurement agency in place of the erstwhile Central Purchase Committee for procurement of drugs and is operational with effect from 1st April 2008. Government has later entrusted the centralized procurement of equipments also with KMSCL. The Corporation has procured drugs worth Rs.150.17 crores in 2008-09, Rs.147.29 crores in 2009-10 and Rs. 44.49 crores in 2010-11. The procurement cost of equipments is estimated as Rs. 41 crores. The Quality Control policy of Kerala Medical Services Corporation has been defined by the Managing Director as appropriate to the long term vision, commitment to quality, people’s perception of KMSCL procured items and other aspects of Health and Family welfare. In order to assure that the best possible medicines and other medical supplies to be made available to the consumers, it is imperative that it fulfills the following parameters 1) Right quality 2) Right quantity and 3) Right price For assuring the safety and efficacy of various drugs and supplies that are made available by KMSCL, this Quality Control Manual has been introduced. All procedures, instructions, and directions set forth in this manual are in accordance with and confirm to the requirement of standards like IP, BP, USP, BPC, NF, IS ,ISO and as per the KMSCL`S specifications. The manual shall provide in-depth understanding of the need of quality system, including prescribing the tests required to be conducted for the drugs and supplies procured by the KMSCL. And moreover this document will also be a part of the tender document. The manual will be revised as needed to incorporate improvements so as to strengthen the quality control parameters.
Sd/- BIJU PRABHAKAR.IAS MANAGING DIRECTOR
KKEERRAALLAA MMEEDDIICCAALL SSEERRVVIICCEESS CCOORRPPOORRAATTIIOONN LLTTDD QUALITY CONTROL MANUAL FOR DRUGS AND SUPPLIES
Title : Current Index For Drugs and Supplies Page 1 of 13
Sl. No. Drug Name Drug Code Page No.
TABLETS 1
1 Acetyl Salicylic acid Tablets I.P D01018&D13024 2
2 Acyclovir Tablets IP D09002 3
3 Albendazole Tablets IP D08001 4
4 Allopurinol Tablets I.P D01013 5
5 Alprazolam Tablets IP D17007 6
6 Aluminium Hydroxide Tablets IP D20003 7
7 Amitriptyline Tablets IP D17005 8
8 Amlodipine Tablets IP D13012&D13031 9
9 Amoxycillin Dispersible Tablets I.P D02003 10
10 Atenolol Tablets IP D13008 11
11 Atorvastatin Tablets IP D13013 12
12 Azithromycin Tablets D02031 13
13 Bisacodyl Tablets IP D20012 14
14 Calcium lactate Tablets IP D22001 15
15 Carbamazepine Tablets IP D07005 16
16 Carbidopa+Levodopa Tablets IP D11002 17
17 Cetirizine Tablets 18
18 Chlordiazepoxide Tablets IP D17009 19
19 Chloroquine phosphate Tablets IP D08009 20
20 Chlorpheneramine maleate Tablets IP D05006 21
21 Chlorpromazine Tablets IP D17002&D17003 22
22 Ciprofloxacin Tablets I.P D02011 23
23 Clobazam Tablets D07009 24
24 Clomiphene citrate Tablets D16009 25
25 Clopidogrel Tablets IP D13023 26
26 Clotrimazole vaginal Tablets IP D08008 27
27 Clozapine Tablets D17014&D17015 28
28 Co-trimoxazole Tablets I.P D02001 29
KKEERRAALLAA MMEEDDIICCAALL SSEERRVVIICCEESS CCOORRPPOORRAATTIIOONN LLTTDD QUALITY CONTROL MANUAL FOR DRUGS AND SUPPLIES
Title : Current Index For Drugs and Supplies Page 2 of 13
29 Dexamethasone Tablets IP D05003 30
30 Diazepam Tablets IP D17001 31 Sl. No.
Drug Name Drug Code Page No.
31 Diclofenac sodium Tablets I.P D01004 32
32 Dicyclomine Hcl Tablets IP D20008 33
33 Diethyl carbamazine Tablets IP D08003 34
34 Digoxin Tablets IP D13014 35
35 Diltiazem Tablets IP D13004 36
36 Domperidone Tablets IP D200007 37
37 Enalapril Maleate Tablets IP D13009D13032 38
38 Erythromycin stearate Tablets I.P D02015 39
39 Ferrous sulphate Tablets D22006 40
40 Fluconozole Tablets D08014 41
41 Folic acid Tablets IP D12002 42
42 Frusemide Tablets IP D19001 43
43 Glibenclamide Tablets IP D21001&D21002 44
44 Glipizide Tablets D21004 45
45 Griseofulvin Tablets IP D08005 46
46 HaloperidolTablets IP D17010 47
47 Ibuprofen Tablets I.P(Film coated) D01006 48
48 Imipramine Tablets IP D17004 49
49 Isosorbide dinitrate Tablets IP D13001&D13002 50
50 Isosorbide-5 mononitrate Tablets IP D13003 51
51 Ketoconozole Tablets IP D08006 52
52 Lithium carbonate Tablets IP D17025&D17026 53
53 Lorazepam D17033 54
54 Losartan potassium D13011 55
55 Mefanamic Acid Tablets I.P D01014 56
56 Metformin Tablets IP D21003 57
57 Methylergometrin maleate Tablets IP D16003 58
58 Metoclopramide Tablets IP D200006 59
KKEERRAALLAA MMEEDDIICCAALL SSEERRVVIICCEESS CCOORRPPOORRAATTIIOONN LLTTDD QUALITY CONTROL MANUAL FOR DRUGS AND SUPPLIES
Title : Current Index For Drugs and Supplies Page 3 of 13
59 Metoprolol Tablets IP D13020D13033 60
60 Metronidazole Tablets I.P D02023 61
61 Nicotinic acid Tablets IP D13021 62
Sl. No.
Drug Name Drug Code Page No.
62 Nifedipine Tablets IP D13005 63
63 Nitrazepam Tablets IP D17006 64
64 Norfloxacin Tablets I.P D02016 65
65 Ofloxacin Tablets D02017 66
66 Olanzapine Tablets D17016&D17020 67
67 Paracetamol Tablets I.P D01002 68
68 Pheneramine maleate Tablets IP D05007 69
69 Phenobarbitone Tablets IP D07002 70
70 Phenytoin sodium Tablets IP D07004 71
71 Prednisolone Tablets IP D05011 72
72 Proponolol Tablets IP D13029&D13030 73
73 Ranitidine Tablets IP D20002 74
74 Risperidone Tablets D17017 75
75 Salbutamol sulphate Tablets IP D03004 76
76 SertalineTablets D17019 77
77 Sodium valproate Tablets IP D07006&D07010 78
78 Spiranolactone Tablets IP D19003&D19004 79
79 Sulfasalazine Tablets B.P D01015 80
80 Tamoxifen Tablets IP D24027 81
81 Theophylline and Etophylline Tablets D03002 82
82 Thyroxine Tablets IP D21019 83
83 Tramadol Tablets I.P D01012 84
84 Trihexyphenidyl Tablets IP D11001 85
85 Verapamil Tablets IP D13007 86
86 Vitamin B complex Tablets NFI(strong) D22002&D22004 87
CAPSULES 88
87 Amoxycillin Capsules IP D02004&D02005 89
KKEERRAALLAA MMEEDDIICCAALL SSEERRVVIICCEESS CCOORRPPOORRAATTIIOONN LLTTDD QUALITY CONTROL MANUAL FOR DRUGS AND SUPPLIES
Title : Current Index For Drugs and Supplies Page 4 of 13
88 Ampicillin Capsules IP D02007 90
89 Clofazimine Capsules IP D10002 91
90 Cloxacillin Capsules IP D02006 92
91 Doxycycline Capsules IP D02014 93
Sl. No.
Drug Name Drug Code Page No.
92 Fluoxetine Capsules D17008 94
93 Hydroxy urea Capsules USP D24023 95
94 Nifedipine soft gelatin Capsules D13006 96
95 Omeprazole Capsules D20004 97
96 Vitamin A & D soft gelatin Capsules D22005 98
ORAL LIQUIDS, SOLUTIONS AND POWDERS 99
97 Amoxycillin dry syrup IP D2032&D02033 100
98 Benedicts Reagent D26001 101
99 Cephalexin oral suspension(dry) IP D02022 102
100 Chlorhexidine with Ethyl alcohol solution D25010 103
101 Chlorhexidine/Cetrimide solution D25001 104
102 Chloroxylenol solution BP D250057D25006 105
103 Cotrimoxazole Oral suspension IP D02002 106
104 Dicyclomine oral solution IP D20010 107
105 Diethyl carbamazine citrate suspension D08004 108
106 Formaldehyde solution D25014 109
107 Gamma benzene hexachloride solution USP D14010 110
108 Gluteraldehyde solution BP D25007 111
109 Glycerin IP D14021 112
110 Halothane USP liquid D04002 113
111 Hydrogen peroxide solution IP D25003&D25016 114
112 Mixture carminative concentrate D20013 115
113 Non oxylenol surfactant based Iodine Solution D25009 116
114 ORS powder IP D20011 117
115 Orthothaladehyde solution D25008 118
116 Paracetamol syrup D01003 119
KKEERRAALLAA MMEEDDIICCAALL SSEERRVVIICCEESS CCOORRPPOORRAATTIIOONN LLTTDD QUALITY CONTROL MANUAL FOR DRUGS AND SUPPLIES
Title : Current Index For Drugs and Supplies Page 5 of 13
117 Piperazine citrate syrup IP D08016 120
118 Povidone-Iodine solution IP D14011&D14019 121
119 Salbutamol Nebuliser solution BP D03006 122
120 Salbutamol syrup IP D03005 123
121 Syrup Lactulose USP D20015 124
Sl. No.
Drug Name Drug Code Page No.
GELS, CREAMS, OINTMENTS, LINIMENTS, LOTIONS, PESSERIES
125
122 Acyclovir cream BP D09003 126
123 Benzyl benzoate application IP D14006 127
124 Betamethasone valerate cream USP D14009 128
125 Calamine lotion IP D14014 129
126 Chloramphenicol Applicaps D15010 130
127 Ciprofloxacin eye ointment USP D15003 131
128 Clotrimazole cream IP D08007 132
129 Glycerin magsulf BPC D14007 133
130 Lignocaine Hcl gel IP D04003 134
131 Povidone-Iodine ointment USP D14008 135
132 Povidone-Iodine vaginal pesseries D16006 136
133 Salicylic acid ointment BP D14004 137
134 Silversulphadiazine cream USP D14001 138
135 Turpentine liniment IP D14013 139
136 Whitfields ointment IP D14005 140
EAR DROPS / EYE DROPS 141
137 Betamethasone Eye drops IP D15007 142
138 Ciprofloxacin Eye/Ear drops IP D15002 143
139 Timolol maleate eye drops IP D15005 144
140 Tropicamide eye drops IP D15006 145
141 Saline nasal drops D15011 146
142 Sodium bicarbonate ear drops BPC D15008 147
143 Xylometazoline Nasal drops IP D15009 148
PARENTERALS 149
KKEERRAALLAA MMEEDDIICCAALL SSEERRVVIICCEESS CCOORRPPOORRAATTIIOONN LLTTDD QUALITY CONTROL MANUAL FOR DRUGS AND SUPPLIES
Title : Current Index For Drugs and Supplies Page 6 of 13
144 Aciclovir Injection IP D09001 150
145 Adrenaline bitartrate Injection IP D05005 151
146 Amikasin Sulphate Injection IP D02021 152
147 Aminophylline Injection IP D03003 153
148 Anti Snake venom(Freeze dried) D21012 154
149 Ampicillin Injection IP D02008 155 Sl. No.
Drug Name Drug Code Page No.
150 Atropine Injection IP D04007 156
151 Benzyl Penicillin Injection IP D02009 157
152 Betamethasone sodium Injection IP D05004 158
153 Bleomycin Injection IP D24009 159
154 Bupivacaine HCl in Dextrose injection USP D04017 160
155 Calcium Gluconate Injection IP D22003 161
156 Carboprost Injection IP D06008 162
157 Cefotaxime Injection IP D02026 163
158 Cefotaxime Sodium Injection IP D02010 164
159 Cefuroxime Injection IP D02019 165
160 Chlorpheniramine maleate Injection IP D05008 166
161 Ciprofloxacin Injection IP D02012 167
162 Cisplastin Injection IP D24012&D24013 168
163 Cloxacillin Injection IP D02025 169
164 Cyclophosphamide Injection IP D24003&D24004 170
165 Cynocobalamin Injection IP D12001 171
166 Cytosine Arabinoside Injection IP D24021 172
167 Desferrioxamine Injection BP D06006 173
168 Dexamethasone sodium Injection IP D05001 174
169 Dextran 40 with Sodiumchloride 0.9% IP D12007 175
170 Dextrose Injection IP D18003, D18004, D18005, D18006
176
171 Diazepam Injection IP D07007 177
172 Diclofenac sodium Injection IP D01005 178
173 Dicyclomine Hcl Injection IP D20009 179
KKEERRAALLAA MMEEDDIICCAALL SSEERRVVIICCEESS CCOORRPPOORRAATTIIOONN LLTTDD QUALITY CONTROL MANUAL FOR DRUGS AND SUPPLIES
Title : Current Index For Drugs and Supplies Page 7 of 13
174 Digoxin Injection IP D13015 180
175 Dimercaprol Injection IP D06009 181
176 Dobutamine Hydrochloride Injection USP D13017 182
177 Dopamine Hydrochloride Injection USP D13016 183
178 Doxurubicin Hcl Injection IP D24024 184
179 Electrolyte M Injection (Maintenance)
D18008 185
180 Electrolyte P Injection (Pediatric)) D18007 186
Sl. No.
Drug Name Drug Code Page No.
181 Etoposide Injection IP D24014 187
182 Fluoro uracil Injection IP D24028 188
183 Fluphenazine Decanoate Injection IP D17013 189
184 Frusemide Injection IP D19002 190
185 Gamma globulin (I.V) IP D21020 191
186 Gentamycin Injection IP D02013 192
187 Glycopyrrolate USP D04019 193
188 Haloperidol Injection IP D17012 194
189 Heparin sodium Injection IP D12003 195
190 Human Anti-D Immunoglobulin IP D21011 196
191 Hydrocortisone sodium succinate Injection IP D05002 197
192 Hydroxy Ethyl Starch I.V Infusion D12006 198
193 Iohexol Injection USP D23001 199
194 Ketamine Injection IP D04001 200
195 Leucovorin calcium Injection USP D24015 201
196 Lignocaine 2 % with Adrenaline Injection IP D04018 202
197 Lignocaine Hcl Injection Heavy IP D04005 203
198 Lignocaine Hcl Injection IP D04004 204
199 Lorazepam Injection USP D17034 205
200 Magnesium Sulphate Injection BP D16007 206
201 Mannitol Injection IP D18010 207
202 Methotrexate Injection IP D24010 208
203 Methyl Ergometrin Maleate Injection IP D16004 209
KKEERRAALLAA MMEEDDIICCAALL SSEERRVVIICCEESS CCOORRPPOORRAATTIIOONN LLTTDD QUALITY CONTROL MANUAL FOR DRUGS AND SUPPLIES
Title : Current Index For Drugs and Supplies Page 8 of 13
204 Methyl prednisolone sodium succinate Injection D05012 210
205 Metoclopramide Injection IP D20005 211
206 Metoprolol Injection BP D13019 212
207 Metronidazole Injection IP D02025 213
208 N-Acetyl Cysteine Injection BP D06007 214
209 Naloxone Injection BP D06003 215
210 Neostigmine methylsulphate Injection IP D04008 216
211 Nitroglycerin Injection USP D13028 217
Sl. No.
Drug Name Drug Code Page No.
212 Ofloxacin Injection D02018 218
213 Ondansetron Injection USP D20014 219
214 Oxytocin Injection IP D16001 220
215 Paclitaxel Injection USP D24019 221
216 Pancuronium bromide Injection B.P D04009 222
217 Paracetamol Injection D01009 223
218 Pentazocine lactate Injection IP D01008 224
219 Phenobarbitone sodium Injection IP D07003 225
220 Phenytoin sodium Injection D07008 226
221 Phytomenadione Injection BP D12005 227
222 Potassium chloride for Injection Concentrate USP D18012 228
223 Pralidoxime Chloride Injection IP D06004 229
224 Promethazine Injection IP D05009 230
225 Propofol Injection BP D04010 231
226 Protamine Sulphate Injection IP D12012 233
227 Quinine Injection IP D08010 234
228 Ranitidine Injection IP D20001 235
229 Ringer Lactate Injection IP D18009 236
230 Sodium Calcium Edetate Injection BP D22002&D22004 237
231 Sodium chloride 0.9% & Dextrose 5.0% w/v IP D18002 238
232 Sodium chloride Injection IP 0.9%w/v D18001 239
233 Sodium Nitro Prusside Injection USP D13025 240
KKEERRAALLAA MMEEDDIICCAALL SSEERRVVIICCEESS CCOORRPPOORRAATTIIOONN LLTTDD QUALITY CONTROL MANUAL FOR DRUGS AND SUPPLIES
Title : Current Index For Drugs and Supplies Page 9 of 13
234 Sodium thiosulphate Injection BP D06012 241
235 Sterile Water for Injection IP D18011 242
236 Streptokinase Injection IP D13022 243
237 Succinyl choline Injection IP D04013 244
238 Terbutaline Injection IP D03007 245
239 Tetanus Toxoid Injection IP D21009 246
240 Theophylline and Etophylline Injection D03001 247
241 Thiopentone sodium Injection IP D04014 248
242 Tramadol Injection IP D01011 249
Sl. No.
Drug Name Drug Code Page No.
243 Vancomycin Hydrochloride Injection D02027 250
244 Vecuronium Bromide Injection D04020 251
245 Vincristine Sulphate Injection IP D24002 252
MEDICAL DEVICES 253
246 Absorbable cotton Gauze S27008 254
247 Absorbent Cotton Wool IP S27007 255
248 Adhesive Tape U.S.P. S27002 256
249 Black Braided Silk 1-25 M (Reels) S27104 to S27107 257
250 Black Silk 5-0 ½ C 17mm Needle Taper cut 76 cm S27108 258
251 Blood collection single bag S27010 259
252 BP Blade S27014 to S27021 260
253 Braided Poly Glycolic Acid Suture 1 150cm without Needle
S27184 261
254 Braided Poly Glycolic Acid Suture 1-0 150cm without Needle
S27183 262
255 Braided Poly Glycolic Acid Suture 1-0 90cm ½ Circle Taper Cut
S27179 263
256 Braided Poly Glycolic Acid Suture 190 cm ½ Circle Taper Cut (Heavy) 40mm
S27177 264
257 Braided Poly Glycolic Acid Suture 2-0 150cm without Needle
S27182 265
258 Braided Poly Glycolic Acid Suture 2-0 90cm ½ Circle Reverse Cutting 40mm
S27178 266
259 Braided Poly Glycolic Acid Suture 3-0 45cm 3/8 Circle Reverse Cutting 12mm
S27180 267
260 Catgut Atraumatic No. IRB 63 mm Blunt Needle S27109 268
KKEERRAALLAA MMEEDDIICCAALL SSEERRVVIICCEESS CCOORRPPOORRAATTIIOONN LLTTDD QUALITY CONTROL MANUAL FOR DRUGS AND SUPPLIES
Title : Current Index For Drugs and Supplies Page 10 of 13
261 Catgut Atromatic No. 1, RB, 63 mm S27120&S27121 269
262 Catgut Chromic 1 – 0, RB, 3/8 circle 76 cm, 45mm S27122 270
263 Catgut Chromic 1-0 152 cm Null S27110& S27111 271
264 Catgut Chromic 2-0 ½ CRB 30mm Needle 76 cm S27112 272
265 Catgut Chromic 3-0 ½ 12mm Needle Reverse cut 76 cm
S27113 to S27115 273
266 Catgut No. 1 with Needle S27116 & S27117 274
267 Catgut Plain BP 1-0 152 cm S27118 &S27119 275
268 Disposable Needle S27025 to S27030 276
269 Disposable Surgeon`s mask (Double Layer) S27100 277
Sl. No.
Drug Name Drug Code Page No.
270 Disposable syringe without needle S27031 to S27033 278
271 Endo Tracheal Tube S27045 to S27053 279
272 Endotracheal Tube 5.5 with cuff S27054 to S27061 280
273 Folley’s Catheter S27062 to S27065 281
274 Infant Feeding Tube S27069 to S27074 282
275 Infusion set 283
276 Insulin Syringe with Fixed Needle S27211 284
277 Monofilament Poly Amide 10/0 CS – Ultima ½ Circle Double Needle 6mm
S27167 285
278 Monofilament Poly Amide 10/0 CS – Ultima 3/8 Circle Double Needle 6mm
S27168 286
279 Monofilament Poly Propylene Blue 3-0 70cm 3/8 Circle Cutting 22mm
S27176 287
280 Monofilament Poly Propylene Blue 170cm ½ CRB (Heavy)
S27175 288
281 Monofilament Poly Propylene Blue 1-0 70cm ½ CRB 30mm
S27174 289
282 Monofilament Polyamide 8/0 ½ Circle Reverse Cutting Micro point 8mm
S27169 290
283 Non- Adherent Sterile Rayon Dressing Impregnated with 10 povidone Iodine size 10 x 10cm
S27172 291
284 Oxygen Catheter S27203 to S27205 292
285 Paediatric Bag S27012 293
286 Plaster of Paris Bandages BP S27001 294
KKEERRAALLAA MMEEDDIICCAALL SSEERRVVIICCEESS CCOORRPPOORRAATTIIOONN LLTTDD QUALITY CONTROL MANUAL FOR DRUGS AND SUPPLIES
Title : Current Index For Drugs and Supplies Page 11 of 13
287 Poliglecarpone 25 (Dyed) Size 1/0 with round body
needle for Anastamosis S27128 295
288 Poliglecarpone 25 (Dyed) Size 2/0 with black JB shaped round body needle for Anastamosis
S27130 296
289 Poliglecarpone 25 (Dyed) Size 2/0 with round body needle for Anastamosis
S27129 297
290 Poliglecarpone 25 (Dyed) Size 3/0 with black JB shaped for Anastamosis
S27132 298
291 Poliglecarpone 25 (Dyed) size 3/0 with cutting needle for sub cuticular suturing
S27131 299
292 Poliglecarpone 25 Size 1/0 with round body needle for Anastamosis
S27125 300
293 Poliglecarpone 25 Size 3/0 with visi black JB shaped round body needle For Anastamosis
S27126 301
Sl. No. Drug Name Drug Code Page No.
294 Poly dioxanone of size 1 with ½ Circle RB, Heavy 50mm needle suture length 1.5m, for sheath closure
S27187 302
295 Polyglactin 910 of Size 1, ½ Circle 36mm OB needle made of special grade steel 420 with ribbed body for secure Grip
S27186 303
296 Polyglactin 910 of Size 1, ½ Circle 40mm CT needle made of special grade steal for 420 with ribbed body for secure Grip
S27188 304
297 Polyglacten 910 of Size 1-0, ½ Circle 36mm OB needle made of special grade steel 420 with ribbed body for secure Grip
S27189 305
298 Polyglacten 910 rapid Size 2/0 with taper needle for Episiotomy Repair S27185 306
299 Polyglycolic acid 1-0, 150 cm with out needle S27156 307
300 Polyglycolic acid 1-0, round body, ½ Circle, 40mm, 150cm S27157 308
301 Polyglycolic acid 2-0, taper cut, ½ circle, 30mm, 90cm S27158 309
302 Polyglycolic acid No. 1, ½ circle, 40mm, 90cm S27155 310
303 Polyglycolic acid Size 2/0 with double armed needle for Episiotomy S27124 311
304 Polyglycolic acid with Calcium Stearate size 01 with 36mm reverse cutting ortho special (O.S) needle S27164 312
305 Polyglycolic acid with Calcium Stearate size 5/0 with Ethiprime cutting 12mm S27162 313
KKEERRAALLAA MMEEDDIICCAALL SSEERRVVIICCEESS CCOORRPPOORRAATTIIOONN LLTTDD QUALITY CONTROL MANUAL FOR DRUGS AND SUPPLIES
Title : Current Index For Drugs and Supplies Page 12 of 13
306 Polyglycolic acid with Calcium Stearate size 6/0 with micropoint spatulate 8 mm S27161 314
307 Poly propylene 1, ½ CRB 30 mm needle S27136 to S27141 315
308 Quadraple Bag with SAGM Platelet storage S27011 316
309 Ryle’s Tube S27076 to S27079 317
310 Sics Blade (Sharp Edge) cresant Blade 2.8mm S27201 318
311 Sics Blade (Sharp Edge) Keratomo Blade (2.8mm) S27200 319
312 Sics Blade (Sharp Edge) Side port S27202 320
313 Suction catheter S27089 to S27093 321
314 Surgical silk 2-0 St. RB 50 mm needle 76 cm S27142 to S27149 322
315 Suture pack silk No. 1 S27150 to S27154 323
316 Virgin Silk 8/0 3/8 Circle micropoint spatulated 6mm needle S27165 324
Sl. No.
Drug Name Drug Code Page No.
317 Virgin Silk 8/0 3/8 Circle micropoint spatulated double needle
S27166 325
MISCELLANEOUS 326
318 Activated Charcoal Powder IP. D06002 327
319 Black Disinfectant Fluid Grade-III D25012 328
320 Bleaching Powder 30 % IP D25011 329
321 Gentian Violet Paint BPC D14017 330
322 Liquid Paraffin IP D14003 331
323 Nitrous oxide IP D04015 332
324 Oxygen IP D04016 333
325 Purified Talc IP D14016 334
326 Surgical Spirit 70.0%v/v BP D25002 335
327 Washing soda D25013 336
328 White Soft Paraffin IP D14015 337
GENERAL TESTS 338
329 General test 339
330 General test for Tablets 340,341
331 General test for Capsules 342
332 General test for Oral liquids 343
KKEERRAALLAA MMEEDDIICCAALL SSEERRVVIICCEESS CCOORRPPOORRAATTIIOONN LLTTDD QUALITY CONTROL MANUAL FOR DRUGS AND SUPPLIES
Title : Current Index For Drugs and Supplies Page 13 of 13
333 General test for Powders 344
334 General test for Gels 345
335 General test for Creams 346
336 General test for Ointments 347
337 General test for Pesseries 348
338 General test for Suppositories 349
339 General test for Ear drops/Eye drops 350
340 General test for Eye ointment 351
341 General test for Nasal Drops 352
342 General test for Parenterals as per IP 353 to356
343 General test for Parenterals as per BP 357 to364
344 General test for Parenterals as per USP 365 to368
345 General test for Sutures 369to372
Sl. No
Drug Name Drug Code Page No
346
References 373
347
Abbreviations 374
KKEE
RRAA
LLAA
MM
EEDD
II CCAA
LL
SSEE
RRVV
II CCEE
SS
CCOO
RRPP
OORR
AATT
II OONN
LL
TTDD
TTAABBLLEETTSS
QQuuaalliittyy CCoonnttrrooll MMaannuuaall FFoorr
DDrruuggss AAnndd SSuupppplliieess
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D01018
Quality Control Department
Drug Name : Acetyl Salicylic Acid Tablets IP Page 1 of 1
Synonym : Aspirin Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 694-695
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
2
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Salicylic acid 4. Uniformity of weight- Refer-G-TAB-002 5. Disintegration- Refer- G-TAB-004 6. Assay: limit-95.0-105.0% of the stated amount of Aspirin.
ADDITIONAL TESTS
1. Friability - Not more than 1.0% 2. Hardness - Minimum 3 kg/cm square.
LIMITS
For test 1 to 6, limit as per IP-2007.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D09002
Quality Control Department Drug Name :
Acyclovir Tablets IP Page 1 of 1 Synonym :
Copy No. 1 Official Standards :
Indian Pharmacopoeia 2007, Volume 2, Page No. 687-688
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
3
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Guanine 4. Related substances. 5. Uniformity of weight – Refer G-TAB -002 6. Disintegration – Refer G-TAB -004 7. Assay: -95.0% to 105.0% of the stated amount of Acyclovir.
ADDITIONAL TESTS
3. Friability - Not more than 1.0% 4. Hardness - Minimum 3 kg/cm square.
LIMITS
For test 1 to 7, limit as per IP-2007.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D08001
Quality Control Department
Drug Name : Albendazole Tablets IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 692-693
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
4
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Uniformity of Weight- Refer-G-TAB-002. 4. Disintegration – Refer G-TAB-004 5. Assay: Limit- 92.5 to 107.5% of the stated amount of Albendazole.
ADDITIONAL TESTS
5. Friability - Not more than 1.0% 6. Hardness - Minimum 3 kg/cm square.
LIMITS
For test 1 to 5, limit as per IP-2007.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D01013
Quality Control Department
Drug Name : Allopurinol Tablets IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 694-695
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
5
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Related substances. 4. Uniformity of weight- refer-G-TAB-002 5. Disintegration- refer- G-TAB-004 6. Assay: limit- 92.5-107.5% of the stated amount of Allopurinol.
ADDITIONAL TESTS
7. Friability - Not more than 1.0% 8. Hardness - Minimum 3 kg/cm square.
LIMITS
For test 1 to 6, limit as per IP-2007.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D20003
Quality Control Department
Drug Name : Aluminium Hydroxide Tablets IP Page 1 of 1
Synonym : Copy No.
Official Standards : Indian Pharmacopoeia 1985
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
6
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Uniformity of content -Refer- G-TAB-001 4. Disintegration – Refer G-TAB -004 5. Assay: - 90.0% to 110.0% of the stated amount of Alprazolam.
ADDITIONAL TESTS
Friability - Not more than 1.0%.
LIMITS
For test 1 to 5, limit as per IP-2007.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D20003
Quality Control Department
Drug Name : Aluminium Hydroxide Tablets IP Page 1 of 1
Synonym : Copy No.
Official Standards : Indian Pharmacopoeia 1985
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
7
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Uniformity of weight Refer- G-TAB-002 4. Disintegration – Refer-G-TAB-004 (not applicable to chewable tablets) 5. Neutralizing capacity- NLT 230 ml of 0.1 M Hydrochloric Acid for each gram
of Dried Aluminium hydroxide Gel. 6. Assay: - Limit as per IP 1985.
ADDITIONAL TESTS
9. Friability - Not more than 1.0% 10. Hardness - Minimum 3 kg/cm square.
LIMITS
For test 1 to 6, limit as per IP-1985.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D17005
Quality Control Department
Drug Name : Amitriptylline Tablets IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 712-713
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
8
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Related substances-HPLC 4. Uniformity of weight - Refer- G-TAB-001 5. Dissolution – D value 75.0% Refer- G-TAB-003 6. Assay:- 90.0% to 110.0% of the stated amount of Amitriptylline.
ADDITIONAL TESTS
Friability - Not more than 1.0%
LIMITS
For test 1 to 6, limit as per IP-2007.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D13012 & D13031 Quality Control Department
Drug Name : Amlodipine Tablets IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 715-716
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
9
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification- HPLC 3. Related substances- HPLC 4. Uniformity of content - Refer- G-TAB-001 5. Dissolution – D value 70.0% Refer- G-TAB-003 6. Assay:- 90.0% to 110.0% of the stated amount of Amlodipine.
ADDITIONAL TESTS
Friability - Not more than 1.0%
LIMITS
For test 1 to 6, limit as per IP-2007.
LABELLING
The label states the strength in terms of the equivalent amount of Amlodipine.
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D02003
Quality Control Department
Drug Name : Amoxycillin Dispersible Tablets IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 723
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
10
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Uniformity of weight- Refer-G-TAB-002 4. Disintegration- limit-30 minutes, Refer- G-TAB-004 5. Uniformity of dispersion-Refer-G-TAB-005 6. Assay: limit-90.0-120.0% of the stated amount of Amoxicillin
ADDITIONAL TESTS
Friability - Not more than 1.0%
LIMITS
For test 1 to 6, limit as per IP-2007.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D13008
Quality Control Department
Drug Name : Atenolol Tablets IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 749
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
11
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Related substances 4. Uniformity of weight. Refer- G-TAB-002 5. Disintegration- Refer-G-TAB-004 6. Assay: - limit not less than 92.5% and not more than 107.5% of stated
amount of Atenolol.
ADDITIONAL TESTS
11. Friability - Not more than 1.0% 12. Hardness - Minimum 3 kg/cm square.
LIMITS
For test 1 to 6, limit as per IP-2007.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D13013
Quality Control Department
Drug Name : Atorvastatin Tablets IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 751-752
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
12
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Related substances-HPLC 4. Dissolution – Refer G-TAB -004 5. Uniformity of weight -Refer- G-TAB-002 6. Assay: - 90.0% to 110.0% of the stated amount of Atorvastatin.
ADDITIONAL TESTS
Friability - Not more than 1.0%
LIMITS
For test 1 to 6, limit as per IP-2007.
LABELLING
The label states the strength in terms of the equivalent amount of Atorvastatin.
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D02030
Quality Control Department
Drug Name : Azithromycin Tablets IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 761
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
13
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Related substances- HPLC 4. Water- NMT 6.0 % 5. Dissolution – D –value NLT 75.0%. Refer G-TAB -004 6. Uniformity of weight -Refer- G-TAB-002 7. Assay:- 90.0% to 110.0% of the stated amount of Azithromycin.
ADDITIONAL TESTS
13. Friability - Not more than 1.0% 14. Hardness - Minimum 3 kg/cm square.
LIMITS
For test 1 to 7, limit as per IP-2007.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D20012
Quality Control Department
Drug Name : Bisacodyl Tablets IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 808
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
14
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification- HPLC 3. Uniformity of content- Refer -G-TAB-001 4. Disintegration – Refer G-TAB-004 5. Assay: - Limit 95.0% to 105.0% of the stated amount of Bisacodyl.
ADDITIONAL TESTS
Nil
LIMITS
For test 1 to 5, limit as per IP-2007.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D22001
Quality Control Department
Drug Name : Calcium Lactate Tablets IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 843
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
15
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Uniformity of weight- Refer- G-TAB-002 4. Disintegration – Refer-G-TAB-004 (Limit not more than 30 minutes) 5. Assay: - Limit not less than 95.0% and not more than 105.0% of stated
amount of Calcium Lactate Pentahydrate.
ADDITIONAL TESTS
15. Friability - Not more than 1.0% 16. Hardness - Minimum 3 kg/cm square.
LIMITS
For test 1 to 5, limit as per IP-2007.
LABELLING
The label states the strength in terms of the equivalent amount of Calcium Lactate Pentahydrate.
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D07005
Quality Control Department
Drug Name : Carbamazepine Tablets IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 851-852
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
16
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Related substances - HPLC 4. Uniformity of weight – Refer- G-TAB 002 5. Disintegration – Refer - G-TAB-004 6. Assay: limit- 95.0-105.0% of the stated amount of Carbamazepine.
ADDITIONAL TESTS
17. Friability - Not more than 1.0% 18. Hardness - Minimum 3 kg/cm square.
LIMITS
For test 1 to 6, limit as per IP-2007.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D11002
Quality Control Department
Drug Name : Carbidopa and Levodopa Tablets IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 1293-1294
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
17
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Uniformity of Content- Refer-G-TAB-001 4. Disintegration- Refer- G-TAB-004 5. Assay: limit- 90.0-110.0% of the stated amount of anhydrous Carbidopa
and 95.0 to 105.0 % of the stated amount of Levodopa.
ADDITIONAL TESTS
Nil
LIMITS
For test 1 to 5, limit as per IP-2007.
LABELLING
The label states the quantity of Carbidopa in terms of the equivalent amount of anhydrous Carbidopa and the quantity of Levodopa in each tablet.
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D05010
Quality Control Department
Drug Name : Cetirizine Tablet IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 893
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
18
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Related substances 4. Uniformity of content -Refer- G-TAB-001 5. Dissolution – D –value NLT 75.0% Refer G-TAB -003 6. Assay:- 90.0% to 110.0% of the stated amount of Cetirizine Hydrochloride.
ADDITIONAL TESTS
Friability - Not more than 1.0%
LIMITS
For test 1 to 6, limit as per IP-2007.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D17009
Quality Control Department
Drug Name : Chlordiazepoxide Tablets IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 906
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
19
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Related substances 4. Uniformity of content -Refer- G-TAB-001 5. Disintegration – Refer G-TAB -004 6. Assay: - 90.0% to 110.0% of the stated amount of Chlordiazepoxide.
ADDITIONAL TESTS
19. Friability - Not more than 1.0% 20. Hardness - Minimum 3 kg/cm square.
LIMITS
For test 1 to 6, limit as per IP-2007.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D08009
Quality Control Department
Drug Name : Chloroquine Phosphate Tablets IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 915
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
20
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Related substances. 4. Dissolution - D value 70.0% , Refer G-TAB - 003 5. Uniformity of weight – Refer G-TAB- 002 6. Disintegration Refer - G-TAB- 004 7. Assay: - 92.5% to 107.5% of the stated amount of Chloroquine Phosphate.
ADDITIONAL TESTS
21. Friability - Not more than 1.0% 22. Hardness - Minimum 3 kg/cm square.
LIMITS For test 1 to 7, limit as per IP-2007.
LABELLING Nil QUANTITY REQUIRED FOR ANALYSIS 100 Numbers.
SHELF LIFE Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D05006
Quality Control Department
Drug Name : Chlorpheniramine Maleate Tablets IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 920-921
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
22
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Related substances 4. Uniformity of content- Refer-G-TAB-001 5. Disintegration- Refer- G-TAB-004 6. Assay: limit- 95.0-105.0% of the stated amount of Chlorpheniramine
Maleate.
ADDITIONAL TESTS
Nil
LIMITS
For test 1 to 6, limit as per IP-2007.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D17002
Quality Control Department
Drug Name : Chlorpromazine Tablets IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 922-923
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
22
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Related substances. 4. Uniformity of content -Refer- G-TAB-001 5. Disintegration – Refer G-TAB -004 6. Assay: - 92.5% to 110.0% of the stated amount of Chlorpromazine.
ADDITIONAL TESTS
23. Friability - Not more than 1.0% 24. Hardness - Minimum 3 kg/cm square.
LIMITS
For test 1 to 6, limit as per IP-2007.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D02011
Quality Control Department
Drug Name : Ciprofloxacin Tablets IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 939-940
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
23
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Uniformity of Weight- Refer-G-TAB-002. 4. Dissolution- D-value- 80.0%. Refer- G-TAB-003. 5. Assay: Limit- 90.0-110.0% of the stated amount of Ciprofloxacin.
ADDITIONAL TESTS
25. Friability - Not more than 1.0% 26. Hardness - Minimum 3 kg/cm square.
LIMITS
For test 1 to 6, limit as per IP-2007.
LABELLING
The label states the strength in terms of the equivalent amount of Ciprofloxacin.
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D07009
Quality Control Department
Drug Name : Clobazam Tablets Page 1 of 1
Synonym : Copy No. 1
Official Standards :
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
24
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Uniformity of Weight- Refer-G-TAB-002. 4. Disintegration –Refer-G-TAB-004 5. Assay: -HPLC - Limit not less than 90.0% and not more than 110.0% of the
stated amount of Clobazam.
ADDITIONAL TESTS
27. Friability - Not more than 1.0% 28. Hardness - Minimum 3 kg/cm square.
LIMITS
For test 3 and 4, limit as per IP-2007.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D16009
Quality Control Department
Drug Name : Clomifene Tablets IP Page 1 of 1
Synonym : Clomifene Citrate Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 950
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
25
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Z-isomer- HPLC 4. Dissolution – D –value NLT 80.0%. Refer G-TAB -004 5. Uniformity of weight -Refer- G-TAB-002 6. Assay: -92.5% to 107.5% of the stated amount of Clomifene citrate.
ADDITIONAL TESTS
Friability - Not more than 1.0%
LIMITS
For test 1 to 6, limit as per IP-2007.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D13023
Quality Control Department
Drug Name : Clopidogrel Tablets IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Addendum, Page No.
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
26
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Related substances 4. Uniformity of content -Refer- G-TAB-001 5. Dissolution – D value NLT 80.0% Refer G-TAB -003 6. Assay: - 90.0% to 110.0% of the stated amount of Clopidogrel.
ADDITIONAL TESTS
Friability - Not more than 1.0%
LIMITS
For test 1 to 6, limit as per IP-2007.
LABELLING
The label states the strength in terms of the equivalent amount of Clopidogrel.
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D08008
Quality Control Department
Drug Name : Clotrimazole Vaginal Tablets IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 958-959
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
27
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Related substances - HPLC 4. Uniformity of content - Refer G-PES- 001 5. Uniformity of weight – Refer G-PES- 002 6. Disintegration - G-PES -003 7. Assay: - 95.0% - 105.0% of the stated amount of Clotrimazole.
ADDITIONAL TESTS
Nil
LIMITS
For test 1 to 7, limit as per IP-2007.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D17014
Quality Control Department
Drug Name : Clozapine Tablets USP Page 1 of 1
Synonym : Copy No. 1
Official Standards : US Pharmacopoeia 2008, Volume 2, Page No. 1833
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
28
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Dissolution – D value 85.0% (Q) of the labelled amount of Clozapine. 4. Chromatographic purity. 5. Uniformity of dosage units. 6. Assay: - 90.0% to 110.0% of the labelled amount of Clozapine.
ADDITIONAL TESTS
29. Friability - Not more than 1.0% 30. Hardness - Minimum 3 kg/cm square.
LIMITS
For test 1 to 6, limit as per USP-2008.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
120 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D02001
Quality Control Department
Drug Name : Co-trimoxazole Tablets IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 3, Page No. 1833-1834
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
29
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Uniformity of weight- Refer-G-TAB-002 4. Disintegration-D-value-80.0%- Refer- G-TAB-004 5. Assay: limit- 92.5%-107.5% of the stated amount of Trimethoprim and
Sulphamethoxazole.
ADDITIONAL TESTS
31. Friability - Not more than 1.0% 32. Hardness - Minimum 3 kg/cm square.
LIMITS
For test 1 to 5, limit as per IP-2007.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D05003
Quality Control Department
Drug Name : Dexamethasone Tablets IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 1004-1005
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
30
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Related substances-HPLC 4. Uniformity of content- Refer-G-TAB-001 5. Disintegration- Refer- G-TAB-004 6. Assay: limit- 90.0-110.0% of the stated amount of Dexamethasone.
ADDITIONAL TESTS
Nil
LIMITS
For test 1 to 6, limit as per IP-2007.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D17001
Quality Control Department
Drug Name : Diazepam Tablets IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 1018-1019
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
31
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Related substances and Decomposition product. 4. Dissolution – D value-85.0%,Refer G-TAB -004 5. Uniformity of content -Refer- G-TAB-001 6. Assay:- 92.5% to 107.5% of the stated amount of Diazepam.
ADDITIONAL TESTS
Friability - Not more than 1.0%
LIMITS
For test 1 to 6, limit as per IP-2007.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D01004
Quality Control Department
Drug Name : Diclofenac Sodium Tablets IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 1021-1022
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
32
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Salicylic acid 4. Uniformity of weight- Refer-G-TAB-002 5. Disintegration- Refer- G-TAB-004 6. Assay: limit-95.0-105.0% of the stated amount of Diclofenac sodium.
ADDITIONAL TESTS
1. Friability-not more than 1.0% 2. Hardness- minimum 3 kg/cm square.
LIMITS
For test 1 to 6, limit as per IP-2007.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D20008
Quality Control Department
Drug Name : Dicyclomine Hydrochloride Tablets IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 1024
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
33
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Related substances 4. Dissolution – Refer G-TAB -004 5. Uniformity of content - Refer- G-TAB-001 6. Assay:- 90.0% to 110.0% of the stated amount of Dicyclomine Hydrochloride.
ADDITIONAL TESTS
Friability - Not more than 1.0%
LIMITS
For test 1 to 6, limit as per IP-2007.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D13014
Quality Control Department
Drug Name : Digoxin Tablets IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 1037-1038
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
34
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. N1 N1 Diethyl piperazine and N-methyl piperazine 4. Dissolution - D value 75.0%, Refer G-TAB-003 5. Uniformity of weight – Refer G-TAB-002 6. Assay: Limit- 92.5 to 107.5 % of the stated amount of Diethylcarbamazine.
ADDITIONAL TESTS
1. Friability - Not more than 1.0% 2. Hardness - Minimum 3 kg/cm square.
LIMITS
For test 1 to 6, limit as per IP-2007.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D13014
Quality Control Department
Drug Name : Digoxin Tablets IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 1037-1038
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
35
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Dissolution – Refer G-TAB -004 4. Uniformity of weight -Refer- G-TAB-002 5. Assay:- 90.0% to 110.0% of the stated amount of Digoxin.
ADDITIONAL TESTS
Friability - Not more than 1.0%
LIMITS
For test 1 to 6, limit as per IP-2007.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D13004
Quality Control Department
Drug Name : Diltiazem Tablets IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 1042-1043
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
36
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Dissolution- Limit- NLT 60.0% of the stated amount of Diltiazem HCl is
dissolved in 30.0 minutes and NLT 80.0% in 3.0 hours. Refer- G-TAB-003 4. Uniformity of weight- Refer-G-TAB-002 5. Assay: limit-90.0-110.0% of the stated amount of Diltiazem HCl.
ADDITIONAL TESTS
1. Friability - Not more than 1.0% 2. Hardness - Minimum 3 kg/cm square.
LIMITS
For test 1 to 5, limit as per IP-2007.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D20007
Quality Control Department
Drug Name : Domperidone Tablets IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 1052-1053
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
37
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Dissolution – Refer G-TAB -003 4. Related substances - HPLC 5. Uniformity of content - Refer- G-TAB-001 6. Assay:- 95.0% to 105.0% of the stated amount of Domperidone.
ADDITIONAL TESTS
Friability - Not more than 1.0%
LIMITS
For test 1 to 6, limit as per IP-2007.
LABELLING
The label states the strength in terms of the equivalent amount of Domperidone.
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D13009
Quality Control Department
Drug Name : Enalapril Maleate Tablets IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 1078-1079
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
38
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Uniformity of content -Refer- G-TAB-001 4. Disintegration – Refer G-TAB -004 5. Assay: -90.0% to 110.0% of the stated amount of Enalapril Maleate.
ADDITIONAL TESTS
Friability - Not more than 1.0%
LIMITS
For test 1 to 5, limit as per IP-2007.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D02015
Quality Control Department
Drug Name : Erythromycin Stearate Tablets IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 1094-1095
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
39
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Uniformity of Weight- Refer-G-TAB-002. 4. Disintegration- Refer- G-TAB-004 5. Assay: limit- 90.0-115.0% of the stated amount of Erythromycin.
ADDITIONAL TESTS
3. Friability - Not more than 1.0% 4. Hardness - Minimum 3 kg/cm square.
LIMITS
For test 1 to 5, limit as per IP-2007.
LABELLING
The label states the strength in terms of the equivalent amount of Erythromycin.
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D22006
Quality Control Department
Drug Name : Ferrous Sulphate Tablets IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 1125-1126
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
40
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Uniformity of weight – Refer- GTAB-002 4. Disintegration- Refer- GTAB-004 5. Assay:- Limit- 80.0 to 90.0% of the stated amount of Ferrous Sulphate.
ADDITIONAL TESTS
1. Friability - Not more than 1.0% 2. Hardness - Minimum 3 kg/cm square.
LIMITS
For test 1 to 5, limit as per IP-2007.
LABELLING
The label states the quantity of the active ingredient both as the amount of dried ferrous sulphate and in terms of the equivalent amount of ferrous ions in each tablet.
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D08014
Quality Control Department
Drug Name : Fluconazole Tablets Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 939-940
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
41
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Uniformity of Weight- Refer-G-TAB-002. 4. Disintegration –Refer-G-TAB-004 5. Assay: - HPLC - Limit not less than 90.0% and not more than 110.0% of
stated amount of Fluconazole.
ADDITIONAL TESTS
1. Friability - Not more than 1.0% 2. Hardness - Minimum 3 kg/cm square.
LIMITS
For test 3 and 4, limit as per IP-2007.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
160 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D12002
Quality Control Department
Drug Name : Folic Acid Tablets IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 1144-1145
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
42
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification- HPLC 3. Hydrolysis product -HLPC 4. Uniformity of content -Refer- G-TAB-001 5. Disintegration – Refer -G-TAB -004 6. Assay: -95.0% to 115.0% of the stated amount of Folic acid.
ADDITIONAL TESTS
1. Friability - Not more than 1.0% 2. Hardness - Not more than 1.0%
LIMITS
For test 1 to 6, limit as per IP-2007.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D19001
Quality Control Department
Drug Name : Frusemide Tablets IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 1151
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
43
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification- HPLC 3. Free amines. 4. Uniformity of weight – Refer G-TAB-002 5. Disintegration – Refer G-TAB-004 6. Assay: - Limit 90.0% to 110.0% of the stated amount of Frusemide
ADDITIONAL TESTS
1. Friability - Not more than 1.0% 2. Hardness - Minimum 3 kg/cm square.
LIMITS
For test 1 to 6, limit as per IP-2007.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D21001 & D21002 Quality Control Department
Drug Name : Glibenclamide Tablets IP Page 1 of 1
Synonym : Copy No.
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 1166-1167
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
44
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Related substances. 4. Uniformity of content - Refer- G-TAB-001 5. Disintegration – Refer- G-TAB-004 6. Assay: - 90.0% to 110.0% of the stated amount of Glibenclamide.
ADDITIONAL TESTS
Friability - Not more than 1.0%
LIMITS
For test 1 to 6, limit as per IP-2007.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D21004
Quality Control Department
Drug Name : Glipizide Tablets IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 1168
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
45
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Related substances 4. Uniformity of content - Refer- G-TAB-001 5. Disintegration – Refer G-TAB -004 6. Assay:- 90.0% to 110.0% of the stated amount of Glipizide.
ADDITIONAL TESTS
Friability - Not more than 1.0%
LIMITS
For test 1 to 6, limit as per IP-2007.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D08005
Quality Control Department
Drug Name : Griseofulvin Tablets IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 1175-1176
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
46
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Related substance – gas chromatography 4. Dissolution- D value 70.0%. Refer-G-TAB-003 5. Uniformity of weight – Refer G-TAB-002 6. Disintegration – Refer G-TAB-004 7. Assay: limit-95.0% - 105.0% of the stated amount of Griseofulivin.
ADDITIONAL TESTS
1. Friability - Not more than 1.0% 2. Hardness - Minimum 3 kg/cm square.
LIMITS
For test 1 to 7, limit as per IP-2007.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D17010
Quality Control Department
Drug Name : Haloperidol Tablets IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 1183
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
47
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Related substance – gas chromatography 4. Dissolution- D value 70.0%. Refer-G-TAB-003 5. Uniformity of weight – Refer G-TAB-002 6. Disintegration – Refer G-TAB-004 7. Assay: limit-95.0% - 105.0% of the stated amount of Griseofulivin.
ADDITIONAL TESTS
3. Friability - Not more than 1.0% 4. Hardness - Minimum 3 kg/cm square.
LIMITS
For test 1 to 7, limit as per IP-2007.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D01006 & D01016 Quality Control Department
Drug Name : Ibuprofen Tablets IP (Film Coated) Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 1218
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
48
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Related substance 4. Uniformity of weight- Refer-G-TAB-002 5. Dissolution- Refer- D-value-50.0%G-TAB-003 6. Assay: Limit-95.0-105.0% of the stated amount of Ibuprofen.
ADDITIONAL TESTS
Nil
LIMITS
For test 1 to 6, limit as per IP-2007.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D17004
Quality Control Department
Drug Name : Imipramine Tablets IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 1223-1224
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
49
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Related Substances. 4. Uniformity of weight -Refer- G-TAB-002 5. Disintegration – Refer -G-TAB -004 6. Assay: - 92.5% to 107.5% of the stated amount of Imipramine
Hydrochloride.
ADDITIONAL TESTS
Friability - Not more than 1.0%
LIMITS
For test 1 to 6, limit as per IP-2007.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D13001 & D13002 Quality Control Department
Drug Name : Isosorbide Dinitrate Tablets IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 1254-1255
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
50
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification- HPLC 3. Inorganic nitrate. 4. Related substances. 5. Uniformity of content - Refer- G-TAB-001 6. Dissolution – D value 80.0% Refer- G-TAB-003 7. Assay: -90.0% to 110.0% of the stated amount of Isosorbide Dinitrate.
ADDITIONAL TESTS
Friability - Not more than 1.0%
LIMITS
For test 1 to 7, limit as per IP-2007.
LABELLING
The label states whether the tablets are to be swallowed whole, chewed before swallowing for allowing to dissolve in the mouth.
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D13003
Quality Control Department
Drug Name : Isosorbide 5 Mononitrate Tablets BP Page 1 of 1
Synonym : Copy No. 1
Official Standards : British Pharmacopoeia 2009, Volume 3, Page No. 2703
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
51
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Inorganic nitrates 4. Isosorbide Dinitrate and Isosorbide 2 -nitrate 5. Uniformity of weight Refer- G-TAB-002 6. Disintegration –Refer-G-TAB-004 (not applicable to chewable tablets) 7. Assay:- 95.0 to 105.0 % of the stated amount of Isosorbide Mononitrate.
ADDITIONAL TESTS
Friability - Not more than 1.0%
LIMITS
For test 1 to 6, limit as per BP-2009.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D08006
Quality Control Department
Drug Name : Ketoconazole Tablets IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 1268
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
52
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Uniformity of Weight- Refer-G-TAB-002. 4. Disintegration – Refer- G-TAB-004 5. Assay: Limit- 95.0% - 105.0% of the stated amount of Ketoconazole.
ADDITIONAL TESTS
1. Friability - Not more than 1.0% 2. Hardness - Minimum 3 kg/cm square.
LIMITS
For test 1 to 5, limit as per IP-2007.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D17025 & D17026 Quality Control Department
Drug Name : Lithium Carbonate Tablets IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 1309
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
53
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Dissolution – D value-60.0%, Refer G-TAB -004 4. Uniformity of weight - Refer- G-TAB-002 5. Assay: - 95.0% to 105.0% of the stated amount of Lithium Carbonate.
ADDITIONAL TESTS
Friability - Not more than 1.0%
LIMITS
For test 1 to 5, limit as per IP-2007.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D17033
Quality Control Department
Drug Name : Lorazepam Tablets BP Page 1 of 1
Synonym : Copy No. 1
Official Standards : British Pharmacopoeia 2009, Volume 3, Page No. 2734-2725
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
54
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Dissolution – D value 75.0% (Q) of the stated amount of Lorazepam. 4. Related substances 5. Uniformity of content 6. Assay:- 90.0% to 110.0% of the stated amount of Lorazepam.
ADDITIONAL TESTS
Friability - Not more than 1.0%
LIMITS
For test 1 to 6, limit as per BP-2009.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D13011
Quality Control Department
Drug Name : Losartan Potassium Tablets IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 1320
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
55
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Related substances- HPLC 4. Dissolution – D –value NLT 75.0%. Refer G-TAB -004 5. Uniformity of weight -Refer- G-TAB-002 6. Assay:- 90.0% to 110.0% of the stated amount of Losartan Potassium.
ADDITIONAL TESTS
Friability - Not more than 1.0%
LIMITS
For test 1 to 6, limit as per IP-2007.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D01013
Quality Control Department
Drug Name : Mefenamic Acid Tablets BP Page 1 of 1
Synonym : Copy No. 1
Official Standards : British Pharmacopoeia 2009, Volume 3, Page No. 2746
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
56
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. 2,3-dimethyl aniline. 4. Related substances. 5. Uniformity of content- Refer-Page-2257 BP 6. Disintegration- Refer- G-TAB-004 7. Assay: limit- 95.0-110.0% of the stated amount of Mefenamic acid.
ADDITIONAL TESTS
33. Friability - Not more than 1.0% 34. Hardness - Minimum 3 kg/cm square.
LIMITS For test 1 to 7, limit as per BP-2009. LABELLING Nil QUANTITY REQUIRED FOR ANALYSIS 100 Numbers. SHELF LIFE Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D21003
Quality Control Department
Drug Name : Metformin Tablets IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 1359-1360
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
57
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Related substances 4. Dissolution – D value not less than 70.0% of the stated amount of Metformin
Hydrochloride - Refer-G-TAB-003 5. Uniformity of weight. Refer- G-TAB-002 6. Assay: - HPLC - limit not less than 95.0% and not more than 105.0% of
stated amount of Metformin Hydrochloride.
ADDITIONAL TESTS
1. Friability - Not more than 1.0% 2. Hardness - Minimum 3 kg/cm square.
LIMITS
For test 1 to 6, limit as per IP-2007.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D16003
Quality Control Department
Drug Name : Methyl Ergometrine Tablets IP Page 1 of 1
Synonym : Methyl Ergonovin Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 1371-1372
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
58
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Related substances. 4. Uniformity of content -Refer- G-TAB-001 5. Disintegration – Refer G-TAB -004 6. Assay: - 90.0% to 110.0% of the stated amount of Methyl Ergometrine
Maleate.
ADDITIONAL TESTS
Friability - Not more than 1.0%
LIMITS
For test 1 to 6, limit as per IP-2007.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D20006
Quality Control Department
Drug Name : Metoclopramide Tablets IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 1380-1381
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
59
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Related substances 4. Uniformity of content -Refer- G-TAB-001 5. Disintegration – Refer G-TAB -004 6. Assay:- 90.0% to 110.0% of the stated amount of Anhydrous Metoclopramide
Hydrochloride.
ADDITIONAL TESTS
Friability - Not more than 1.0%
LIMITS
For test 1 to 6, limit as per IP-2007.
LABELLING
The label states the strength in terms of the equivalent amount of anhydrous Metoclopramide Hydrochloride.
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D13020 & D13033 Quality Control Department
Drug Name : Metoprolol Tablets IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 1381-1382
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
60
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Dissolution – D value not less than 80.0% of the stated amount of
Metoprolol Tartrate, Refer-G-TAB-003 4. Uniformity of weight Refer- G-TAB-002 5. Assay: - HPLC - limit not less than 90.0% and not more than 110.0% of
stated amount of Metoprolol Tartrate.
ADDITIONAL TESTS
3. Friability - Not more than 1.0% 4. Hardness - Minimum 3 kg/cm square.
LIMITS
For test 1 to 5, limit as per IP-2007.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D02023 & D02024 Quality Control Department
Drug Name : Metronidazole Tablets IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 3, Page No. 1384-1385
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
61
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Related substances 4. Uniformity of Weight- Refer-G-TAB-002 5. Dissolution- D-value- 85.0%- Refer- G-TAB-003 6. Assay: limit- 95.0-105.0% of the stated amount of Metronidazole.
ADDITIONAL TESTS
1. Friability - Not more than 1.0% 2. Hardness - Minimum 3 kg/cm square.
LIMITS
For test 1 to 6, limit as per IP-2007.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D13021
Quality Control Department
Drug Name : Nicotinic Acid Tablets IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 3, Page No. 1440
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
62
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Uniformity of Weight- Refer-G-TAB-002. 4. Disintegration –Refer-G-TAB-004 5. Assay: - Limit not less than 92.5% and not more than 107.5% of stated
amount of Nicotinic acid.
ADDITIONAL TESTS
1. Friability - Not more than 1.0% 2. Hardness - Minimum 3 kg/cm square.
LIMITS
For test 1 to 5, limit as per IP-2007.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D13005
Quality Control Department
Drug Name : Nifedipine Tablets IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 3, Page No. 1444-1445
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
63
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Uniformity of content - Refer- G-TAB-001 4. Uniformity of weight- Refer- G-TAB-002, if the tablet is sustained release. 5. Disintegration – Refer G-TAB -004 6. Dissolution – If the tablet is sustained release.Refer-G-TAB-003
Limits- (1) In acid, D value is NLT 25.0% and NMT 45.0% of the stated amount of Nifedipine, (2) In buffer D value is NLT 60.0% of the stated amount of Nifedipine.
7. Assay: - Limit not less than 90.0% and not more than 110.0% of stated amount of Nifedipine.
ADDITIONAL TESTS
Nil
LIMITS
For test 1 to 7, limit as per IP-2007.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D17006
Quality Control Department
Drug Name : Nitrazepam Tablets IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 3, Page No. 1447-1448
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
64
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Related substances 4. Uniformity of content -Refer- G-TAB-001 5. Disintegration – Refer G-TAB -004 6. Assay:- 90.0% to 110.0% of the stated amount of Nitrazepam.
ADDITIONAL TESTS
Friability - Not more than 1.0%
LIMITS
For test 1 to 6, limit as per IP-2007.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D02016
Quality Control Department
Drug Name : Norfloxacin Tablets IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 3, Page No. 1456-1457
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
65
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Dissolution-D-value- NLT-70.0%- REFER- G-TAB-003 4. Uniformity of weight- Refer-G-TAB-002 5. Assay: limit-95.0-105.0% of the stated amount of Norfloxacin.
ADDITIONAL TESTS
1. Friability - Not more than 1.0% 2. Hardness - Minimum 3 kg/cm square.
LIMITS
For test 1 to 5, limit as per IP-2007.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D02017
Quality Control Department
Drug Name : Ofloxacin Tablets IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 4, Page No. 1470
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
66
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Uniformity of Weight- Refer-G-TAB-002. 4. Dissolution-D-value-75.0%-Refer-TAB-003 5. Related substances. 6. Assay: limit-90.0 to 110.0% of the stated amount of Ofloxacin.
ADDITIONAL TESTS
1. Friability - Not more than 1.0% 2. Hardness - Minimum 3 kg/cm square.
LIMITS
For test 1 to 6, limit as per IP-2007.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D17016 & D17020 Quality Control Department
Drug Name : Olanzepine Tablets IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 3, Page No. 1471-1472
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
67
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Dissolution – D value not less than 70.0% of the labelled amount of
Olanazepine. Refer-G-TAB-003 4. Uniformity of weight Refer- G-TAB-002 5. Assay: -HPLC -limit not less than 90.0% and not more than 110.0% of stated
amount of Olanzepine.
ADDITIONAL TESTS
1. Friability - Not more than 1.0% 2. Hardness - Minimum 3 kg/cm square.
LIMITS
For test 1 to 5, limit as per IP-2007.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D01012
Quality Control Department
Drug Name : Tramadol Tablets Page 1 of 1
Synonym : Copy No. 1
Official Standards :
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
68
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Uniformity of weight - Refer- G-TAB-002 4. Disintegration –Refer-G-TAB-004 5. Assay: - HPLC - Limit not less than 90.0% and not more than 110.0% of
stated amount of Tramadol hydrochloride.
ADDITIONAL TESTS
1. Friability - not more than 1.0% 2. Hardness - minimum 3 kg/cm square.
LIMITS
For test 3 & 4, limit as per IP-2007.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
160 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D05007
Quality Control Department
Drug Name : Pheneramine Maleate Tablets IP Page 1 of 1
Synonym : Pheneramine Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 1541-1542
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
69
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Related substances. 4. Uniformity of weight – Refer- G-TAB-002 5. Disintegration-Refer- G-TAB-004 6. Assay: limit-92.5-107.5% of the stated amount Pheneramine Maleate.
ADDITIONAL TESTS
1. Friability - Not more than 1.0% 2. Hardness - Minimum 3 kg/cm square.
LIMITS
For test 1 to 6, limit as per IP-2007.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D07002
Quality Control Department
Drug Name : Phenobarbitone Tablet IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 4, Page No. 1542
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
70
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Uniformity of Weight- Refer-G-TAB-002. 4. Disintegration- limit-30 minutes, Refer- G-TAB-004 5. Assay: limit- 92.5-107.5% of the stated amount of Phenobarbitone.
ADDITIONAL TESTS
1. Friability - Not more than 1.0% 2. Hardness - Minimum 3 kg/cm square.
LIMITS
For test 1 to 5, limit as per IP-2007.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D07004
Quality Control Department Drug Name : Phenytoin Sodium Tablets IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 3, Page No. 1555
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
71
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Related substances 4. Uniformity of weight – Refer- G-TAB-002 5. Disintegration-Refer- G-TAB-004 6. Assay: limit- 90.0-110.0% of the stated amount Phenytoin sodium.
ADDITIONAL TESTS
1. Friability - Not more than 1.0% 2. Hardness - Minimum 3 kg/cm square.
LIMITS
For test 1 to 6, limit as per IP-2007.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D05011
Quality Control Department
Drug Name : Prednisolone Tablets IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 3, Page No. 1583-1585
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
72
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Dissolution – Refer G-TAB -003 4. Related substances-HPLC 5. Uniformity of content -Refer- G-TAB-001 6. Assay: -90.0% to 110.0% of the stated amount of Prednisolone
ADDITIONAL TESTS
Friability - Not more than 1.0%
LIMITS
For test 1 to 6, limit as per IP-2007.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D13029 & D13030 Quality Control Department
Drug Name : Propranolol Tablets IP Page 1 of 1
Synonym : Propranolol Hydrochloride Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 3, Page No. 1610-1611
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
73
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Uniformity of Weight- Refer-G-TAB-002. 4. Dissolution – D value not less than 75.0% of the stated amount of
Propranolol Hydrochloride, Refer-G-TAB-003 5. Assay: - HPLC - limit not less than 92.5% and not more than 107.5% of
stated amount of Propranolol Hydrochloride.
ADDITIONAL TESTS
Friability - Not more than 1.0%
LIMITS
For test 1 to 5, limit as per IP-2007.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D20002
Quality Control Department
Drug Name : Ranitidine Hydrochloride Tablets IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 3, Page No. 1653-1654
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
74
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification- HPLC 3. Related substance-HPLC 4. Uniformity of weight – Refer -G-TAB-002 5. Disintegration Refer G-TAB-004 6. Assay: - limit 90.0% to 110.0% of the stated amount of Ranitidine.
ADDITIONAL TESTS
Leak test for strips - limit not more than 2%
LIMITS
For test 1 to 6, limit as per IP-2007.
LABELLING
The label states the strength in terms of the equivalent amount of Ranitidine.
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D17017
Quality Control Department
Drug Name : Risperidone Tablets USP Page 1 of 1
Synonym : Copy No. 1
Official Standards : US Pharmacopoeia 2008, Volume 3, Page No. 3197-3198
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
75
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification- HPLC 3. Dissolution – NLT -75% (Q) of the labelled amount of Risperidone.
Refer- P-267 4. Uniformity of dosage units Refer P. No. 363 5. Related compounds - HPLC 6. Assay: - limit 90.0% to 110.0% of the labelled amount of Risperidone.
ADDITIONAL TESTS
1. Friability - Not more than 1.0% 2. Hardness - Minimum 3 kg/cm square.
LIMITS
For test 1 to 6, limit as per USP-2008
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
160 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D03004
Quality Control Department
Drug Name : Salbutamol Sulphate Tablet IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 1689-1690
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
76
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Related substances. 4. Uniformity of Content- Refer-G-TAB-001 5. Disintegration- Refer- G-TAB-004 6. Assay: limit- 90.0-110.0% of the stated amount of Salbutamol.
ADDITIONAL TESTS
1. Friability - Not more than 1.0% 2. Hardness - Minimum 3 kg/cm square.
LIMITS
For test 1 to 6, limit as per IP-2007.
LABELLING
The label states the strength in terms of the equivalent amount of Salbutamol.
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D17019
Quality Control Department
Drug Name : Sertraline Tablets Page 1 of 1
Synonym : Copy No. 1
Official Standards :
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
77
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Uniformity of Weight- Refer- G-TAB-002. 4. Disintegration .Refer-G-TAB-004 5. Assay: - HPLC - Limit not less than 90.0% and not more than 110.0% of
stated amount of Sertraline.
ADDITIONAL TESTS
1. Friability - Not more than 1.0% 2. Hardness - Minimum 3 kg/cm square.
LIMITS
For test 3 and 4, limit as per IP-2007.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
120 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D07006 & D07010 Quality Control Department
Drug Name : Sodium Valporate Tablets IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 3, Page No. 1738
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
78
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Uniformity of Weight- Refer-G-TAB-002. 4. Disintegration – Refer G-TAB-004 5. Related substance – Gas chromatography 6. Assay: Limit-95.0-105.0% of the stated amount of Sodium Valporate.
ADDITIONAL TESTS
1. Friability - Not more than 1.0% 2. Hardness - Minimum 3 kg/cm square.
LIMITS
For test 1 to 6, limit as per IP-2007.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D19003
Quality Control Department
Drug Name : Spironolactone Tablets IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 3, Page No. 1471-1472
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
79
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Dissolution – D value not less than 70.0% of the stated amount of
Spironolactone. Refer-G-TAB-003 4. Uniformity of weight Refer- G-TAB-002 5. Assay: - HPLC - limit not less than 95.0% and not more than 105.0% of
stated amount of Spironolactone.
ADDITIONAL TESTS
1. Friability - Not more than 1.0% 2. Hardness - Minimum 3 kg/cm square.
LIMITS
For test 1 to 5, limit as per IP-2007.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D01015
Quality Control Department
Drug Name : Sulfasalazine Tablets BP Page 1 of 1
Synonym : Copy No. 1
Official Standards : British Pharmacopoeia 2009, Volume 3, Page No. 2985
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
80
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Salicylic acid and sulfa pyridine-HPLC 4. Related substance-HPLC-Refer Page No-2985 5. Uniformity of content- Refer-Page-2257 BP 6. Dissolution- Refer- Not less than 70% 7. Assay: limit- 95.0-105.0% of the stated amount of Sulfasalazine.
ADDITIONAL TESTS
1. Friability - Not more than 1.0% 2. Hardness - Minimum 3 kg/cm square.
LIMITS
For test 1 to 7, limit as per BP-2009.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D24027
Quality Control Department
Drug Name : Tamoxifen Tablets IP Page 1 of 1
Synonym : Tamoxifen Citrate Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 3, Page No. 1780-1781
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
81
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. E-isomer and Related substances 4. Uniformity of content - Refer- G-TAB-001 5. Disintegration – Refer G-TAB -004 6. Assay: - 90.0% to 110.0% of the stated amount of Tamoxifen.
ADDITIONAL TESTS
Friability - Not more than 1.0%
LIMITS
For test 1 to 6, limit as per IP-2007.
LABELLING
The label states the strength in terms of the equivalent amount of Tamoxifen.
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D03002
Quality Control Department
Drug Name : Theophylline and Etophylline Tablets Page 1 of 1
Synonym : Copy No. 1
Official Standards :
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
82
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Uniformity of Weight- Refer-G-TAB-002 4. Disintegration- Refer- G-TAB-004 5. Assay: limit- 90.0-110.0% of the stated amount of Theophylline and
Etophylline.
ADDITIONAL TESTS
1. Friability - Not more than 1.0% 2. Hardness - Minimum 3 kg/cm square.
LIMITS
For test 1 to 5, limit as per IP-2007.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D21019
Quality Control Department
Drug Name : Thyroxine Sodium Tablets IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 3, Page No. 1807-1808
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
83
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Uniformity of content - Refer- G-TAB-001 4. Disintegration – Refer G-TAB -004 5. Assay: - 90.0% to 110.0% of the stated amount of Thyroxine Sodium.
ADDITIONAL TESTS
Friability - Not more than 1.0%
LIMITS
For test 1 to 5, limit as per IP-2007.
LABELLING
The label states the strength in terms of the equivalent amount of anhydrous Thyroxine sodium.
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D01012
Quality Control Department
Drug Name : Tramadol Tablets Page 1 of 1
Synonym : Copy No. 1
Official Standards :
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
84
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Uniformity of weight - Refer- G-TAB-002 4. Disintegration –Refer-G-TAB-004 5. Assay: - HPLC - Limit not less than 90.0% and not more than 110.0% of
stated amount of Tramadol hydrochloride.
ADDITIONAL TESTS
1. Friability - not more than 1.0% 2. Hardness - minimum 3 kg/cm square.
LIMITS
For test 3 & 4, limit as per IP-2007.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
160 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D11001
Quality Control Department
Drug Name : Trihexyphenidyl Tablets IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 783-784
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
85
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification - HPLC. 3. Uniformity of Content -Refer- G-TAB-001 4. Disintegration – Refer G-TAB -004 5. Assay: - 90.0% to 110.0% of the stated amount of Trihexyphenidyl
Hydrochloride.
ADDITIONAL TESTS
Friability - Not more than 1.0%
LIMITS
For test 1 to 5, limit as per IP-2007.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D13007
Quality Control Department
Drug Name : Verapamil Tablets IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 3, Page No. 1854
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
86
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Related substances 4. Uniformity of weight Refer- G-TAB-002 5. Disintegration –Refer-G-TAB-004 6. Assay: - Limit not less than 92.5% and not more than 107.5% of stated
amount of Verapamil Hydrochloride.
ADDITIONAL TESTS
Friability - Not more than 1.0%
LIMITS
For test 1 to 6, limit as per IP-2007.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D22002 & D22004 Quality Control Department
Drug Name : Vitamin B Complex Tablets NFI (Strong) Page 1 of 1
Synonym : Copy No. 1
Official Standards : NFI
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
87
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification- HPLC 3. Uniformity of weight – Refer G-TAB-002 4. Disintegration – Refer G-TAB-004 5. Assay: - Limits 90.0% to 110.0% of the stated amount.
ADDITIONAL TESTS
1. Friability - Not more than 1.0% 2. Hardness - Minimum 3 kg/cm square.
LIMITS
IP-2007 & NFI
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
88
KKEE
RRAA
LLAA
MM
EEDD
II CCAA
LL
SSEE
RRVV
II CCEE
SS
CCOO
RRPP
OORR
AATT
II OONN
LL
TTDD
CCAAPPSSUULLEESS
QQuuaalliittyy CCoonnttrrooll MMaannuuaall FFoorr
DDrruuggss AAnndd SSuupppplliieess
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D02004 & D02005 Quality Control Department
Drug Name : Amoxicillin Capsules IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 719
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
89
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Identification 3. Uniformity of weight- Refer-G-CAP-001 4. Dissolution- Refer- G-CAP-004 5. Assay: limit-90.0-110.0% of the stated amount of Amoxicillin
ADDITIONAL TESTS
Leak test
LIMITS
For test 1 to 5. Limit as per IP-2007
LABELLING
The label states the quantity of the active ingredient in terms of the equivalent amount of Amoxicillin
QUANTITY REQUIRED FOR ANALYSIS
100 numbers
SHELF LIFE
Minimum 2 year
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D02007
Quality Control Department
Drug Name : Ampicillin Capsules IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 729
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
90
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Identification 3. Uniformity of weight- Refer-G-CAP-001 4. Dissolution-Refer- G-CAP-004 5. Assay: limit-92.5-107.5% of the stated amount of
Ampicillin ADDITIONAL TESTS Leak test LIMITS For tests 1 to 5, Limit as per IP-2007 LABELLING
The label states the strength in terms of the equivalent amount of Ampicillin (when Ampicillin trihydrate is used)
QUANTITY REQUIRED FOR ANALYSIS 100 numbers SHELF LIFE Minimum 2 year
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D10002
Quality Control Department
Drug Name : Clofazimine Capsules IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 948
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
91
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Identification 3. Uniformity of weight- Refer-G-CAP-001 4. Disintegration-Refer- G-CAP-003 5. Assay: limit-95.0-105.0% of the stated amount of Clofazimine.
ADDITIONAL TESTS
Leak test
LIMITS
For tests 1 to 5, Limit as per IP-2007.
LABELLING
QUANTITY REQUIRED FOR ANALYSIS
100 numbers
SHELF LIFE
Minimum 2 year
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D02006
Quality Control Department
Drug Name : Cloxacillin Capsules IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 960-961
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
92
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Identification 3. Uniformity of weight- Refer-G-CAP-001 4. Dissolution-Refer- G-CAP-004 5. Assay: limit-92.5-107.5% of the stated amount of Cloxacillin
ADDITIONAL TESTS
Leak test
LIMITS
For tests 1 to 5, Limit as per IP-2007
LABELLING
The label states the quantity of the active ingredient in terms of the equivalent amount of Cloxacillin.
QUANTITY REQUIRED FOR ANALYSIS
100 numbers
SHELF LIFE
Minimum 2 year
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D02014
Quality Control Department
Drug Name : Doxycycline Capsules IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 1063-1064
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
93
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Identification 3. Light absorbing impurities-absorbance of the filtrate at about 490nm is not
greater than 0.2 when calculated with the reference to the dried contents of the capsule.
4. Related substance-HPLC 5. Loss on drying-not more than 8.5% determined on 0.5grams of the
contents of the capsules by drying in an oven at 105°c for 2 hours. 6. Uniformity of weight- refer-G-CAP001 7. Disintegration-,refer- G-CAP-003 8. Assay: limit-90.0-120.0% of the stated amount of Doxycycline.
ADDITIONAL TESTS
Leak test
LIMITS
For tests 1 to 8, Limit as per IP-2007.
LABELLING
The label states the strength in terms of the equivalent amount of Doxycycline.
QUANTITY REQUIRED FOR ANALYSIS
100 numbers
SHELF LIFE
Minimum 2 year
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D017008
Quality Control Department
Drug Name : Fluoxetine Capsules USP Page 1 of 1
Synonym : Copy No. 1
Official Standards : US Pharmacopoeia 2008, Volume 2, Page No. 2201
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
94
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Identification 3. Uniformity of dosage units 4. Dissolution- Q- value NLT 80.0% of the labeled amount of Fluoxetine
Note: For delayed release capsules-Acid stage-NMT 10.0% of the labeled amount of Fluoxetine; Buffer stage-NLT 75.0% (Q) of the labeled amount of Fluoxetine.
5. Chromatographic purity 6. Assay: limit-90.0-110.0% of the labeled amount of Fluoxetine
ADDITIONAL TESTS
Leak test
LIMITS
For tests 1 to 6, Limit as per USP-2008.
LABELLING
QUANTITY REQUIRED FOR ANALYSIS
200 numbers
SHELF LIFE
Minimum 2 year
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D24023
Quality Control Department
Drug Name : Hydroxy urea Capsules USP Page 1 of 1
Synonym : Copy No. 1
Official Standards : US Pharmacopoeia 2008, Volume 2, Page No. 2361-2362
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
95
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Identification 3. Dissolution – D value 80.0% (Q) of the labeled amount of Hydroxy urea. 4. Uniformity of dosage units 5. Assay: -90.0% to 110.0% of the stated amount of Hydroxy urea.
ADDITIONAL TESTS
Leak test
LIMITS
For tests 1 to 5, Limit as per USP-2008.
LABELLING
QUANTITY REQUIRED FOR ANALYSIS
120 numbers
SHELF LIFE
Minimum 2 year
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D13006
Quality Control Department
Drug Name : Nifedipine Capsules IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 3, Page No. 1443
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
96
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Identification 3. Uniformity of content- Refer-G-CAP-002 4. Disintegration- Limit- NMT 30 minutes, Refer- G-CAP-003 5. Assay: limit-90.0-110.0% of the stated amount of Nifedipine.
ADDITIONAL TESTS
Leak test
LIMITS
For tests 1 to 5, Limit as per IP-2007.
LABELLING
QUANTITY REQUIRED FOR ANALYSIS
100 numbers
SHELF LIFE
Minimum 2 year
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D20004
Quality Control Department
Drug Name : Omeprazole Capsules IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 3, Page No. 1474-1475
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
97
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Identification 3. Uniformity of weight- Refer-G-CAP-001 4. Dissolution- D- value NLT 70.0%.Refer- G-CAP-004 5. Loss on drying- Limit-NMT 3.0% 6. Assay: limit-90.0-110.0% of the stated amount of Omeprazole
ADDITIONAL TESTS
Leak test
LIMITS
For tests 1 to 6, Limit as per IP-2007.
LABELLING
QUANTITY REQUIRED FOR ANALYSIS
200 numbers
SHELF LIFE
Minimum 2 year
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D22005
Quality Control Department
Drug Name : Vitamin A and D Capsules IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 3, Page No. 1863
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
98
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Identification 3. Uniformity of weight- Refer-G-CAP-001 4. Disintegration-Refer-G-CAP-003 5. Assay: limit-90.0-110.0% of the stated number of units of Vitamin A and D
ADDITIONAL TESTS
Leak test
LIMITS
For tests 1 to 5, Limit as per IP-2007.
LABELLING
The label states the number of units of Vitamin A and Vitamin D per capsules.
QUANTITY REQUIRED FOR ANALYSIS
100 numbers
SHELF LIFE
Minimum 2 year
99
KKEE
RRAA
LLAA
MM
EEDD
II CCAA
LL
SSEE
RRVV
II CCEE
SS
CCOO
RRPP
OORR
AATT
II OONN
LL
TTDD
OORRAALL LLIIQQUUIIDDSS,,SSOOLLUUTTIIOONNSS&&
PPOOWWDDEERRSS
QQuuaalliittyy CCoonnttrrooll MMaannuuaall FFoorr
DDrruuggss AAnndd SSuupppplliieess
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D02032 & D02033 Quality Control Department
Drug Name : Amoxycillin Dry Syrup IP Page 1 of 1
Synonym : Amoxycillin oral suspension Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 721
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
100
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Identification 3. pH-limit-4.0 to 7.0 4. Uniformity of weight- Refer-G-ORP-002 5. Assay: limit-90.0%-120.0% of the stated amount of Amoxycillin.
When stored at the temperature and for the period stated on the label during which the constituted suspension may be expected to be satisfactory for use, it contains NLT 80.0 % of the stated amount of Amoxycillin.
ADDITIONAL TESTS
Nil
LIMITS
For test 1 to 5, limit as per IP-2007.
LABELLING
The label states 1) the quantity of active ingredient in terms of the equivalent amount of Amoxycillin; 2) the temperature of storage and the period during which the constituted suspension may be expected to be satisfactory for use.
QUANTITY REQUIRED FOR ANALYSIS
50 numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D26001
Quality Control Department
Drug Name : Benedicts Reagent Page 1 of 1
Synonym : Copy No. 1
Official Standards : KMSCL In-house Method.
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
101
TESTS AS PER OFFICIAL MONOGRAPH
1. Description - Blue solution 2. Identification - Gives positive results for the presence of Sodium, Copper and
Sulphate. Qualitative Analysis
Standard Benedicts Reagent:- Solution-1:- Dissolve 173 gram of sodium citrate and 100 gram sodium carbonate in about 800 ml water. Heat to dissolve the salts and filter if necessary. Solution -2:- Dissolve17.3 gram copper sulphate in about 100 ml water. Mix solutions 1 and 2 with stirring and make up the volume to 1000 ml with water. Benedicts Test. (Qualitative):- Standard Benedicts solution: - To 2ml of standard Benedict’s reagent, add 5 drops (about 1 ml) of the test solution and add 3 drops of Methylene Blue indicator. Boil for 10 minutes in a water bath. Cool the solution. Observation: - Red or green colored precipitate / solution is formed. Sample Benedicts solution: - To 2 ml of Benedict’s reagent, add 5 drops (about 1ml) of the test solution and add 3 drops of Methylene Blue indicator. Boil for 10 minutes in a water bath. Cool the solution Observation: - Red or green colored precipitate / solution is formed. (Note: - Test solution: 1 gram of Dextrose anhydrous dissolved in 100 ml water.)
Quantitative Analysis
Standard Benedicts solution: - To 20 ml of standard Benedicts reagent, add three drops of Methylene Blue solution. Boil and titrate with 1.0% w/v solution of anhydrous Dextrose. End point - Brick red color. Sample Benedict’s solution: - To 20 ml of sample Benedict’s reagent, add three drops of Methylene Blue solution. Boil and titrate with 1.0% w/v solution of anhydrous Dextrose. End point - Brick red color.
QUANTITY REQUIRED FOR ANALYSIS 2 x 500ml. SHELF LIFE Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D02022
Quality Control Department
Drug Name : Cephalexin Oral Suspension (Dry) IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 888
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
102
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Identification 3. Uniformity of weight- Refer-G-ORP-002 4. Assay: limit-90.0-120.0% of the stated amount of Cephalexin.
ADDITIONAL TESTS
Nil
LIMITS
For test 1 to 4, limit as per IP-2007.
LABELLING
The label states the strength in terms of the equivalent amount of anhydrous Cephalaxin.
QUANTITY REQUIRED FOR ANALYSIS
100 numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D25010
Quality Control Department
Drug Name : Chlorhexidine Gluconate 2.5% v/v with Ethyl Alcohol 70.0% v/v Solution Page 1 of 1
Synonym : Copy No. 1
Official Standards :
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
103
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Identification 3. Ethanol content 4. Weight/ml 5. Assay: -90.0% - 110.0% of the stated amount.
ADDITIONAL TESTS
Nil
LIMITS
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
2 Numbers.
SHELF LIFE
Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D25001
Quality Control Department
Drug Name : Chlorhexidine / Cetrimide Solution Page 1 of 1
Synonym : Copy No. 1
Official Standards :
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
104
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Identification 3. Weight/ml 4. Assay: -90.0% - 110.0% of the stated amount.
ADDITIONAL TESTS
Nil
LIMITS
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
2 Numbers.
SHELF LIFE
Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D25005 & D25006 Quality Control Department
Drug Name : Chloroxylenol solution BP Page 1 of 1
Synonym : Copy No.
Official Standards : British Pharmacopoeia 2009, Volume 3, Page No. 2401-2402
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
105
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Identification 3. Ethanol content-Limit16.0 to 21.0%v/v 4. Organic stabilizers. 5. Non-volatile matter 6. Assay: - GC- 4.75 to 5.25%w/v of Chloroxylenol.
ADDITIONAL TESTS
LIMITS
For tests 1 to 6, limit as per BP-2009.
LABELLING
1. The label states the names of any added anti-microbial preservatives (p.2222) 2. The date after which the solution is not intended to be used. 3. The conditions under which it should be stored. 4. The label indicates the pharmaceutical form as ‘cutaneous solution’.
QUANTITY REQUIRED FOR ANALYSIS
2 Numbers.
SHELF LIFE
Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D02002
Quality Control Department
Drug Name : Co-trimoxazole Oral Suspension IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 3, Page No. 1832-1833
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
106
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Identification 3. Uniformity of volume- Refer-G-ORA-002 4. pH-limit-5.0 to 6.5 5. Assay: limit 90.0%-110.0% of the stated amount of Trimethoprim and
Sulphamethoxazole
ADDITIONAL TESTS
Nil
LIMITS
For test 1 to 5, limit as per IP-2007.
LABELLING
The label states 1) the content of Trimethoprim and of Sulphamethoxazole in each 5 ml of the suspension 2) that the contents should be shaken before use; 3) that a suspension containing 40 mg of Trimethoprim and 200mg of Sulphamethoxazole in 5ml is meant for pediatric use.
QUANTITY REQUIRED FOR ANALYSIS
100 numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D20010
Quality Control Department
Drug Name : Dicyclomine Oral Solution IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 1691
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
107
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Identification 3. Uniformity of volume- Refer-G-ORA-002 4. Assay: limit-90.0-110.0% of the stated amount of Dicyclomine
Hydrochloride.
ADDITIONAL TESTS
Nil
LIMITS
For test 1 to 4, limit as per IP-2007.
LABELLING
QUANTITY REQUIRED FOR ANALYSIS
50 numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D08004
Quality Control Department
Drug Name : Diethylcarbamazine Citrate Suspension Page 1 of 1
Synonym : Copy No. 1
Official Standards : KMSCL In-house Method
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
108
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Identification 3. Uniformity of volume- Refer-G-ORA-002 4. Microbial limits-(as per IP -2007)-Total Bacterial counts-NMT 100 CFU/ML
Pseudomonas aeuruginosa-should be absent. Total yeast and mould count-NMT 100 CFU/MG Escherichia coli-should be absent. Staphylococcus aureus-should be absent Salmonella species-should be absent
5. Assay: limit-90.0-110.0% of the stated amount of Diethylcarbamazine citrate.
ADDITIONAL TESTS
Nil
LIMITS
For test 1 to 5, limit as per IP-2007 & KMSCL In-house method.
LABELLING
QUANTITY REQUIRED FOR ANALYSIS
50 numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D20014
Quality Control Department
Drug Name : Formaldehyde Solution IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia.
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
109
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Weight per ml at 25°c 3. Assay-Limit 34.0 to 37.0 % w/v of Formaldehyde.
ADDITIONAL TESTS
LIMITS
For test 1 to 3, limit as per IP.
LABELLING
QUANTITY REQUIRED FOR ANALYSIS
2 x 500 ml.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D14010
Quality Control Department
Drug Name : Gamma Benzene Hexachloride Solution USP Page 1 of 1
Synonym : Lindane Lotion Copy No. 1
Official Standards : US Pharmacopeia.
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
110
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Identification 3. pH- Limit 6.5 to 8.5 4. Weight/ml 5. Uniformity of Volume- Refer-G-ORA-002 6. Assay: - Limits 0.9 %w/v to 1.1 % w/v of Gamma Benzene Hexachloride.
ADDITIONAL TESTS
Nil
LIMITS
For tests 1 to 6, limit as per USP.
LABELLING
QUANTITY REQUIRED FOR ANALYSIS
4 numbers.
SHELF LIFE
Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D25007
Quality Control Department
Drug Name : Glutaraldehyde Solution BP Page 1 of 1
Synonym : Copy No. 1
Official Standards : British Pharmacopoeia 2009, Volume 3, Page No. 2629
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
111
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Identification 3. Ethanol content- 50.0 to 60.0% v/v. 4. Assay: - 9.2 to 10.5 %w/v of Glutaraldehyde.
ADDITIONAL TESTS
Particulate matter -sample should be clear and free from particles when observed on visual inspection
LIMITS
For tests 1 to 4, limit as per BP-2009.
LABELLING
The label states (1) the date after which the solution is not intended to be used. (2) the condition under which it should be stored.
QUANTITY REQUIRED FOR ANALYSIS
2 Numbers.
SHELF LIFE
Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D14021
Quality Control Department
Drug Name : Glycerin IP Page 1 of 1
Synonym : Glycerol Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 3, Page No. 1169
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
112
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Identification 3. Appearance of solution 4. Acidity or Alkalinity 5. Heavy metals 6. Iron 7. Chlorides 8. Sulphates 9. Aldehydes and reducing substances 10. Ester 11. Ethylene glycol, diethylene glycol and related substances 12. Sugars 13. Sulphated ash 14. Water 15. Assay-Limit 98.0 to 110.0% of Glycerin calculated on the anhydrous basis.
ADDITIONAL TESTS Nil
LIMITS
For test 1 to 15, limit as per IP-2007.
LABELLING
QUANTITY REQUIRED FOR ANALYSIS
2 Numbers.
SHELF LIFE
Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D04002
Quality Control Department
Drug Name : Halothane USP Liquid Page 1 of 1
Synonym : Copy No. 1
Official Standards : US Pharmacopoeia 2008, Volume 2, Page No. 2319
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
113
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Identification-IR 3. Specific gravity-1.872 TO 1.877 AT 20°C - p.no-351 of USP vol-1 4. Distilling range-p.no-274 of USP vol-1 5. Refractive index-1.369 and 1.371 at 20°c- p.no-351 of USPvol-1 6. Acidity or alkalinity 7. Water-not more than 0.03 %- p.no-370 of USP vol-1 8. Limit of non volatile residue-not exceeding 1.0 mg 9. Chlorides and bromides- 10. Thymol content 11. Chromatographic purity-GC –Halothane contains not less than 0.008% and
not more than 0.0121 % of Thymol, by weight as a stabilizer.
ADDITIONAL TESTS Nil
LIMITS
For test 1 to 11, limit as per USP-2008.
LABELLING
The label states the strength in terms of the equivalent amount of anhydrous Cephalaxin.
QUANTITY REQUIRED FOR ANALYSIS
10 numbers.
SHELF LIFE
Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D25003 & D25016 Quality Control Department
Drug Name : Hydrogen peroxide Solution IP 20.0%w/v Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 1203
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
114
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Identification 3. Acidity 4. Organic stabilizers. 5. Non-volatile matter 6. Assay - Limit5.0%w/v to 7.0%w/v of Hydrogen peroxide, corresponding to
about 20 times its volume of available oxygen.
ADDITIONAL TESTS
Nil
LIMITS
For test 1 to 6, limit as per IP-2007.
LABELLING
The label states whether or not the solution contains a stabilizing agent.
QUANTITY REQUIRED FOR ANALYSIS
4 Numbers.
SHELF LIFE
Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D20013
Quality Control Department
Drug Name : Mixture Carminative Concentrate Page 1 of 1
Synonym : Copy No. 1
Official Standards :
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
115
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Identification 3. Alcohol content-Limit, 20.0 to 26.0%v/v as per label claim. 4. Assay: limit-90.0-110.0% of the stated amount of Sodium bicarbonate.
ADDITIONAL TESTS
LIMITS
LABELLING
Dilution should be stated.
QUANTITY REQUIRED FOR ANALYSIS
2 x 500 ml.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D25009
Quality Control Department
Drug Name : Non Oxylenol Surfactant Based Iodine Solution Page 1 of 1
Synonym : Copy No. 1
Official Standards : KMSCL In-house Method.
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
116
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Identification–for Iodine 3. pH-Limit 2.5 to 3.5 4. Assay: limit-85.0-120.0% of the stated amount of available Iodine.
ADDITIONAL TESTS
LIMITS
For test 1 to 4, limit as per KMSCL In-house method.
LABELLING
QUANTITY REQUIRED FOR ANALYSIS
2x 500 ml.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D20011
Quality Control Department
Drug Name : ORS Powder IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 3, Page No. 1475-1476
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
117
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Identification 3. Uniformity of weight-Refer, G-ORP-002 4. Seal test-(only for sachets). 5. Assay-ORS contains NLT 90.0% and NMT 110.0% of the stated amount of
Dextrose (anhydrous) or Dextrose monohydrate as appropriate and of the requisite amounts of sodium, potassium, chloride and citrate calculated from the stated amount of the relevant constituents.
ADDITIONAL TESTS
Nil
LIMITS
For test 1 to 5, limit as per IP-2007.
LABELLING
The Label should meet the requirements as stated in IP (1 to 7)
QUANTITY REQUIRED FOR ANALYSIS
100 numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D25008
Quality Control Department
Drug Name : Orthothaladehyde Solution Page 1 of 1
Synonym : Copy No. 1
Official Standards : KMSCL In-house Method.
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
118
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Identification 3. pH-Limit 7.0 to 8.0 4. Assay: limit-90.0-110.0% of the stated amount of Orthothaladehyde.
ADDITIONAL TESTS
Nil
LIMITS
For test 1 to 4, limit as per KMSCL In-house method
LABELLING
QUANTITY REQUIRED FOR ANALYSIS
1x 5 litre.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D01003
Quality Control Department
Drug Name : Paracetamol Syrup IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 3, Page No. 1515-1516
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
119
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Identification 3. 4-amino phenol 4. Uniformity of volume- refer-G-ORA-002 5. Particulate matter -sample should be clear and free from particles when
observed on visual inspection 6. Assay: limit 95.0-105.0% of the stated amount of Paracetamol.
ADDITIONAL TESTS
Nil
LIMITS
For test 1, 2, 3 and 6, limit as per IP-2007
LABELLING
Nil.
QUANTITY REQUIRED FOR ANALYSIS
50 numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D08016
Quality Control Department
Drug Name : Piperazine Citrate Syrup IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 3, Page No. 1515-1516
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
120
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Identification 3. Uniformity of volume- Refer-G-ORA-002 4. Assay: limit-92.5-107.5% of the stated amount of Piperazine hydrate.
ADDITIONAL TESTS
Particulate matter -sample should be clear and free from particles when observed on visual inspection
LIMITS
For test 1 to 4, limit as per IP-2007.
LABELLING
The label states the strength in terms of the equivalent amount of Piperazine hydrate.
QUANTITY REQUIRED FOR ANALYSIS
50 numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D14011 & D14019 Quality Control Department
Drug Name : Povidone Iodine Solution IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 3, Page No. 1578-1579
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
121
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Identification 3. pH-Limit-3.0 to 6.5 4. Ethanol (if present)-Limit, 90.0 to 110.0 % of the stated amount of Ethanol. 5. Assay-Limit, NLT 85.0 % and NMT 120.0 % of the stated amount of Iodine.
ADDITIONAL TESTS
Nil
LIMITS
For test 1 to 5, limit as per IP-2007.
LABELLING
The label states the quantities of Iodine and Ethanol (if present) as % w/v.
QUANTITY REQUIRED FOR ANALYSIS
2 x 500 ml.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D03006
Quality Control Department
Drug Name : Salbutamol Nebuliser Solution BP Page 1 of 1
Synonym : Salbutamol Copy No. 1
Official Standards : British Pharmacopoeia 2009, Volume 3, Page No. 2946
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
122
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Identification 3. Acidity (pH-3 to 5)-refer P.A225 4. Related substance-HPLC 5. Salbutamol ketone-HPLC 6. Assay: limit-95.0-105.0% of the stated amount of Salbutamol.
ADDITIONAL TESTS
Nil
LIMITS
For test 1 to 6, limit as per BP-2009.
LABELLING
1. Not to be taken by mouth 2. Label states the quantity of active ingredients in terms of the equivalent
amount of Salbutamol. 3. The date after which the solution for nebulisation is not intended to be
used.
QUANTITY REQUIRED FOR ANALYSIS
30 numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D03005
Quality Control Department
Drug Name : Salbutamol Syrup IP Page 1 of 1
Synonym : Salbutamol Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 3, Page No. 1691
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
123
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Identification 3. pH-3.4 to4.5 4. Uniformity of volume- Refer-G-ORA-002 5. Assay: limit-90.0-110.0% of the stated amount of Salbutamol.
ADDITIONAL TESTS
Nil
LIMITS
For test 1 to 5, limit as per IP-2007.
LABELLING
The label states the strength in terms of the equivalent amount of Salbutamol.
QUANTITY REQUIRED FOR ANALYSIS
240 numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D20015
Quality Control Department
Drug Name : Syrup Lactulose USP Page 1 of 1
Synonym : Lactulose Solution Copy No. 1
Official Standards : US Pharmacopeia 2008, Volume 2, Page No. 2497
124
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Identification 3. Microbial limits- Total bacterial count does not exceed 100 CFU/gram of
Lactulose and the test for Salmonella species and Escherichia coli are negative.
4. pH-Limit-2.5 to 6.5 5. Related compounds. 6. Volume in container. 7. Assay: NLT 90.0% and NMT 110.0%w/w of the labeled amount of
Lactulose.
ADDITIONAL TESTS
Nil
LIMITS
For test 1 to 8, limit as per USP-2008.
LABELLING
QUANTITY REQUIRED FOR ANALYSIS
50 numbers.
SHELF LIFE
Minimum 18 months.
125
KKEE
RRAA
LLAA
MM
EEDD
II CCAA
LL
SSEE
RRVV
II CCEE
SS
CCOO
RRPP
OORR
AATT
II OONN
LL
TTDD
GGEELLSS,,CCRREEAAMMSS,,OOIINNTTMMEENNTTSS,,LLIINNIIMMEENNTTSS,,LLOOTTIIOONNSS,,
PPEESSSSEERRIIEESS
QQuuaalliittyy CCoonnttrrooll MMaannuuaall FFoorr
DDrruuggss AAnndd SSuupppplliieess
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D09003
Quality Control Department
Drug Name : Acyclovir Cream BP 5 %w/w Page 1 of 1
Synonym : Copy No. 1
Official Standards : British Pharmacopoeia 2009, Volume 3, Page No. 2268
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
126
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Identification 3. Guanine 4. Assay: NLT 95.0% and NMT 105.0%w/w of the stated amount of Acyclovir.
ADDITIONAL TESTS
Uniformity of weight.
LIMITS
For tests 1 to 4, Limit as per BP-2009.
LABELLING
The label states (1) the date after which the cream is not intended to be used; (2) the conditions under which the cream should be stored.
QUANTITY REQUIRED FOR ANALYSIS
40 x 5 grams
SHELF LIFE
Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D14006
Quality Control Department
Drug Name : Benzyl Benzoate Application IP 25% w/v Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 790
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
127
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Identification 3. Assay: NLT 22.5% and NMT 27.5%w/w of Benzyl benzoate.
ADDITIONAL TESTS
Nil
LIMITS
For tests 1 to 3, Limit as per IP-2007.
LABELLING
The label states that the contents should be shaken before use.
QUANTITY REQUIRED FOR ANALYSIS
2x 500 ml
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D14009
Quality Control Department
Drug Name : Betamethasone Valerate Cream USP 1%w/w Page 1 of 1
Synonym : Copy No. 1
Official Standards : US Pharmacopeia 2008, Volume 1 & 2, Page No. 1524-1525
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
128
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Identification 3. Microbial limits-refer page no-71 4. Minimum fill-Refer page no-298 5. Assay: NLT 90.0% and NMT 110.0%w/w of the labeled amount of
Betamethasone.
ADDITIONAL TESTS
Nil
LIMITS
For tests 1 to 5, Limit as per USP-2008.
LABELLING
QUANTITY REQUIRED FOR ANALYSIS
60 x 5 gram tubes.
SHELF LIFE
Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D14014
Quality Control Department
Drug Name : Calamine Lotion IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 835
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
129
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Identification 3. Microbial contamination
ADDITIONAL TESTS
Nil
LIMITS
For tests 1 to 3, Limit as per IP-2007.
LABELLING
The label states (1) the concentration of Calamine and Zinc oxide in the preparation; (2) that the preparation is intended for external use only; (3) that the contents should be shaken before use; (4)the conditions under which the preparation should be stored.
QUANTITY REQUIRED FOR ANALYSIS
2X500 ml.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D15010
Quality Control Department
Drug Name : Chloramphenicol Applicaps Page 1 of 1
Synonym : Copy No. 1
Official Standards : KMSCL In-house Method & Indian Pharmacopoeia 2007
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
130
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Identification 3. Uniformity of weight-Refer-G-EYO-001 4. Sterility-Refer-G-EYO-003 5. Particle size-Refer-G-EYO-002 6. Assay: NLT 90.0% and NMT 120.0% of the stated amount of
Chloramphenicol
ADDITIONAL TESTS
Nil
LIMITS
For tests 1 to 6, Limit as per KMSCL In-house method and IP-2007.
LABELLING
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers
SHELF LIFE
Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D15003
Quality Control Department
Drug Name : Ciprofloxacin Eye Ointment USP Page 1 of 1
Synonym : Ciprofloxacin Ophthalmic Ointment Copy No. 1
Official Standards : US Pharmacopoeia 2008, Volume 2, Page No. 3292
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
131
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Identification 3. Sterility 4. Minimum fill-Refer page no-298 5. Metal particles 6. Assay: NLT 90.0% and NMT 110.0%w/w of the labeled amount of
Ciprofloxacin.
ADDITIONAL TESTS
Nil
LIMITS
For tests 1 to 6, Limit as per USP-2008.
LABELLING
QUANTITY REQUIRED FOR ANALYSIS
60 tubes.
SHELF LIFE
Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D08007
Quality Control Department
Drug Name : Clotrimazole Cream IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 957-958
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
132
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Identification 3. Chlorotritanol 4. Uniformity of weight – Refer- G-CRE-001 5. Sterility (when the cream is labeled as ‘sterile’) Refer-G-CRE-002 6. Assay: -95.0% - 105.0% of the stated amount of Clotrimazole
ADDITIONAL TESTS
Nil
LIMITS
For tests 1 to 6, Limit as per IP-2007.
LABELLING
The label state (1) that the cream is sterile, where necessary, (2) the name and concentration of any antimicrobial preservative (3) The storage conditions.
QUANTITY REQUIRED FOR ANALYSIS
40 numbers
SHELF LIFE
Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D14007
Quality Control Department
Drug Name : Glycerin Magsulf BPC Page 1 of 1
Synonym : Copy No. 1
Official Standards : BPC 1963
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
133
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Identification 3. Assay: -Limits:-magnesium sulphate-36.0 to 41.0% w/w Phenol-0.45 to 0.55 %w/w
ADDITIONAL TESTS
Nil
LIMITS
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
50 numbers
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D04003
Quality Control Department
Drug Name : Lignocaine HCl Gel IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 1301-1302
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
134
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Identification 3. Uniformity of weight-Refer- G-GEL-001 4. pH- limit 6.0 to 7.0 5. 2, 6, dimethyl aniline. 6. Sterility- Refer-G-INJ-005 7. Assay: limit-95.0-105.0% of the stated amount of Lignocaine Hcl.
ADDITIONAL TESTS
Nil
LIMITS
For tests 1 to 7, Limit as per IP-2007.
LABELLING
The label states (1) that the content are sterile (2) the strength in terms of the equivalent amount of anhydrous Lignocaine HCl (3) that any of the gel not used in a single application should be discarded
QUANTITY REQUIRED FOR ANALYSIS
100 numbers
SHELF LIFE
Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D14008
Quality Control Department
Drug Name : Povidone Iodine Ointment USP Page 1 of 1
Synonym : Copy No. 1
Official Standards : US Pharmacopeia 2008, Volume 1 & 3, Page No. 3050
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
135
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Identification 3. Minimum fill-Refer page no-298 4. pH-Limit-1.5 to 6.5 5. Assay: NLT 85.0% and NMT 120.0%w/w of the labeled amount of Iodine.
ADDITIONAL TESTS
Nil
LIMITS
For tests 1 to 5, Limit as per USP-2008.
LABELLING
QUANTITY REQUIRED FOR ANALYSIS
60 tubes.
SHELF LIFE
Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D16006
Quality Control Department
Drug Name : Povidone Iodine Vaginal Pesseries Page 1 of 1
Synonym : Copy No. 1
Official Standards : KMSCL In-house Method.
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
136
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Identification- HPLC 3. Uniformity of weight – Refer G-PES-002 4. Disintegration – Refer G-PES-003 5. Assay: -Limits 85.0% to 120.0% of the stated amount of available Iodine.
ADDITIONAL TESTS
Nil
LIMITS
For tests 1 to 5, Limit as per KMSCL In-house method.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D14004
Quality Control Department
Drug Name : Salicylic acid Ointment BP Page 1 of 1
Synonym : Copy No. 1
Official Standards : British Pharmacopoeia 2009, Volume 3, Page No. 2950
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
137
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Identification 3. Assay: NLT 1.9% and NMT 2.1%w/w of Salicylic acid.
ADDITIONAL TESTS
LIMITS
For tests 1 to 3, Limit as per BP-2009.
LABELLING
The label states (1) the date after which the ointment is not intended to be used; (2) the conditions under which the ointment should be stored.
QUANTITY REQUIRED FOR ANALYSIS
40 x 5 grams
SHELF LIFE
Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D14001
Quality Control Department
Drug Name : Silversulphadiazine Cream USP Page 1 of 1
Synonym : Copy No. 1
Official Standards : US Pharmacopeia 2008, Volume 1 & 3, Page No. 3292
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
138
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Identification 3. Microbial limits. -Total count does not exceed 23 CFU per gram.-Refer
page no-71 4. Minimum fill-Refer page no-298
pH-Limit-4.0 to 7.0 5. Assay: NLT 90.0% and NMT 110.0%w/w of the labeled amount of Silver
sulphadiazine.
ADDITIONAL TESTS
Nil
LIMITS
For tests 1 to 6, Limit as per USP-2008.
LABELLING
QUANTITY REQUIRED FOR ANALYSIS
60 tubes.
SHELF LIFE
Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D14013
Quality Control Department
Drug Name : Turpentine Liniment IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 1966.
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
139
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Refractive index-Limit 1.4710 to 1.4714 3. Assay: 63.0 to 70.0 % v/w of Volatile oil and Camphor.
ADDITIONAL TESTS
Nil
LIMITS
For tests 1 to 3, Limit as per IP-1966.
LABELLING
QUANTITY REQUIRED FOR ANALYSIS
2 x 500 ml.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D14005
Quality Control Department
Drug Name : Whitfield’s Ointment IP Page 1 of 1
Synonym : Compound Benzoic acid Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 785-786
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
140
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Identification 3. Uniformity of weight-Refer- G-OIN-001 4. Assay: NLT 5.7% and NMT 6.3%w/w of Benzoic acid and NLT 2.85% and
NMT 3.15 %w/w of Salicylic acid.
ADDITIONAL TESTS
Nil
LIMITS
For tests 1 to 4, Limit as per IP-2007.
LABELLING
QUANTITY REQUIRED FOR ANALYSIS
40 x 15 grams
SHELF LIFE
Minimum 18 months.
141
KKEE
RRAA
LLAA
MM
EEDD
II CCAA
LL
SSEE
RRVV
II CCEE
SS
CCOO
RRPP
OORR
AATT
II OONN
LL
TTDD
EEYYEE//EEAARR//NNAASSAALL DDRROOPPSS
QQuuaalliittyy CCoonnttrrooll MMaannuuaall FFoorr
DDrruuggss AAnndd SSuupppplliieess
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D15007
Quality Control Department
Drug Name : Betamethasone Eye Drops IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 800-801
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
142
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Identification 3. pH-Limit, 7.0 to 8.5 4. Uniformity of volume. Refer-G-EAR-001. 5. Particle size (applicable to eye drops that are suspension). Refer-G-EAR-002. 6. Sterility.Refer-G-EAR-003 7. Assay: limit-90.0-110.0% of the stated amount of Betamethasone Sodium
Phosphate.
ADDITIONAL TESTS
Nil
LIMITS
For test 1 to 7, limit as per IP-2007.
LABELLING
The label states; 1. the names and concentrations in % or weight or volume/ml of the active
ingredients, 2. the names and concentrations of any added anti-microbial preservatives, 3. that for multiple application containers, the contents should not be used for more
than one months after opening the container, 4. that for multiple application containers care should be taken to avoid
contaminations of the contents during use, 5. that the preparation is” NOT FOR INJECTION” and 6. the conditions under which the preparation should be stored.
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D15002
Quality Control Department
Drug Name : Ciprofloxacin Eye / Ear Drops 0.3%w/v IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 939
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
143
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Identification 3. pH-Limit, 3.5 to 5.5 4. Uniformity of volume. Refer-G-EAR-001. 5. Particle size (applicable to eye drops that are suspension). Refer-G-EAR-
002. 6. Sterility.Refer-G-EAR-003 7. Assay: limit-90.0-110.0% of the stated amount of Ciprofloxacin.
ADDITIONAL TESTS
Nil
LIMITS
For test 1 to 7, limit as per IP-2007.
LABELLING
The label states; 7. the names and concentrations in % or weight or volume/ml of the active
ingredients, 8. the names and concentrations of any added anti-microbial preservatives, 9. that for multiple application containers, the contents should not be used for
more than one months after opening the container, 10. that for multiple application containers care should be taken to avoid
contaminations of the contents during use, 11. that the preparation is” NOT FOR INJECTION” and 12. the conditions under which the preparation should be stored.
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers. SHELF LIFE Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D15005
Quality Control Department
Drug Name : Timolol Maleate Eye Drops IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 3, Page No. 1809
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
144
TESTS AS PER OFFICIAL MONOGRAPH
4. Description 5. Identification 6. pH-Limit, 6.5 to 7.5 7. Related substances-GC 8. Uniformity of volume. Refer-G-EAR-001. 9. Sterility.Refer-G-EAR-003 10. Assay: limit-90.0-110.0% of the stated amount of Timolol.
ADDITIONAL TESTS
Nil
LIMITS
For test 1 to 7, limit as per IP-2007.
LABELLING
The label states; 1. the strength in terms of the equivalent amount of Timolol. 2. the name and concentration of any added anti-microbial preservatives
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D15006
Quality Control Department
Drug Name : Tropicamide Eye Drops IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 3, Page No. 1837-1838
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
145
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Identification 3. pH-Limit, 4.0 to 5.8 4. Related substances 5. Uniformity of volume. Refer-G-EAR-001. 6. Sterility.Refer-G-EAR-003 7. Assay: limit-95.0-110.0% of the stated amount of Tropicamide.
ADDITIONAL TESTS
Nil
LIMITS
For test 1 to 7, limit as per IP-2007.
LABELLING
The label states; 3. the strength in terms of the equivalent amount of Tropicamide. 4. the name and concentration of any added anti-microbial preservatives
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D15011
Quality Control Department
Drug Name : Saline Nasal Drops Page 1 of 1
Synonym : Copy No. 1
Official Standards : KMSCL In-house Method
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
146
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Identification 3. Uniformity of volume- Refer-G-NAS-002 4. pH-Limit 6.0 to 7 5. Microbial limits - Total Bacterial counts - NMT 100 CFU/ML
Total yeast and mould count - NMT 100 CFU/MG Escherichia coli - should be absent. Salmonella species - should be absent. Staphylococcus aureus - should be absent. Pseudomonas aeuruginosa - should be absent.
6. Assay: Limit 90.0-110.0% of the stated amount of Sodium chloride.
ADDITIONAL TESTS
Nil
LIMITS
For test 1 to 6, limit as per KMSCL In -house method.
LABELLING
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D15008
Quality Control Department
Drug Name : Sodium Bicarbonate Ear drops BPC. Page 1 of 1
Synonym : Copy No. 1
Official Standards : British Pharmaceutical Codex 1963, Page No. 1050-1051
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
147
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Identification 3. Assay: limit-4.07to5.08%w/v of Sodium Bicarbonate.
ADDITIONAL TESTS
Nil
LIMITS
For test 1 to 3, limit as per BPC-1963.
LABELLING
Containers should be labeled “FOR EXTERNAL USE ONLY”.
QUANTITY REQUIRED FOR ANALYSIS
50 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D15009
Quality Control Department
Drug Name : Xylometazoline Nasal Drops IP Page 1 of 1
Synonym : Xylometazoline Hydrochloride Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 3, Page No. 1877-1878
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
148
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Identification 3. pH-Limit, 5.6 to 6.6 4. N(2-Aminoethyl) 4-tert-butyl-2,6-xylylacetamide 5. Assay: limit-90.0-110.0% of the stated amount of Xylometazoline Hcl.
ADDITIONAL TESTS
Nil
LIMITS
For test 1 to 5, limit as per IP-2007.
LABELLING
QUANTITY REQUIRED FOR ANALYSIS
50 Numbers.
SHELF LIFE
Minimum 2 years.
149
KKEE
RRAA
LLAA
MM
EEDD
II CCAA
LL
SSEE
RRVV
II CCEE
SS
CCOO
RRPP
OORR
AATT
II OONN
LL
TTDD
PPAARREENNTTEERRAALLSS
QQuuaalliittyy CCoonnttrrooll MMaannuuaall FFoorr
DDrruuggss AAnndd SSuupppplliieess
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D09001
Quality Control Department
Drug Name : Aciclovir Injection IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 686-687
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
150
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Appearance of the solution 4. pH- limit 10.7 to 11.7 5. Guanine 6. Related substance 7. BET- not more than 0.174 EU/MG of Acyclovir. 8. Clarity of solution-Refer-G-POW-003 9. Particulate matter- Refer- G-POW-005 10. Uniformity of weight-Refer-G-POW-002 11. Sterility- Refer-G-POW-004 12. Assay: Limit-90.0-110.0% of the stated amount of Aciclovir.
ADDITIONAL TESTS Nil.
LIMITS
For test 1 to 12, limit as per IP-2007.
LABELLING
The label states; 1. the quantity of acyclovir sodium in the sealed container in terms of the
equivalent amount of Aciclovir, 2. the strength of the constituted solution in terms of the equivalent amount of
Acyclovir in a suitable dose volume
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D05005
Quality Control Department
Drug Name : Adrenaline bitartrate Injection IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 691-692
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
151
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Appearance of the solution 4. pH- limit 2.8 to 3.6, 5. Nor adrenaline-HPLC 6. Sterility- Refer-G-INJ-005 7. Extractable volume- Refer- G-INJ-004 8. Water-not more than 2.0 % determined on 0.3grams. 9. Particulate matter- refer- G-INJ-001 10. Assay: limit-0.09% to 0.11% wt/v of Adrenaline
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 10, limit as per IP-2007.
LABELLING
The label states; 1. the quantity of active ingredients in parts per thousand (or) mg/ml in terms of
equivalent amount of adrenaline, 2. that the injection should not be used if it is pinkish (or) darker than slightly
yellow.
QUANTITY REQUIRED FOR ANALYSIS
200 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D02021
Quality Control Department
Drug Name : Amikasin Sulphate Injection IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 703-704
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
152
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Uniformity of weight-refer- G-POW-002 4. pH- limit 3.5 to 5.5. 5. BET- not more than 0.33 EU/MG of Amikacin. 6. Sterility- Refer-G-INJ-005 7. Extractable volume-Refer-G-INJ-004 8. Particulate matter- Refer- G-INJ-001(of the constituted solution) 9. Clarity of solution-Refer-G-POW-003(of the constituted solution) 10. Assay: limit - 90.0-120.0% of the stated amount of Amikacin.
ADDITIONAL TESTS
Nil
LIMITS
For test 1 to 10, limit as per IP-2007.
LABELLING
The label states the quantity of Amikacin sulphate contained in the sealed containers in terms of the equivalent amount of Amikacin.
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D03003
Quality Control Department
Drug Name : Aminophylline Injection IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 708-709
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
153
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Uniformity of weight-refer G-POW-002 4. Absorbance of the solution-at 430 nm is not more than 0.15 5. pH- limit 8.8 to 10.0,determined in 10 %wt/v solution. 6. BET- not more than 0.15 EU/MG of Ampicillin. 7. Sterility- Refer-G-INJ-005 8. Water-not more than 2.0 % determined on 0.3grams. 9. Particulate matter- Refer- G-INJ-001 10. Clarity of solution-Refer-G-POW-003 11. Assay: contains Theophylline equivalent to not less than 73.25% and not
more than 88.25% of the stated amount of Aminophylline and not more than 0.295 gm of the ethylene diamine for each gram of anhydrous Theophylline determined in the assay for Theophylline.
ADDITIONAL TESTS Nil
LIMITS For test 1 to 11, limit as per IP-2007.
LABELLING
The label states the (1) strength in terms of the equivalent amount of anhydrous Aminophylline in suitable dose volume; (2) the route of injection; (3) that the injections not to be used if crystals have separated.
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D21012
Quality Control Department
Drug Name : Anti Snake Venom (Freeze Dried) Polyvalent 10ml Vial Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
154
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Identification Tests 3. Sterility 4. Assay
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 4, limit as per IP.
LABELLING
The label states; 1. The number of mouse units per container 2. The volume of water for injection to be used for reconstitution
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D02008
Quality Control Department
Drug Name : Ampicillin Injection IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 731-732
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
155
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Uniformity of weight- Refer G-POW-002 4. Absorbance of the solution- at 430nm is not more than 0.15 5. pH - Limit 8.0 to 10.0, determined in10 minutes after dissolving in 10%w/v
solution. 6. Specific optical rotation- +258° to +287° determined in a 0.25%w/v solution of
potassium hydrogen phthalate. 7. N,N-dimethyl aniline- Not more than 20 ppm 8. Dichloromethane- Not more than 0.2%w/v 9. Heavy metals 10. BET- Not more than 0.15 EU/MG of Ampicillin. 11. Sterility- Refer-G-INJ-005 12. Water-not more than 2.0 % determined on 0.3grams. 13. Particulate matter- Refer- G-INJ-001(of the constituted solution) 14. Clarity of solution- Refer-G-POW-003(of the constituted solution) 15. Assay: limit - 95.0-105.0% of the stated amount of Ampicillin
ADDITIONAL TESTS Nil LIMITS For test 1 to 15, limit as per IP-2007.
LABELLING
The label states the quantity of Ampicillin sodium contains in the sealed containers in terms of the equivalent amount of anhydrous Ampicillin.
QUANTITY REQUIRED FOR ANALYSIS 100 Numbers.
SHELF LIFE Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D06001& D04007 Quality Control Department
Drug Name : Atropine Sulphate Injection IP Page 1 of 1
Synonym : Atropine Injection Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 754-755
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
156
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. pH- limit 3.0 to 5.5 4. Sterility- Refer-G-INJ-005 5. Particulate matter- Refer- G-INJ-001 6. Particulate Contamination- Refer- G-INJ-002 7. Extractable Volume- Refer- G-INJ-004 8. Assay: Limit-90.0-110.0% of the stated amount of Atropine Sulphate.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 8, limit as per IP-2007.
LABELLING
Nil.
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D02009
Quality Control Department
Drug Name : Benzyl Penicillin Injection IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 793-794
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
157
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Uniformity of weight - Refer- G-POW-002 4. Absorbance of the solution - at 430nm is not more than 0.15 5. pH - Limit 5.5 to 7.5, determined in 10%w/v solution. 6. Related substance-HPLC 7. BET- Not more than 0.16 EU/MG. 8. Sterility- Refer-G-INJ-005 9. Loss on drying- Not more than 1.0% determined on 1.0 gram at 105°C 10. Particulate matter- Refer- G-INJ-001(of the constituted solution) 11. Clarity of solution-Refer-G-POW-003(of the constituted solution) 12. Assay: limit-95.0-105.0% of the stated amount of Benzyl Penicillin.
ADDITIONAL TESTS
Nil
LIMITS
For test 1 to 12, limit as per IP-2007.
LABELLING
The label states (1) whether the content are Benzyl Penicillin Potassium or Benzyl Penicillin Sodium; (2) the name of any added buffering agents.
QUANTITY REQUIRED FOR ANALYSIS
200 Numbers.
SHELF LIFE Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D05004
Quality Control Department
Drug Name : Betamethasone Sodium Injection IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 801-802
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
158
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. pH- limit 2.8 to 3.6, 4. Sterility- Refer-G-INJ-005 5. Extractable volume- Refer- G-INJ-004 6. Particulate matter- Refer- G-INJ-001 7. Assay: limit-92.5% to 107.5% of the stated amount of Betamethasone.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 7, limit as per IP-2007.
LABELLING
The label states the strength in terms of the equivalent amount of Betamethasone in a suitable dose-volume.
QUANTITY REQUIRED FOR ANALYSIS
200 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D24009
Quality Control Department
Drug Name : Bleomycin Injection IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 810-812
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
159
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. pH- limit 4.5 to 6.0 determined in a solution containing 10 units/ml. 4. Copper-NMT0.02% 5. Content of Bleomycins 6. BET-NMT 10.0EU/unit of Bleomycin. 7. Loss on drying - NMT 6.0% determined by drying the combined contents of
2 containers in an oven at 60°C at a pressure not exceeding 0.7kPa for 3 hrs.
8. Uniformity of weight- Refer-G-POW-002 9. Clarity of the constituted solution Refer-G-POW-003 10. Particulate matter- Refer- G-INJ-001 11. Sterility- Refer-G-INJ-005 12. Assay: limit-90.0-120.0% of the stated amount of Bleomycin. And the
content of Bleomycins is:- Bleomycin A2, between 55.0% and 70.0%; Bleomycin B2, between 25.0 % and 32.0%; sum of Bleomycin A2 and Bleomycin B2, 85.0%; Di-methyl Bleomycin A2, NMT 5.5%; other related substances NMT 9.5%.
ADDITIONAL TESTS Nil. LIMITS For test 1 to 12, limit as per IP-2007. LABELLING The label states the total number of units contained in a sealed container. QUANTITY REQUIRED FOR ANALYSIS 200 Numbers. SHELF LIFE Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D04017
Quality Control Department
Drug Name : Bupivacaine Hydrochloride in Dextrose Injection USP Page 1 of 1
Synonym : Copy No. 1
Official Standards : US Pharmacopeia 2008, Volume 2, Page No. 1570
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
160
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. BET- Not more than 1.8 USP EU/MG of Bupivacaine Hydrochloride 4. pH- Limit 4.0 to 6.5. 5. Volume in container 6. Particulate matter 7. Sterility 8. Assay: limit - 93.0 to 107.0 % of the labelled amount of Bupivacaine
Hydrochloride and Dextrose
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 8, limit as per USP-2008.
LABELLING
Nil.
QUANTITY REQUIRED FOR ANALYSIS
200 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D22003
Quality Control Department
Drug Name : Calcium Gluconate Injection IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 841
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
161
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Appearance of solution 4. pH-Limit 6.0 to 8.2 5. BET-NMT 0.17 EU/mg of Calcium Gluconate. 6. Extractable volume- Refer- G-INJ-004 7. Particulate matter-Refer-G-INJ-001 8. Sterility- Refer- G-INJ-005. 9. Assay: limit-contains a quantity of calcium equivalent to NLT 8.5% and NMT
9.4% of the stated amount of Calcium Gluconate.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 9, limit as per IP-2007.
LABELLING
The label states; 1. the strength as a percentage w/v of Calcium Gluconate equivalent to the total
amount of Calcium present, 2. that solutions containing visible solid particles must not be used, 3. the percentage of any added stabilizing agent.
QUANTITY REQUIRED FOR ANALYSIS
200 Numbers.
SHELF LIFE
Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D06008
Quality Control Department
Drug Name : Carboprost Injection IP Page 1 of 1
Synonym : Carboprost Tromethamine Injection Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 860
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
162
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. pH-Limit 7.0 to 8.0 4. BET- NMT 714.3 EU/MG of Carboprost Tromethamine. 5. Refractive index-Limit-1.481 to 1.486 determined at 20°C 6. Particulate matter-Refer-G-INJ-001 7. Sterility- Refer- G-INJ-005. 8. Extractable volume- Refer- G-INJ-004. 9. Assay: limit - 90.0-110.0% of the stated amount of Carboprast
Tromethamine. ADDITIONAL TESTS Nil. LIMITS
For test 1 to 9, limit as per IP-2007.
LABELLING
The label states the strength in terms of the equivalent amount of Carboprost in a suitable dose – volume.
QUANTITY REQUIRED FOR ANALYSIS
200 Numbers.
SHELF LIFE Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D02026
Quality Control Department
Drug Name : Cefotaxime Injection IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 875
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
163
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. pH- Limit 4.5 to 6.5,determined in a 10.0%w/v solution. 4. BET- Not more than 0.2 EU/MG of Cefotaxime 5. Sterility- Refer-G-INJ-005 6. Water- Not more than 6.0% determined on 0.15grams. 7. Particulate Matter- Refer- G-INJ-001(of the constituted solution) 8. Clarity of solution- Refer-G-POW-003(of the constituted solution) 9. Assay: Limit - 90.0-115.0% of the stated amount of Cefotaxime.
ADDITIONAL TESTS
Nil
LIMITS
For test 1 to 9, limit as per IP-2007.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D02010
Quality Control Department
Drug Name : Cefotaxime Sodium Injection IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 875
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
164
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Uniformity of weight- Refer G-POW-002 4. pH - limit 4.5 to 6.5,determined in 10 %wt/v solution. 5. BET- Not more than 0.20 EU/MG. 6. Sterility- Refer-G-INJ-005 7. Water- Not more than 6.0% determined on 0.15 gram. 8. Particulate matter- Refer- G-INJ-001 (of the constituted solution) 9. Clarity of solution- Refer-G-POW-003 (of the constituted solution) 10. Assay: limit - 90.0-115.0% of the stated amount of Cefotaxime.
ADDITIONAL TESTS
Nil
LIMITS
For test 1 to 10, limit as per IP-2007.
LABELLING
QUANTITY REQUIRED FOR ANALYSIS
200 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D02019 & D02020 Quality Control Department
Drug Name : Cefuroxime Injection IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 883-884
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
165
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Uniformity of weight - Refer- G-POW-002 4. pH - limit 6.0 to 8.5,determined in a 10 %wt/v solution. 5. BET - not more than 0.10 EU/MG of Cefuroxime. 6. Sterility - Refer-G-INJ-005 7. Water - not more than 3.5 % determined on 0.15grams. 8. Particulate matter - Refer- G-INJ-001(of the constituted solution) 9. Clarity of solution - Refer-G-POW-003(of the constituted solution) 10. Assay:- Limit - 90.0-120.0% of the stated amount of Cefuroxime.
ADDITIONAL TESTS Nil LIMITS
For test 1 to 10, limit as per IP-2007.
LABELLING
The label states the quantity of Ampicillin sodium contains in the sealed containers in terms of the equivalent amount of anhydrous Ampicillin.
QUANTITY REQUIRED FOR ANALYSIS 100 Numbers.
SHELF LIFE Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D05008
Quality Control Department
Drug Name : Chlorpheniramine Maleate Injection IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 920
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
166
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. pH- limit 4.0 to 5.2, 4. Related substances 5. Sterility- Refer-G-INJ-005 6. Extractable volume-Refer- G-INJ-004 7. Particulate matter- Refer- G-INJ-001 8. Clarity of solution-Refer-G-POW-003 9. Assay: limit-90.0-110.0% of the stated amount of Chlorpheniramine Maleate.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 9, limit as per IP-2007.
STORAGE
Store protected from light.
LABELLING
Nil.
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D02012
Quality Control Department
Drug Name : Ciprofloxacin Injection IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 936-938
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
167
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. pH- limit 3.5 to 4.6. 4. Ciprofloxacin ethylene diamine analog - Not more than 0.5% determined by
the method described in the assay. 5. Lactic acid- Limit 0.288 mg to 0.352 mg for each mg of ciprofloxacin stated
on the label. 6. Dextrose (if present) - 4.75 to 5.25%wt/v 7. Sodium Chloride (If Present) - 0.855 To 0.945 % 8. BET- Not more than 0.25 EU/MG of Ciprofloxacin. 9. Sterility- Refer-G-INJ-005 10. Particulate matter- Refer- G-INJ-001 11. Clarity and colour of solution- Refer-G-POW-003 12. Extractable volume- Refer-INJ-004 13. Assay: limit - 90.0-110.0% of the stated amount of Ciprofloxacin
ADDITIONAL TESTS Nil LIMITS For test 1 to 13, limit as per IP-2007.
LABELLING
The label states whether dextrose or sodium chloride has been used for preparing the injection.
QUANTITY REQUIRED FOR ANALYSIS 200 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D02012
Quality Control Department
Drug Name : Ciprofloxacin Injection IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 936-938
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
167
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. pH- limit 3.5 to 4.6. 4. Ciprofloxacin ethylene diamine analog - Not more than 0.5% determined by
the method described in the assay. 5. Lactic acid- Limit 0.288 mg to 0.352 mg for each mg of ciprofloxacin stated
on the label. 6. Dextrose (if present) - 4.75 to 5.25%wt/v 7. Sodium Chloride (If Present) - 0.855 To 0.945 % 8. BET- Not more than 0.25 EU/MG of Ciprofloxacin. 9. Sterility- Refer-G-INJ-005 10. Particulate matter- Refer- G-INJ-001 11. Clarity and colour of solution- Refer-G-POW-003 12. Extractable volume- Refer-INJ-004 13. Assay: limit - 90.0-110.0% of the stated amount of Ciprofloxacin
ADDITIONAL TESTS Nil LIMITS For test 1 to 13, limit as per IP-2007.
LABELLING
The label states whether dextrose or sodium chloride has been used for preparing the injection.
QUANTITY REQUIRED FOR ANALYSIS 200 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D24012 & D24013 Quality Control Department
Drug Name : Cisplastin Injection IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 941-942
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
168
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. pH-Limit 3.5o 6.5,determined in a solution constituted as directed in the
label,in water for injections 4. Related substances 5. BET-Limit NMT 2.0EU/mg of Cisplastin 6. Uniformity of weight- Refer-G-POW-002 7. Clarity of the constituted solution Refer-G-POW-003 8. Particulate matter-Refer-G-INJ-001 9. Sterility- Refer- G-INJ-005. 10. Assay: limit-90.0-110.0% of the stated amount of Cisplastin.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 10, limit as per IP-2007.
LABELLING
Nil.
QUANTITY REQUIRED FOR ANALYSIS
200 Numbers.
SHELF LIFE
Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D02029
Quality Control Department
Drug Name : Cloxacillin Injection IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 961
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
169
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. pH- limit 5.0 to 7.0. 4. BET- not more than 0.40 EU/MG of Cloxacillin. 5. Clarity of solution-Refer-G-POW-001 6. Water-NMT 4.5% 7. Particulate matter- Refer- G-INJ-001 8. Sterility- Refer-G-INJ-005 9. Assay: Limit-90.0-110.0% of the stated amount of Cloxacillin.
ADDITIONAL TESTS
Nil
LIMITS
For test 1 to 9, limit as per IP-2007.
STORAGE
Store protected from moisture at a temperature not exceeding 30°C
LABELLING
The label states the quantity of Cloxacillin Sodium contained in the sealed container in terms of the equivalent amount of Cloxacillin.
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D24003 & D24004 Quality Control Department
Drug Name : Cyclophosphamide Injection IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 979-980
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
170
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. pH-Limit 4.0 to 6.0,determined in a 2.0% w/v solution immediately after
preparation 4. Related substances 5. BET-Limit NMT 0.2EU/mg of Cyclophosphamide. 6. Uniformity of weight- Refer-G-POW-002 7. Clarity of the constituted solution Refer-G-POW-003 8. Particulate matter-Refer-G-INJ-001 9. Sterility- Refer- G-INJ-005. 10. Assay: limit-92.5-107.5% of the stated amount of Cyclophosphamide
ADDITIONAL TESTS Nil. LIMITS For test 1 to 10, limit as per IP-2007.
LABELLING
The label states; 1. the quantity of cyclophosphamide in terms of the equivalent amount of
anhydrous Cyclophosphamide, 2. the volume of water for injection to be added, 3. that the solution should be used immediately after preparation.
QUANTITY REQUIRED FOR ANALYSIS 100 Numbers.
SHELF LIFE Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D12001
Quality Control Department
Drug Name : Cyanocobalamin Injection IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 976-977
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
171
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. pH- limit 3.8 to 5.5 4. Related substance. 5. Particulate matter- Refer- G-INJ-001 6. Extractable volume-Refer-G-INJ-004 7. Sterility- Refer-G-INJ-005 8. Assay: Limit-95.0-105.0% of the stated amount of Cyanocobalamin.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 8, limit as per IP-2007.
LABELLING
The label states the strength in terms of the equivalent amount of anhydrous Cyanocobalamin in a suitable volume.
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D24021
Quality Control Department
Drug Name : Cytosine Arabinoside Injection IP Page 1 of 1
Synonym : Cytarabine, B-Ctosine Arabinoside Injection Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 957
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
172
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. pH-Limit 4.0 to 6.0 4. Related substances 5. Water 6. BET-NMT 0.07EU/MG 7. Clarity of solution-Refer-G-POW-003 8. Particulate matter-Refer-G-INJ-001 9. Uniformity of weight-Refer-G-pow-002 10. Sterility- Refer- G-INJ-005. 11. Assay: limit- 95.0-105.0% of the stated amount of Cytarabine.
ADDITIONAL TESTS Nil.
LIMITS
For test 1 to 11, limit as per IP-2007.
LABELLING
The constituted solution should be used immediately after preparation but, in any case, within the period recommended by the manufacturer.
QUANTITY REQUIRED FOR ANALYSIS
200 Numbers.
SHELF LIFE
Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D06006
Quality Control Department
Drug Name : Desferrioxamine Injection BP Page 1 of 1
Synonym : Desferrioxamine Mesilate Copy No. 1
Official Standards : British Pharmacopoeia 2009, Volume 3, Page No. 2486
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
173
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Related substances-HPLC 4. Uniformity of weight 5. Sterility 6. Particulate Contamination-sub visible particles 7. Assay: limit-94.0-110.0% of the stated amount of Desferrioxamine Mesilate.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to7, limit as per BP-2009.
LABELLING
Amount of active ingredients contained in the sealed container. Direction for the preparation of the injection.
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D05001
Quality Control Department
Drug Name : Dexamethasone Sodium Injection IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 1007-1008
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
174
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. pH- limit 7.0 to 8.5, 4. Free Dexamethasone 5. Sterility- Refer-G-INJ-005 6. Extractable volume. Refer- G-INJ-004 7. Particulate matter- Refer- G-INJ-001 8. Clarity of solution-Refer-G-POW-003 9. Assay: limit - 95.0-105.0% of the stated amount of Dexamethasone
Phosphate.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 8, limit as per IP-2007.
LABELLING
The label states the strength in terms of the equivalent amount of Dexamethasone Phosphate in a suitable dose volume.
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D12007
Quality Control Department
Drug Name : Dextran 40 with Sodium Chloride 0.9% IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 1008-1010
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
175
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. pH- limit 4.0 to 7.0 4. Molecular size 5. Acetone 6. Ethanol 7. Heavy metals 8. Nitrogen 9. Sulphated ash 10. Foreign proteins 11. BET-NMT1.25EU/ML 12. Particulate contamination- Refer- G-INF-001 13. Sterility- Refer-G-INF-002 14. Assay: Limit-contains NLT 9.0 % and NMT 11.0 %w/v of Dextran.
ADDITIONAL TESTS Nil.
LIMITS For test 1 to 14, limit as per IP-2007.
LABELLING
The label states; (1) the strength as the percentage w/v of Dextran, (2) the name of the solvent, (3) the strength of leuconostoc mesenteroids used, (4) that the infusion should not be used if it is cloudy or if a deposit is present.
QUANTITY REQUIRED FOR ANALYSIS 100 Numbers.
SHELF LIFE Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code :
D18003, D18004, D18005 & D18006 Quality Control Department
Drug Name : Dextrose Injection IP Page 1 of 1
Synonym : Dextrose I.V Infusion, Glucose I.V Infusion Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 1016
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
176
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. pH-Limit 3.5 to 6.5 4. 5-Hydroxy methyl furfural and Related substances 5. Heavy metals-Limit 0.3ppm 6. Particulate Contamination-Refer-G-INF-002 7. BET-NMT 0.5EU/ML. 8. Sterility- Refer- G-INF-002. 9. Assay: 95.0 to 105.0 % of the stated amount of anhydrous Dextrose.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 9, limit as per IP-2007.
LABELLING
The label states; 1. The strength as a percentage w/v of anhydrous Dextrose. 2. That the injection should not be used if it contains visible solid particles.
QUANTITY REQUIRED FOR ANALYSIS
50 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D07007
Quality Control Department
Drug Name : Diazepam Injection IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 1018
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
177
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. pH : 6.2 to 6.9 4. BET : not more than 11.6 EU /MG of Diazepam 5. Sterility - Refer- G-INJ-005 6. Particulate matter - Refer- G-INJ-001 7. Extractable volume -Refer-G-INJ-004 8. Clarity of solution - Refer-G-POW-003 9. Assay: limit - 90.0-110.0% of the stated amount of Diazepam
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 9, limit as per IP-2007.
LABELLING
Nil.
QUANTITY REQUIRED FOR ANALYSIS
200 Numbers.
SHELF LIFE
Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D01005
Quality Control Department
Drug Name : Diclofenac Sodium Injection IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 1021
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
178
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. pH – limit 8.1 to 9.0 4. Sterility- Refer-G-INJ-005 5. Particulate matter- Refer- G-INJ-001 6. Extractable volume- Refer-G-INJ-004 7. Clarity of solution- Refer-G-pow-003 8. Assay: limit- 95.0-105.0% of the stated amount of Diclofenac sodium.
ADDITIONAL TESTS
Nil
LIMITS
For test 1 to 8, limit as per IP-2007.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D20009
Quality Control Department
Drug Name : Dicyclomine Hydrochloride Injection IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 1023
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
179
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. BET-NMT 17.2EU/mg of Dicyclomine Hydrochloride. 4. Particulate matter- Refer- G-INJ-001 5. Extractable volume- Refer- G-INJ-004 6. Sterility- Refer-G-INJ-005 7. Assay: limit-93.0-107.0% of the stated amount of Dicyclomine Hydrochloride.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 7, limit as per IP-2007.
LABELLING
Nil.
QUANTITY REQUIRED FOR ANALYSIS
200 Numbers.
SHELF LIFE
Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D13015
Quality Control Department
Drug Name : Digoxin Injection IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 1036-1037
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
180
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. pH- limit 6.7 to 7.3. 4. Sterility- Refer-G-INJ-005 5. Particulate matter- Refer- G-INJ-001 6. Extractable volume-Refer-INJ-004 7. Assay: limit-90.0-110.0% of the stated amount of Digoxin.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 7, limit as per IP-2007.
LABELLING
Nil.
QUANTITY REQUIRED FOR ANALYSIS
200 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D06009
Quality Control Department
Drug Name : Dimercaprol Injection IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 1043-1044
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
181
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Acidity 4. Refractive index-Limit-1.481 to 1.486 determined at 20°C 5. Weight per ml-Limit-about 0.95 grams 6. Particulate matter- 7. Sterility- Refer- G-INJ-005. 8. Extractable volume- Refer- G-INJ-004. 9. Assay: limit-90.0-110.0% of the stated amount of Dimercaprol.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 9, limit as per IP-2007.
LABELLING
The label states that (1) the nature of the solvent; (2) the injection is meant for IM use only.
QUANTITY REQUIRED FOR ANALYSIS
200 Numbers.
SHELF LIFE
Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D13017
Quality Control Department
Drug Name : Dobutamine Hydrochloride Injection USP Page 1 of 1
Synonym : Copy No. 1
Official Standards : US Pharmacopeia 2008, Volume 2, Page No. 2002-2003
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
182
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. BET- NMT 2.08 USP EU/MG of Dobutamine 4. pH- limit 2.5 to 5.5,Refer USP page no-314 5. Particulate matter- ReferUSP-2008,page no-311 6. Sterility 7. Volume in container-Refer USP, page no-36 & 619. 8. Assay: limit-90.0-115.0% of the labelled amount of Dobutamine HCl
equivalent to Dobutamine.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 8, limit as per USP-2008
LABELLING
Label it to indicate that the injection is to be diluted to appropriate strength with a suitable parenteral vehicle prior to administration.
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D13016
Quality Control Department
Drug Name : Dopamine Hydrochloride Injection USP Page 1 of 1
Synonym : Copy No. 1
Official Standards : US Pharmacopeia 2008, Volume 2, Page No. 2013
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
183
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. BET- NMT 16.67 USP EU/MG of Dopamine Hydrochloride. Refer page no-
98 4. pH- limit 2.5 to 5.0,Refer USP page no-314 5. Particulate matter- ReferUSP-2008,page no-311 6. Sterility 7. Volume in container-Refer USP, page no-36 & 619. 8. Assay: limit-90.0-115.0% of the labelled amount of Dopamine HCl.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 8, limit as per USP-2008.
LABELLING
1. Label list to indicate that the injection is to be diluted with suitable parenteral vehicle prior to Intravenous Infusion
2. It may contain antioxidant and as per USP specification for labelling. Refer page no-34 of USP
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D24024
Quality Control Department
Drug Name : Doxurubicin Hydrochloride Injection IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 1060-1061
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
184
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. pH- Limit, 2.5 to 4.5 for the preformed solution; 4.5 to 6.5 determined in the
injection prepared in accordance with the direction in the label. 4. BET-NMT2.2 EU/MG of Doxorubicin Hydrochloride. 5. Particulate matter- 6. Clarity and Color of constituted solution. 7. Sterility- Refer- G-INJ-005. 8. Extractable volume- Refer- G-INJ-004. 9. Assay: limit-90.0-115.0% of the stated amount of Doxorubicin Hydrochloride.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 9, limit as per IP-2007.
LABELLING
Nil.
QUANTITY REQUIRED FOR ANALYSIS
200 Numbers.
SHELF LIFE
Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D18008
Quality Control Department
Drug Name : Electrolyte M Injection (Maintenance) Page 1 of 1
Synonym : Copy No. 1
Official Standards : KMSCL In-house Method and Indian Pharmacopoeia
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
185
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. pH-Limit 3.0 to 7.0 4. 5-Hydroxy methyl furfural and Related substances(Refer IP-2007) 5. Particulate Contamination-Refer-G-INF-002 6. Sterility- Refer- G-INF-002. 7. Assay: 95.0 to 120.0 % of the total chloride and 90.0 to 110.0% of Dextrose
(anhydrous), Acetate and total Sodium and Potassium.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 7, limit as per IP-2007.
LABELLING
Nil.
QUANTITY REQUIRED FOR ANALYSIS
50 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D18007
Quality Control Department
Drug Name : Electrolyte P Injection (Paediatric) Page 1 of 1
Synonym : Copy No. 1
Official Standards : KMSCL In-house Method and Indian Pharmacopoeia
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
186
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. pH-Limit 5.0 to 6.0 4. Particulate Contamination-Refer-G-INF-002 5. Sterility- Refer- G-INF-002. 6. Assay: 90.0 % to 110.0% of total Sodium, Potassium, Chloride, Magnesium
phosphate and dextrose (anhydrous).
ADDITIONAL TESTS
Nil.
LIMITS
For tests 1 to 6, Limits as per KMSCL In house method and IP.
LABELLING
Nil.
QUANTITY REQUIRED FOR ANALYSIS
50 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D24014
Quality Control Department
Drug Name : Etoposide Injection IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 1117
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
187
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. pH- limit -2.7 to 3.5 determined in a solution containing the equivalent of 5.0
pH-Limit 3.0 to 4.0,determined in a solution prepared by diluting a volume of the concentrate containing 0.1 gram of Etoposide to 50.0 ml with carbondioxide free water.
4. Cis-Etoposide 5. Uniformity of weight 6. Clarity of the constituted solution 7. Particulate matter-Refer-G-INJ-001 8. Sterility- Refer- G-INJ-005. 9. Assay: limit-95.0-105.0% of the stated amount of Etoposide.
ADDITIONAL TESTS Nil.
LIMITS For test 1 to 9, limit as per IP-2007.
LABELLING
The label states; 1. the direction for dilution of the contents, 2. that the diluted injection is to be given by Intravenous injection, 3. that the concentrate should be protected from light.
QUANTITY REQUIRED FOR ANALYSIS
200 Numbers.
SHELF LIFE
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D24028
Quality Control Department
Drug Name : Fluorouracil Injection IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 1134
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
188
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. pH-Limit 8.5 to 9.5 4. Related substances 5. Urea 6. Particulate matter-Refer-G-INJ-001 7. Sterility- Refer- G-INJ-005. 8. Extractable volume- Refer- G-INJ-004. 9. Assay: limit-90.0-110.0% of the stated amount of Fluorouracil.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 9, limit as per IP-2007.
LABELLING
The label states; 1. the strength in terms of the equivalent amount of Fluoro uracil in a suitable
dose – volume. 2. that if separation has occurred, the injection should be heated to 60°C,
shaken vigorously and allowed to cool to body temperature prior to use.
QUANTITY REQUIRED FOR ANALYSIS
200 Numbers.
SHELF LIFE
Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D17013
Quality Control Department
Drug Name : Fluphenazine Decanoate Injection IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 1135-1136
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
189
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Related substance 4. Extractable volume. G-INJ-004 5. Sterility- refer-G-INJ-005 6. Particulate matter- Refer- G-INJ-001 7. Assay: limit-90.0-110.0% of the stated amount of Fluphenazine Decanoate.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 7, limit as per IP-2007.
LABELLING
The label states that the injection is for IM injection only.
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D19002
Quality Control Department
Drug Name : Frusemide Injection IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 1150-1151
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
190
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. pH - Limit 8.0 to 9.3 4. Free amines 5. BET – NMT 3.5EU/mg of Frusemide. 6. Particulate matter - Refer-G-INJ-001 7. Sterility- Refer- G-INJ-005. 8. Extractable volume - Refer- G-INJ-004. 9. Assay: limit - 95.0-105.0% of the stated amount of Frusemide.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 9, limit as per IP-2007.
LABELLING
Nil.
QUANTITY REQUIRED FOR ANALYSIS
200 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D21020
Quality Control Department
Drug Name : Gamma Globulin (I.V) IP Page 45 of 1
Synonym : Human Normal Immunoglobulin, Normal Immunoglobulin, Immune Human Serum Globulin, Human Gamma Globulin.
Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 3, Page No. 2094
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
191
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. pH-Limit 6.4 to 7.2 4. Protein composition 5. Molecular size 6. Stability 7. Particulate matter/Particulate contamination-Refer-G-INJ-001 & Refer-G-INJ-002 8. Sterility- Refer- G-INJ-005. 9. Extractable volume/Uniformity of weight- Refer- G-INJ-004. 10. Assay: limit-90.0-110.0% of the quantity of protein stated on the label and in any
case, NLT10.0%w/v and NMT18.0 w/v of protein. Freeze-dried Human Normal immunoglobulin complies with the following additional requirements; 11. Solubility rate. 12. Loss on drying - NMT 2.0% Human Normal Immunoglobulin intended for use in the prevention of infective hepatitis (hepatitis A) complies with the following additional requirement; 13. Anti-hepatitis A activity - Limit: - The stated potency is NLT 100 units/ml. The
estimated potency is NLT the stated potency. The fiducial limits of error are NLT 80.0% and NMT125.0%
LIMITS- For test 1 to 13, limit as per IP-2007. LABELLING
The label states; 1. the volume and the protein concentration expressed in G/L or for freeze-dried
preparations, the total amount of protein in the container. 2. the type of source material 3. the name and quantity of any added preservative or stabilizing agent 4. the recommended human dose 5. that it is meant for IM injection only 6. the storage conditions.
QUANTITY REQUIRED FOR ANALYSIS-200 Numbers. SHELF LIFE- Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D02013
Quality Control Department
Drug Name : Gentamycin Injection IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 1164-1165
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
192
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. pH- Limit 3.0 to 5.0 4. Composition of Gentamycin sulphate - HPLC. 5. BET- Not more than 1.67 EU/MG of Gentamycin. 6. Sterility- Refer-G-INJ-005 7. Particulate matter- Refer- G-INJ-001 8. Extractable volume- Refer-INJ-004 9. Assay: Limit - 95.0-110.0% of the stated amount of Gentamycin.
ADDITIONAL TESTS
Nil
LIMITS
For test 1 to 9, limit as per IP-2007.
LABELLING
The label states the strength in terms of the equivalent amount of Gentamycin in a suitable dose.
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D04019
Quality Control Department
Drug Name : Glycopyrrolate USP Page 1 of 1
Synonym : Copy No. 1
Official Standards : US Pharmacopeia 2008, Volume 2, Page No. 2289
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
193
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. BET- Not more than 555.5 USP EU/MG of Glycopyrrolate. 4. pH- Limit 2.0 to 3.0. 5. Volume in container 6. Particulate matter-Refer page no-36 Vol-1 of USP 7. Sterility 8. Assay: limit- 93.0 to 107.0% of the labelled amount of Glycopyrrolate.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 8, limit as per USP-2008.
LABELLING
Refer page no-34 of USP, Volume-I.
QUANTITY REQUIRED FOR ANALYSIS
200 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D17012
Quality Control Department
Drug Name : Haloperidol Injection IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 181-1182
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
194
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. pH-Limit 2.8 to 3.6 4. Related substances 5. Extractable volume. Refer- G-INJ-004 6. Sterility- Refer-G-INJ-005 7. Particulate matter- Refer- G-INJ-001 8. Assay: limit-90.0-110.0% of the stated amount of Haloperidol.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 8, limit as per IP-2007.
LABELLING
The label states that the injection is for IM injection only.
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D12003
Quality Control Department
Drug Name : Heparin Sodium Injection IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 1185-1186
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
195
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. pH- limit 5.5 to 8.0 4. BET-NMT0.03 Endotoxin per unit of Heparin 5. Particulate matter- Refer- G-INJ-001 6. Extractable volume-Refer-G-INJ-004 7. Sterility- Refer-G-INJ-005 8. Assay: Limit-90.0-110.0% of the stated potency in terms of units/ml.
ADDITIONAL TESTS Nil.
LIMITS
For test 1 to 8, limit as per IP-2007.
LABELLING
The label states; 1. the strength in terms of the number of units in a suitable dose volume except
that for multiple dose containers the strength is stated as the number of Units/ml.
2. the source of the material (lung or mucosal), 3. when no anti-microbial preservative is present that the injection contain no
anti microbial preservative, 4. that any portion of the contents not used at once should be discarded
QUANTITY REQUIRED FOR ANALYSIS 100 Numbers.
SHELF LIFE Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D21011
Quality Control Department
Drug Name : Human Anti-D Immunoglobulin IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 3, Page No. 2078
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
196
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. B19 Virus DNA maximum 104 IU/ML (if required), 3. Potency
Limit: The estimated potency is NLT 90.0%of the stated potency. The confidence limit (P=0.95) are NLT 80.0% and NMT 120.0% of the estimated potency.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 3, limit as per IP-2007.
LABELLING
Ref as per IP, Vol-3 page no-2079
QUANTITY REQUIRED FOR ANALYSIS
200 Numbers.
SHELF LIFE
Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D05002
Quality Control Department
Drug Name : Hydrocortisone Sodium Succinate Injection IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 1267
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
197
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. pH- limit -6.5 to 8.0 determined in a solution containing the equivalent of 5.0
% wt/v of hydrocortisone 4. Related substance-HPLC 5. Uniformity of weight-Refer-G-POW-002 6. Sterility- Refer-G-INJ-005 7. Extractable volume.Refer- G-INJ-004 8. Particulate matter- (of constituted solution)Refer- G-INJ-001 9. Clarity of solution-(of constituted solution)Refer-G-POW-003 10. Assay: limit-95.0-105.0% of the stated amount of Hydrocortisone
ADDITIONAL TESTS Nil. LIMITS
For test 1 to 10, limit as per IP-2007.
LABELLING
The label states; 1. the strength in terms of the equivalent amount of hydrocortisone, 2. that the prepared solution should be used only if it is clear, 3. that the solution should be used immediately after preparation.
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D12006
Quality Control Department
Drug Name : Hydroxy Ethyl Starch I.V Infusion Page 1 of 1
Synonym : Copy No. 1
Official Standards : KMSCL In-house Method
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
198
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. pH- limit 5.0 to 6.0 4. Particulate Contamination 5. Sterility- Refer-G-INJ-005 6. Assay: Limit-90.0-110.0% of the Hydroxyethyl starch and sodium chloride.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 6, limit as per KMSCL In-house method.
LABELLING
Nil.
QUANTITY REQUIRED FOR ANALYSIS
50 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D23001
Quality Control Department
Drug Name : Iohexol Injection USP Page 1 of 1
Synonym : Copy No. 1
Official Standards : US Pharmacopeia 2008, Volume 2, Page No. 2430
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
199
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. BET- NMT 0.2 USP EU/ 50MG of Iodine 4. pH- limit 6.8 to 7.7 5. Particulate matter 6. Free iodide 7. Sterility 8. Volume in container 9. Assay for Iodine: limit-95.0-105.0% of the labelled amount of Iohexol as
organically bound Iodine.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 9, limit as per USP-2008.
LABELLING
1. Label containers of injection to direct the user to discard any unused portion. 2. The labelling states also that it is not to be used if it is discoloured or
contains a precipitate. Label also states its route of administration.
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D04001
Quality Control Department
Drug Name : Ketamine Injection IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 1267
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
200
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. pH- limit 3.0 to 5.5,determined in10 minutes after dissolution in 10 %wt/v
solution. 4. BET- not more than 0.40 EU/MG of Ketamine HCl 5. Sterility- Refer-G-INJ-005 6. Particulate matter- Refer- G-INJ-001 7. Extractable volume- Refer- G-INJ-004 8. Assay: limit-95.0-105.0% of the stated amount of Ketamine.
ADDITIONAL TESTS
Nil
LIMITS
For test 1 to 8, limit as per IP-2007.
LABELLING
The label states the strength in terms of Ketamine in a suitable dose volume.
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D24015
Quality Control Department
Drug Name : Leucovorin Calcium Injection USP Page 1 of 1
Synonym : Copy No. 1
Official Standards : US Pharmacopeia 2008, Volume 2, Page No. 2509-2510
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
201
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. BET- NMT 1.95 USP EU/MG of Leucovorin calcium. 4. pH- limit 6.5 to 8.5. 5. Sterility 6. Foreign & Particulate matter 7. Volume in container-Refer USP, page no-36 & 619. 8. Assay: limit - 90.0-120.0% of the labelled amount of Leucovorin.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 8, limit as per USP-2008.
LABELLING
Nil.
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D04018
Quality Control Department
Drug Name : Lignocaine 2% with Adrenaline Injection IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 1300
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
202
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. pH – limit 3.0 to 4.5 4. Sterility- Refer-G-INJ-005 5. Particulate matter- Refer- G-INJ-001 6. Extractable volume-Refer-G-INJ-004 7. Assay: limit - NLT 95.0% and NMT 105.0% of the stated amount of
Lignocaine Hydrochloride and NLT 87.5% and NMT 112.5 % of the stated amount of Adrenaline.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 7, limit as per IP-2007.
LABELLING
The label states the strength of Adrenaline Bitartrate in terms of the equivalent amount of Adrenaline.
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D04005
Quality Control Department
Drug Name : Lignocaine Hydrochloride Injection Heavy IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 1302-1303
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
203
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. pH- limit 5.0 to 7.0, 4. 2,6,di methyl aniline 5. Sterility- Refer-G-INJ-005 6. Particulate matter- Refer- G-INJ-001 7. Clarity of solution-Refer-G-POW-003 8. Extractable volume- Refer- G-INJ-004 9. Assay: limit-95.0-105.0% of the stated amount of Lignocaine HCl.
ADDITIONAL TESTS
Nil
LIMITS
For test 1 to 8, limit as per IP-2007.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
200 Numbers.
SHELF LIFE
Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D04004
Quality Control Department
Drug Name : Lignocaine Hydrochloride Injection IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 1302-1303
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
204
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. pH- limit 5.0 to 7.0, 4. 2,6,di methyl aniline 5. Sterility- Refer-G-INJ-005 6. Particulate matter- Refer- G-INJ-001 7. Clarity of solution-Refer-G-POW-003 8. Extractable volume- Refer- G-INJ-004 9. Assay: limit-95.0-105.0% of the stated amount of Lignocaine HCl.
ADDITIONAL TESTS
Nil
LIMITS
For test 1 to 9, limit as per IP-2007.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
200 Numbers.
SHELF LIFE
Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D17034
Quality Control Department
Drug Name : Lorazepam Injection USP Page 1 of 1
Synonym : Copy No. 1
Official Standards : US Pharmacopoeia 2008, Volume 2, Page No. 2551-2552
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
205
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. BET- NMT 100.0 USP EU/MG of Lorazepam. 4. Related compounds 5. Sterility 6. Particulate matter 7. Volume in container 8. Assay: limit-90.0-110.0% of the labelled amount of Lorazepam.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 8, limit as per USP-2008.
LABELLING
Nil.
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D16007
Quality Control Department
Drug Name : Magnesium Sulphate Injection BP Page 1 of 1
Synonym : Copy No. 1
Official Standards : British Pharmacopoeia 2009, Volume 3, Page No. 2739-2740
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
206
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Acidity or Alkalinity-Ph-5.5 to 7.0,refer page no-A225 4. Particulate Contamination-sub visible particles 5. Sterility- refer page no-2245 6. Uniformity of dosage units, refer page no-2246 7. Assay: limit-95.0-105.0% of the stated amount of Magnesium sulphate hepta
hydrate.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 7, limit as per BP-2009.
LABELLING
1. Strength is stated as the percentage w/v of Magnesium sulphate Hepta-hydrate and as the approximate concentration of Magnesium ions (mg2+) in millimoles/ml.
2. name and concentration of any added anti-microbial preservative.
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D18010
Quality Control Department
Drug Name : Mannitol Injection IP Page 1 of 1
Synonym : Mannitol IV Infusion Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 3, Page No. 1652-1653
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
207
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. pH-Limit 4.5 to 7.0 4. Particulate Contamination-Refer-G-INF-002 5. BET-NMT 0.5EU/ML. 6. Sterility- Refer- G-INF-002. 7. Assay: limit-95.0-105.0% of the stated amount of Mannitol.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 7, limit as per IP-2007.
LABELLING
The label states; 1. The strength as a percentage w/v of Mannitol, 2. That the injection should not be used if it contains visible solid particles that
do not dissolve on warming.
QUANTITY REQUIRED FOR ANALYSIS
50 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D24010
Quality Control Department
Drug Name : Methotrexate Injection IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 1302-1303
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
208
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. pH- limit 7.5 to 9.0. 4. Particulate matter- Refer- G-INJ-001 5. Extractable volume- Refer- G-INJ-004 6. Sterility- Refer-G-INJ-005 7. Assay: limit-95.0-110.0% of the stated amount of Methotrexate.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 7, limit as per IP-2007.
LABELLING
The label states that the injections is not intended for intrathecal injection when an anti-microbial preservative is present.
QUANTITY REQUIRED FOR ANALYSIS
200 Numbers.
SHELF LIFE
Minimum 18 months
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D16004
Quality Control Department
Drug Name : Methyl Ergometrine Maleate Injection IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 1370-1371
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
209
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. pH- limit -2.7 to 3.5 determined in a solution containing the equivalent of
5.0 % wt/v of hydrocortisone 4. Related substance 5. Extractable volume. G-INJ-004 6. Sterility- refer-G-INJ-005 7. Particulate matter- Refer- G-INJ-001 8. Assay: limit-90.0-110.0% of the stated amount of Methyl Ergometrine
Maleate.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 8, limit as per IP-2007.
LABELLING
Nil.
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D05012
Quality Control Department
Drug Name : Methyl Prednisolone Sodium Succinate Injection USP Page 1 of 1
Synonym : Methyl Prednisolone Sodium Succinate for Injection Copy No. 1
Official Standards : US Pharmacopeia 2008, Volume 3, Page No. 2687-2688
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
210
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Constituted solution 4. BET- NMT 0.17 USP EU/MG of Methyl Prednisolone. 5. pH- limit 7.0 to 8.0. 6. Loss on drying-NMT 2.0% 7. Particulate matter 8. Free Methyl Prednisolone 9. Uniformity of dosage units. 10. Sterility 11. Assay: limit-90.0-115.0% of the labeled amount of Methyl Prednisolone.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 11, limit as per USP-2008.
LABELLING
Nil.
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D20005
Quality Control Department
Drug Name : Metoclopramide Injection IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 1379
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
211
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Appearance of the solution 4. pH- limit 3.0 to 5.0 5. Related substance 6. Sterility- Refer-G-INJ-005 7. Particulate matter- Refer- G-INJ-001 8. Extractable volume- Refer- G-INJ-004 9. Assay: Limit-90.0-110.0% of the stated amount of Anhydrous
Metoclopramide.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 9, limit as per IP-2007.
LABELLING
The label states the strength in terms of the equivalent amount of anhydrous Metoclopramide HCl in a suitable dose-volume.
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 18 months
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D13019
Quality Control Department
Drug Name : Metoprolol Injection BP Page 1 of 1
Synonym : Copy No. 1
Official Standards : British Pharmacopoeia 2009, Volume 3, Page No. 2772
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
212
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Acidity or Alkalinity, pH-Limit 5.5 to 7.5.Refer page-A225 4. Related substances-HPLC 5. Particulate Contamination-Sub visible particles. Refer page-2245 6. Uniformity of dosage units. Refer page-2246 7. Extractable volume 8. Sterility 9. Assay: Limit-95.0-105.0% of the stated amount.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 9, limit as per BP-2009.
LABELLING
Name and Concentration of any added antimicrobial preservatives.
QUANTITY REQUIRED FOR ANALYSIS
200 Numbers.
SHELF LIFE
Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D02025
Quality Control Department
Drug Name : Metronidazole Injection IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 1384
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
213
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. pH- limit 4.5 to 7.0. 4. BET- Not more than 0.35 EU/MG of Metronidazole. 5. Clarity of solution - Refer-G-POW-001 6. Extractable volume - Refer-G-INJ-004 7. Particulate matter - Refer- G-INJ-001 8. Sterility - Refer-G-INJ-005 9. Assay: Limit - 90.0-110.0% of the stated amount of Metronidazole.
ADDITIONAL TESTS
Nil
LIMITS
For test 1 to 9, limit as per IP-2007.
LABELLING
The label states that the contents should not be used if they contain any visible solid particle.
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D06007
Quality Control Department
Drug Name : Acetylcysteine Injection BP Page 1 of 1
Synonym : N-Acetylcysteine Injection Copy No. 1
Official Standards : British Pharmacopoeia 2009, Volume 3, Page No. 2267
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
214
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Acidity or Alkalinity.pH, Limit-6.5 to 7.5 4. Specific Optical rotation-Limit-+21 to +27 5. Related substances-HPLC 6. Hydrogen sulphide 7. Sterility 8. Particulate Contamination-sub visible particles 9. Uniformity of dosage units 10. Assay: Limit-95.0-105.0% of the stated amount of Acetylcysteine.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 10, limit as per BP-2009.
LABELLING
1. The strength is stated in terms of an equivalent % w/v of Acetylcysteine. 2. Name and concentration of any added anti-microbial preservatives
QUANTITY REQUIRED FOR ANALYSIS
200 Numbers.
SHELF LIFE
Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D06003
Quality Control Department
Drug Name : Naloxone Injection BP Page 1 of 1
Synonym : Copy No. 1
Official Standards : British Pharmacopoeia 2009, Volume 3, Page No. 2804
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
215
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Acidity-pH,Limit-3 To 4.5 4. Related substances 5. BET 6. Uniformity of dosage units 7. Sterility 8. Particulate Contamination-sub visible particles 9. Assay: limit-95.0-105.0% of the stated amount of Naloxone
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 9, limit as per BP-2009.
LABELLING
1. Name and concentration of any added antimicrobial preservatives. 2. Quantity of active ingredient is stated in terms of the equivalent amount of
anhydrous Naloxone Hydrochloride 3. When Naloxone is prescribed for neonatal use Neonatal Naloxone Injection
(Containing the equivalent of 20 micrograms /ml of anhydrous Naloxone hydrochloride) shall be dispensed.
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D04008
Quality Control Department
Drug Name : Neostigmine Methylsulphate Injection IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 3, Page No. 1432
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
216
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. pH- limit 4.0 to 6.5 4. 3-Hydroxy Trimethyl Anilinium Methyl Sulphate-HPLC 5. Sterility- Refer-G-INJ-005 6. Particulate matter- Refer- G-INJ-001 7. Uniformity of content- Refer- G-INJ-003 8. Extractable volume- Refer- G-INJ-004 9. Assay: limit-90.0-110.0% of the stated amount of Neostigmine
Methylsulphate.
ADDITIONAL TESTS
Nil
LIMITS
For test 1 to 9, limit as per IP-2007.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
200 Numbers.
SHELF LIFE
Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D13028
Quality Control Department
Drug Name : Nitroglycerin Injection USP Page 1 of 1
Synonym : Copy No. 1
Official Standards : US Pharmacopeia 2008, Volume 3, Page No. 2817-2818
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
217
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. BET- NMT 0.1 USP EU/microgram of Nitroglycerin. 4. pH-Limit,3.0 to 6.5 5. Particulate matter 6. Alcohol content-Limit 90.0 to 110.0% of the labelled amount of isopropyl
alcohol being used as the internal standard. 7. Sterility 8. Volume in container 9. Assay: limit-90.0-110.0% of the labeled amount of Nitroglycerin.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 9, limit as per USP-2008.
LABELLING
Where necessary, label it to indicate that it is to be diluted before use.
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D02018
Quality Control Department
Drug Name : Ofloxacin Injection IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 3, Page No. 1469
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
218
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. pH- limit 3.5 to 5.8, 4. Sterility- Refer-G-INJ-005 5. Particulate contamination- Refer- G-INJ-001 6. Assay: Limit - 90.0-120.0% of the stated amount of Ofloxacin. Note:- Ofloxacin Infusion Official As Per IP 2007
ADDITIONAL TESTS
Nil
LIMITS
For test 1 to 6, limit as per IP-2007.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D20014
Quality Control Department
Drug Name : Ondansetron Injection USP Page 1 of 1
Synonym : Copy No. 1
Official Standards : US Pharmacopeia 2008, Volume 3, Page No. 2856-2857
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
219
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. BET- NMT 9.9 USP EU/MG of Ondansetron Hydrochloride. 4. pH- limit 3.3 to 4.0,Refer USP page no-314 5. Particulate matter 6. Limit of Ondansetron related compound D 7. Chromatographic purity 8. Sterility 9. Volume in container 10. Assay: limit-95.0-105.0% of the labeled amount of Ondansetron.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 10, limit as per USP-2008.
LABELLING
Specify the route of administration.
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D16001
Quality Control Department
Drug Name : Oxytocin Injection IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 3, Page No. 1498-1499
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
220
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. pH- limit -3.5 to 4. 4. Particulate matter- Refer- G-INJ-001 5. Uniformity of content-Refer-G-INJ-003 6. Extractable volume. Refer- G-INJ-004 7. Sterility- Refer-G-INJ-005 8. Assay: limit-90.0-110.0% of the stated amount of units of Oxytocin activity.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 8, limit as per IP-2007.
LABELLING
The label states; 1. the number of units of Oxytocin activity/ml 2. either the animal species from which it is obtained or whether it is synthetic,
as appropriate.
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D24019
Quality Control Department
Drug Name : Paclitaxel Injection USP Page 1 of 1
Synonym : Copy No. 1
Official Standards : US Pharmacopeia 2007, Volume 3, Page No. 2901-2902
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
221
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. BET- NMT 0.67 USP EU/MG of Paclitaxel. 4. pH- Limit 3.0 to 7.0 5. Limit of degradation products. 6. Sterility 7. Foreign and Particulate matter 8. Volume in container 9. Assay: limit-90.0-110.0% of the labeled amount of Paclitaxel.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 9, limit as per USP-2008.
LABELLING
Label it to indicate that it is to be diluted with a suitable parenteral vehicle prior to intravenous infusion.
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D04009
Quality Control Department
Drug Name : Pancuronium Bromide Injection BP Page 1 of 1
Synonym : Copy No. 1
Official Standards : British Pharmacopoeia 2009, Volume 3, Page No. 2486
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
222
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Acidity-pH- limit 3.8 to 4.2-Refer page A-225 BP-2009 4. Related substances 5. Sterility- refer-G-INJ-005 6. Particulate contamination-sub visible particles, Refer- PAGE 2245 7. Uniformity of dosage units. 8. Assay: limit - 95.0-105.0% of the stated amount.
ADDITIONAL TESTS Nil.
LIMITS
For test 1 to 8, limit as per BP-2009.
LABELLING
Nominal volume of the contents – page 2247, name and concentration of any added antimicrobial preservatives.
QUANTITY REQUIRED FOR ANALYSIS
200 Numbers.
SHELF LIFE
Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D01009
Quality Control Department
Drug Name : Paracetamol Injection IP Page 1 of 1
Synonym : Acetaminophen Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 3.
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
223
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Sterility- Refer-G-INJ-005 4. Particulate matter- Refer- G-INJ-001 5. Extractable volume- Refer-G-INJ-004 6. Clarity of solution- Refer-G-POW-003 7. Assay: limit- 90.0-110.0% of the stated amount of Paracetamol.
ADDITIONAL TESTS
Nil
LIMITS
For test 1 to 7, limit as per IP-2007.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D01008
Quality Control Department
Drug Name : Pentazocine Lactate Injection IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 3, Page No. 1529-1530
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
224
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. pH – limit 4.0 to 5.0 4. Related substance 5. Sterility- refer-G-INJ-005 6. Particulate matter- refer- G-INJ-001 7. Extractable volume-refer-G-INJ-004 8. Clarity of solution-refer-G-POW-003 9. Assay: limit-95.0-105.0% of the stated amount of Pentazocine
ADDITIONAL TESTS
Nil
LIMITS
For test 1 to 9, limit as per IP-2007.
LABELLING
The label states the strength in terms of the equivalent amount of Pentazocine in a suitable volume.
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D07003
Quality Control Department
Drug Name : Phenobarbitone Sodium Injection IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 3, Page No. 1544
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
225
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. pH– Limit 10.0% to 11% 4. Particulate matter - Refer G-INJ-001 5. Extractable volume - Refer-G-INJ-004 6. Sterility – Refer G-INJ-005 7. Assay – NLT 95.0% and not more than 105.0% of the stated amount of
Phenobarbitone Sodium.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 7, limit as per IP-2007.
LABELLING
The label states that the injection should not be used if the solution is discoloured or if it contains precipitate.
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D07008
Quality Control Department
Drug Name : Phenytoin Sodium Injection BP Page 1 of 1
Synonym : Copy No. 1
Official Standards : British Pharmacopoeia 2009, Volume 3, Page No. 2879-2880
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
226
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Alkalinity pH-11.5 to 12.1 4. Weight /ml -1.025 to 1.035 gm 5. Benzil and Benzophenone 6. Ethanol – by Gas chromatography – 9.0 to 110% v/v 7. Proppyline glycol 37.0 to 43% v/v 8. Sterility – refer G-INJ-005 9. Particulate contamination : sub visible 10. Assay: limit-90.0-110.0% of the stated amount of Phenytoin Sodium.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 10, limit as per BP-2009.
LABELLING
Nil.
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D12005
Quality Control Department
Drug Name : Phytomenadione Injection BP Page 1 of 1
Synonym : Copy No. 1
Official Standards : British Pharmacopoeia 2009, Volume 3, Page No. 2882
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
227
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Acidity or Alkalinity-pH-5.0 to 7.5 4. Extractable volume 5. Particulate Contamination-sub visible particles 6. Sterility 7. Assay: limit-90.0-115.0% of the stated amount of Phytomenadione
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 7, limit as per BP-2009.
LABELLING
The label states that the injection should not be used if separation has occurred or if oil droplets have appeared.
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D18012
Quality Control Department
Drug Name : Potassium Chloride for Injection Concentrate USP Page 1 of 1
Synonym : Copy No. 1
Official Standards : US Pharmacopeia 2008, Volume 3, Page No. 3033
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
228
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. BET- Not more than 1.8 USP EU/MG of Bupivacaine Hydrochloride 4. pH- Limit 4.0 to 8.0. 5. Volume in container 6. Particulate matter 7. Sterility 8. Assay: limit-95.0 to 105.0 % of the labelled amount of Potassium chloride.
ADDITIONAL TESTS Nil.
LIMITS For test 1 to 8, limit as per USP-2008.
LABELLING
The label states Potassium chloride content in terms of weight and of m Eq in a given volume. Label the concentrate to indicate that it is to be diluted to approximate strength with water or other suitable fluid prior to administration. Immediately following the name, the label bears the boxed warning;
Concentrate Must Be Diluted Before Use Ampoules must be identified by a black band or a series of black bands above the constriction. The label states also the total osmolar concentration in m Osmol per Litre where the contents are less than 100 ml the label alternatively may state the total osmolar concentration in m Osmol per mL
QUANTITY REQUIRED FOR ANALYSIS 200 Numbers.
SHELF LIFE Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D06004
Quality Control Department
Drug Name : Pralidoxime Chloride Injection IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 3, Page No. 1579-1580
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
229
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. pH- limit 3.5 to 4.5,determined in a 5.0% wt/v solution. 4. Heavy metals 5. BET- Not more than 0.1 EU/MG of Pralidoxime chloride. 6. Uniformity of weight-Refer- G-POW-002 7. Clarity of solution-Refer-G-POW-003(of the constituted solution) 8. Sterility- Refer-G-POW-004 9. Particulate matter- Refer-G-POW-005 (of the constituted solution) 10. Assay: Limit-90.0-110.0% of the stated amount of Pralidoxime chloride
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 10, limit as per IP-2007.
LABELLING
The label states the period within which the constituted injection should be used.
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D05009
Quality Control Department
Drug Name : Promethazine Injection IP Page 1 of 1
Synonym : Promethazine Hydrochloride Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 3, Page No. 1604
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
230
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. pH- limit 5.0 to 6.0, 4. Related substances 5. Sterility- Refer-G-INJ-005 6. Extractable volume-Refer- G-INJ-004 7. Particulate matter- Refer- G-INJ-001 8. Assay: limit-95.0-105.0% of the stated amount of Promethazine HCl.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 8, limit as per IP-2007.
LABELLING
Nil.
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND MEDICINES Drug Code : D04010
Quality Control Department
Drug Name : Propofol Injection BP Page 1 of 1
Synonym : Copy No. 1
Official Standards : British Pharmacopoeia 2009, Volume 3, Page No. 2918
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
231
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Acidity or alkalinity-pH- limit 6.0 to 8.5 4. Propofol quinone and propofol dimer-HPLC 5. Sterility- Refer-G-INJ-005 6. Globule size 7. Free fatty acids 8. Lyso lecithin-HPLC 9. BET-page-2246,BP volume-3 10. Particulate contamination-sub visible particle 11. Uniformity of dosage units 12. Assay: limit-95.0-105.0% of the stated amount of propofol.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 12, limit as per BP-2009.
LABELLING
Name and concentrations of any added antimicrobial preservative.
QUANTITY REQUIRED FOR ANALYSIS
60 Numbers.
SHELF LIFE
Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D12012
Quality Control Department
Drug Name : Protamine Sulphate Injection IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 3, Page No. 1617
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
233
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. pH – limit 2.5 to 3.5 4. Optical rotation-limit 0.52°c to 0.68°c 5. Light absorption-Limit NMT 0.1 6. BET-NMT7.0EU/MG of Protamine sulphate. 7. Abnormal toxicity 8. Particulate matter- Refer- G-INJ-001 9. Uniformity of content-Refer-G--INJ-003 10. Sterility- Refer-G-INJ-005 11. Extractable volume-Refer-G-INJ-004 12. Assay: NLT 80.0% of the stated amount of Protamine sulphate.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 12, limit as per IP-2007.
LABELLING
1. States that dose is calculated from the results of the determinations of the
amount required to produce an acceptable blood clotting time in the patient 2. The approximate number of units of Heparin I ml is capable of neutralizing.
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D08010
Quality Control Department
Drug Name : Quinine Injection IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 3, Page No. 1637
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
234
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. pH- limit 1.5 to 3.0. 4. Other Cinchona alkaloids-HPLC 5. Extractable volume- Refer-G-INJ-004 6. Particulate matter- Refer- G-INJ-001 7. Sterility- Refer-G-INJ-005 8. Assay: Limit-95.0-105.0% of the stated amount of Quinine Dihydrochloride.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 8, limit as per IP-2007.
LABELLING
The label states that the solution must be diluted to a strength not exceeding 30mg/ml before administration and that care should be taken to ensure slow intravenous injection.
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D20001
Quality Control Department
Drug Name : Ranitidine Injection IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 3, Page No. 1652-1653
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
235
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. pH-Limit 6.7 to 7.3 4. Related substances 5. Particulate matter-Refer-G-INJ-001 6. Sterility- Refer- G-INJ-005. 7. Extractable volume- Refer- G-INJ-004. 8. Assay: limit-90.0-110.0% of the stated amount of Ranitidine.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 9, limit as per IP-2007.
LABELLING
The label states; 1. The strength in terms of the equivalent amount of ranitidine. 2. Where appropriate, that the injection is buffered.
QUANTITY REQUIRED FOR ANALYSIS
200 Numbers.
SHELF LIFE
Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D18009
Quality Control Department
Drug Name : Ringer Lactate Injection IP Page 1 of 1
Synonym : Compound Sodium Lactate IV infusion, Ringer Lactate solution for Injection, Hartmann’s solution for Injection.
Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 3, Page No. 1727-1728
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
236
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. pH-Limit 5.0 to 7.0 4. Particulate Contamination-Refer-G-INF-002 5. BET-NMT 0.5EU/ML. 6. Sterility- Refer- G-INF-002. 7. Assay: limit - Compound sodium Lactate injection contains 0.27%w/v to
0.32%w/v of sodium, 0.019%w/v to 0.022%w/v of potassium, 0.37 %w/v to 0.42%w/v of total chloride, 0.025%w/v to 0.029 %w/v of calcium chloride and 0.23%w/v to 0.28%w/v of lactate calculated as C3H6O3
ADDITIONAL TESTS Nil. LIMITS For test 1 to 7, limit as per IP-2007. LABELLING
The label states; 1. The injection contains in millimoles per litre the following approximate
amounts of the ions. Sodium 131, Potassium 5, Calcium 2, bicarbonate (as lactate) 29 and chloride111.
2. That the injection should not be used if the solution contains visible and solid particles.
QUANTITY REQUIRED FOR ANALYSIS 50 Numbers.
SHELF LIFE Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D06010
Quality Control Department
Drug Name : Sodium Calcium Edetate Injection BP Page 1 of 1
Synonym : Sodium Calcium Edetate IV Infusion Copy No. 1
Official Standards : British Pharmacopoeia 2009, Volume 3, Page No. 2960
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
237
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Acidity or Alkalinity, pH-Limit 6.5 to 8.0 4. Sterility 5. Particulate Contamination-Sub visible particles. 6. Uniformity of dosage units. 7. Assay: Limit-19.0-21.0%w/v of the anhydrous Sodium Calcium Edetate.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 7, limit as per BP-2009.
LABELLING
1. Strength is stated as the equivalent amount of anhydrous sodium calcium edetate in a suitable dose-volume.
2. Sterile sodium calcium edentate concentrate 3. Solution must be diluted with Sodium chloride I.V infusion or Glucose I.V
infusion before administration. 4. Name and Concentration of any added antimicrobial preservatives.
QUANTITY REQUIRED FOR ANALYSIS
200 Numbers.
SHELF LIFE
Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D18002
Quality Control Department
Drug Name : Sodium Chloride 0.9% & Dextrose 5.0% w/v IP Page 1 of 1
Synonym : Sodium Chloride & Dextrose Infusion, Copy No. 1 Sodium Chloride and Glucose IV Infusion
Official Standards : Indian Pharmacopoeia 2007, Volume 3, Page No. 1710
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
238
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. pH-Limit 3.5 to 6.5 4. 5-Hydroxy methyl furfural and related substances 5. Particulate Contamination-Refer-G-INF-002 6. BET-NMT 10.0EU/Gram of Dextrose. 7. Particulate contamination. - Refer- G-INF-001. 8. Sterility- Refer- G-INF-002. 9. Assay: 95.0 to 105.0 % 0f the stated amount of Sodium chloride and
Dextrose.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 9, limit as per IP-2007.
LABELLING
The label states; 1. The strength as the percentages w/v of sodium chloride and Dextrose 2. That a solution containing visible particles must not be used. 3. When the preparation is intended for intravenous infusion, the label states the
approximate concentrations, in millimoles per litre, of the sodium and chloride ions and the number of grams per litre of Dextrose
QUANTITY REQUIRED FOR ANALYSIS
50 Numbers. SHELF LIFE Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D18001
Quality Control Department
Drug Name : Sodium Chloride Injection IP 0.9%w/v Page 1 of 1
Synonym : Sodium Chloride I.V Infusion Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 3, Page No. 1712-1713
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
239
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. pH-Limit 4.5 to 7.0 4. Heavy metals-Limit 0.3ppm 5. Particulate Contamination-Refer-G-INF-002 6. BET-NMT 0.5EU/ML. 7. Sterility- Refer- G-INF-002. 8. Assay: NLT 0.85%w/v and NMT 0.95 %w/v of Sodium chloride.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 8, limit as per IP-2007.
LABELLING
The label states; 1. The strength as a percentage w/v of Sodium chloride 2. That a solution containing visible solid particles must not be used. 3. Label states that the injection contains approximate 150 millimoles each of
Sodium and Chloride ions per litre.
QUANTITY REQUIRED FOR ANALYSIS
50 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D13025
Quality Control Department
Drug Name : Sodium Nitroprusside Injection USP Page 1 of 1
Synonym : Copy No. 1
Official Standards : US Pharmacopeia 2008, Volume 3, Page No. 3255
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
240
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. BET- NMT 0.05 USP EU/microgram of sodium Nitroprusside. Refer USP Page no-98 4. Water-NMT15.0%, Refer USP page no-370 5. Sterility 6. Uniformity of dosage unit- Refer USP-2008,page no-363 7. Foreign & Particulate matter- ReferUSP-2008,page no-36 8. Constituted solution- (a) completeness and clarity of solution
(b) particulate matter 9. Assay: limit-90.0-110.0% of the stated amount of Sodium Nitroprusside
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 9, limit as per USP-2008.
LABELLING
As per USP specification.
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D06012
Quality Control Department
Drug Name : Sodium Thiosulphate Injection BP Page 1 of 1
Synonym : Copy No. 1
Official Standards : British Pharmacopoeia 2007, Volume 3, Page No. 2974
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
241
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Acidity or Alkalinity, pH-Limit 7.0 to 9.0 4. Sterility 5. Particulate Contamination-Sub visible particles. 6. Uniformity of dosage units. 7. Assay: Limit-95.0-105.0% of the stated amount.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 7, limit as per BP-2009.
LABELLING
Name and Concentration of any added antimicrobial preservatives.
QUANTITY REQUIRED FOR ANALYSIS
200 Numbers.
SHELF LIFE
Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D18011
Quality Control Department
Drug Name : Sterile Water for Injection IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 3, Page No. 1870
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
242
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Appearance of the solution 3. Acidity or Alkalinity 4. Ammonium 5. Calcium and Magnesium 6. Heavy metals 7. Chlorides 8. Nitrates 9. Sulphates 10. Oxidisable substances 11. Residue on evaporation 12. Particulate contamination- Refer- G-INJ-002. 13. BET 14. Sterility- Refer- G-INJ-005.
ADDITIONAL TESTS Nil. LIMITS For test 1 to 14, limit as per IP-2007.
LABELLING Nil. QUANTITY REQUIRED FOR ANALYSIS
200 Numbers.
SHELF LIFE Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D13022
Quality Control Department
Drug Name : Streptokinase Injection IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 1755
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
243
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. pH- Limit 6.8 to 7.5, determined on a freshly constituted injection containing
5000 units /ml. 4. Streptodornase 5. Streptolysin 6. BET 7. Uniformity of weight-Refer- G-POW-002 8. Clarity of solution-Refer-G-POW-003(of the constituted solution) 9. Particulate matter- Refer- G-POW-005 (of the constituted solution) 10. Sterility- Refer-G- POW-004 11. Assay: limit-90.0-111.0% of the stated potency.
ADDITIONAL TESTS Nil. LIMITS
For test 1 to 11, limit as per IP-2007.
LABELLING The label states the total number of units of streptokinase activity contained in it.
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D04013
Quality Control Department
Drug Name : Succinyl Choline Injection IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 3, Page No. 1760
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
244
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. pH- limit 3.0 to 5.0 4. Hydrolysis product 5. Sterility- refer-G-INJ-005 6. Particulate matter-. refer-G-INJ-001 7. Extractable volume- refer-G-INJ-004 8. Assay: limit-90.0-107.5% of the stated amount of Succinyl Choline Chloride.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 8, limit as per IP-2007.
LABELLING
Nil.
QUANTITY REQUIRED FOR ANALYSIS
50 Numbers.
SHELF LIFE
Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D03007
Quality Control Department
Drug Name : Terbutaline Injection IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 3, Page No. 1788
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
245
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Uniformity of content-refer G-INJ-003 4. pH- limit 3.0 to 5.0, 5. BET- not more than 0.15 EU/MG of Ampicillin. 6. Sterility- refer-G-INJ-005 7. Water-not more than 2.0 % determined on 0.3grams. 8. Particulate matter- refer- G-INJ-001 9. Extractable volume- refer- G-INJ-004 10. Assay: limit-90.0-110.0% of the stated amount of Terbutaline.
ADDITIONAL TESTS
Nil
LIMITS
For test 1 to 10, limit as per IP-2007.
LABELLING
The label states that the injection should not be used if the solution is discoloured.
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D21009
Quality Control Department
Drug Name : Tetanus Toxoid Injection IP Page 1 of 1
Synonym : Tetanus vaccine (Adsorbed) Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 3, Page No. 1992
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
246
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Aluminium - Maximum 1.25 mg per single human use if Aluminium Hydroxide
or hydrated Aluminium phosphate is used as the adsorbent. 4. Free Formaldehyde-Maximum 0.2g/1 5. Antimicrobial preservative - NLT 85.0% and NMT 115.0 % 0f the intended
amount (where applicable) 6. Sterility - Refer-G-INJ-005 7. Abnormal toxicity 8. Potency of Tetanus component. 9. Extractable volume- Refer-G-INJ-004 10. Assay: The lower confidence limit of estimated potency shall not be less than
40.0 IU/SHD. ADDITIONAL TESTS Nil. LIMITS For test 1 to 10, limit as per IP-2007. LABELLING
The label states; 1. Human dose (ml), 2. Minimum units per single human use or the minimum IU per single human dose
if potency test done by challenge method or both, 3. The name and the amount of the adsorbent and preservatives, 4. That the vaccine must be shaken before use, 5. That the vaccine is not to be frozen.
QUANTITY REQUIRED FOR ANALYSIS 100 Numbers. SHELF LIFE Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D03001
Quality Control Department
Drug Name : Theophylline and Etophylline Injection Page 1 of 1
Synonym : Copy No. 1
Official Standards :
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
247
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Sterility- Refer-G-INJ-005 4. Particulate matter - Refer- G-INJ-001 5. Clarity of solution - Refer-G-POW-003 6. Extractable volume - Refer-G-INJ-004 7. Assay: limit - 90.0-1110.0% of the stated amount of Theophylline and
Etophylline.
ADDITIONAL TESTS
Nil
LIMITS
For test 1 to 7, limit as per IP-2007.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D04014
Quality Control Department
Drug Name : Thiopentone Sodium Injection IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 3, Page No. 1803
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
248
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Appearance of solution 4. Related substances 5. Loss on drying 6. Uniformity of weight-Refer-G-POW-002 7. Clarity of solution-Refer-G-POW-003 8. Sterility- Refer-G-INJ-004 9. Particulate matter-. Refer-G-POW-005 10. Assay: Thiopentone injection contains Thiopentone, that is not less than
77.0% and not more than 92.0% and sodium that is not less than 9.4% and not more than 11.8% of the stated amount of Thiopentone sodium.
ADDITIONAL TESTS Nil. LIMITS For test 1 to 8, limit as per IP-2007. LABELLING
The label states the amount of active ingredient in terms of Thiopentone Sodium
QUANTITY REQUIRED FOR ANALYSIS 100 Numbers. SHELF LIFE Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D01011
Quality Control Department
Drug Name : Tramadol Injection IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 3, Page No.
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
249
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Sterility- Refer-G-INJ-005 4. Particulate matter- Refer- G-INJ-001 5. Extractable volume - Refer-G-INJ-004 6. Assay: limit- 90.0-110.0% of the stated amount of Tramadol Hydrochloride.
ADDITIONAL TESTS
Nil
LIMITS
For test 1 to 6, limit as per IP-2007.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D02027
Quality Control Department
Drug Name : Vancomycin Hydrochloride Injection Page 1 of 1
Synonym : Copy No. 1
Official Standards : US Pharmacopoeia 2008, Volume 3, Page No. 3501
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
250
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Uniformity of weight - Refer G-POW-002 4. pH- limit 8.0 to 10.0, determined in10 minutes after dissolution in 10%w/v
solution. 5. Heavy metals - not more than 0.003% 6. BET - not more than 0.33usp EU/MG of Vancomycin. 7. Sterility - Refer-G-INJ-005 8. Chromatographic purity - Refer USP page-3501 9. Particulate matter - Refer- G-INJ-001 (of the constituted solution) and
USP-2008, page no-37 10. Completeness and clarity of solution-refer-G-POW-003 (of the constituted
solution) and USP-2008, page no-37 11. Assay: limit - 90.0-115.0% of the stated amount of Vancomycin.
ADDITIONAL TESTS Nil LIMITS
For test 1 to 11, limit as per USP-2008.
LABELLING Volume of the diluents to be added should be specified.
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D04020
Quality Control Department
Drug Name : Vecuronium Bromide Injection Page 1 of 1
Synonym : Copy No. 1
Official Standards : KMSCL In-house Method
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
251
TESTS AS PER OFFICIAL MONOGRAPH
6. Description. 7. Identification. 8. Sterility- Refer-G-INJ-005 9. Particulate matter- Refer- G-INJ-001 10. Extractable volume-Refer-G-INJ-004 11. Clarity of solution-Refer-G-POW-003 12. Uniformity of content-Refer-G-INJ-003 13. BET-NMT10EU/mg of Vecuronium Bromide. 14. Sterility-Refer-G-INJ-005 15. Assay: limit-90.0-110.0% of the stated amount of Vecuronium Bromide.
ADDITIONAL TESTS Nil. LIMITS For test 1 to 10, limit as per KMSCL In-house Method. LABELLING Nil. QUANTITY REQUIRED FOR ANALYSIS 100 Numbers. SHELF LIFE Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D24002
Quality Control Department
Drug Name : Vincristine Sulphate Injection IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 3, Page No. 1857-1858
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
252
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Appearance of solution 4. pH-Limit 3.5 to 5.0,determined in a solution containing0.15%w/v solution of
the dried contents 5. Related substances 6. BET-NMT 62.5 EU/mg of dried Vincristine sulphate. 7. Particulate matter-Refer-G-INJ-001 8. Uniformity of weight/Uniformity of content- Refer-G-INJ-001 9. Sterility- Refer- G-INJ-005. 10. Assay: limit-90.0-110.0% of the stated amount of Vincristine Sulphate.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 10, limit as per IP-2007.
LABELLING
The label states; 1. the strength in terms of the weight of dried Vincristine sulphate, 2. the names of auxiliary substances if any, 3. that the contents are to be used by IV only, 4. the storage conditions.
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers. SHELF LIFE Minimum 2 years.
253
KKEE
RRAA
LLAA
MM
EEDD
II CCAA
LL
SSEE
RRVV
II CCEE
SS
CCOO
RRPP
OORR
AATT
II OONN
LL
TTDD
MMEEDDIICCAALL DDEEVVIICCEESS
QQuuaalliittyy CCoonnttrrooll MMaannuuaall FFoorr
DDrruuggss AAnndd SSuupppplliieess
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : S27007
Quality Control Department
Drug Name : Absorbent Cotton Wool IP Page 1 of 1
Synonym : Absorbent Cotton Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 970&971
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
254
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Identification 3. Acidity or Alkalinity 4. Surface active substances 5. Absorbency 6. Foreign fibres 7. Fluorescence 8. Colouring matter 9. Ether soluble substances 10. Water soluble substances 11. Neps 12. Sulphated ash 13. Loss on drying
ADDITIONAL TESTS Nil. LIMITS
For tests 1 to 13, limits as per IP
QUANTITY REQUIRED FOR ANALYSIS
2 units
SHELF LIFE
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : S27002
Quality Control Department
Drug Name : Adhesive Tape U.S.P. 10 cm x 5 m JR – roll Page 1 of 1
Synonym : Copy No. 1
Official Standards : US Pharmacopeia 2008, Volume 3, Page No. 3322
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
255
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Dimensions. 3. Tensile Strength. 4. Adhesive Strength. 5. Sterility: (If sterile)
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 5, limit as per USP-2008.
LABELLING
The package label of tape that has been renderd sterile indicates that the contents may not be sterile if the package bears evidence of damage or previously ha been opened. The package label indicates the length and width of the tape and the name of the manufacturer, packer or distributor.
QUANTITY REQUIRED FOR ANALYSIS
SHELF LIFE
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : S27104 to
S27107 Quality Control Department
Drug Name : Black Braided Silk 1-25 M (Reels) Null Box of 6 Reels Page 1 of 1
Synonym : Copy No. 1
Official Standards : US Pharmacopeia 2008, Volume 3, Page No. 3314-3317
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
257
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Length: Limit - not less than 95.0% of the length stated on the label. 3. Diameter : Limit – Ref. Table 4 4. Tensile Strength : Ref. Table 4 5. Sterility (If claimed sterile) 6. Needle attachment : Ref. SUT Table 5 6 7. Soluble chromium compounds 8. Extractable colour : Ref. SUT Table 3
ADDITIONAL TESTS
Nil.
LIMITS
AS per the reference.
LABELLING
As per USP 2008 Vol. 3 p. 3316 given under non absorbable surgical suture.
QUANTITY REQUIRED FOR ANALYSIS
60 Numbers.
SHELF LIFE
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : S27108
Quality Control Department
Drug Name : Black Silk 5-0 ½ C 17 mm Needle Taper cut 76 cm. NULL Box of 12 Page 1 of 1
Synonym : Copy No. 1
Official Standards : US Pharmacopeia 2008, Volume 3, Page No. 3314-3317
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
258
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Length: Limit – Not less than 95.0 percent of the length stated in the label. 3. Diameter : Limit – Ref. SUT Table 4 4. Tensile strength : Ref. SUT Table 4 5. Needle attachment : Ref. SUT Table 5 & 6 6. Sterility : (If claimed sterile) 7. Extractable colour : Limit - Ref. SUT Table 3 8. Soluble chromium compound: Limit – Colour extracted should be less
intense than the colour of the standard solution.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 8, limit as per USP-2008.
LABELLING
As per USP 2008, Vol. 3, Page 3316 given under non absorbable surgical suture.
QUANTITY REQUIRED FOR ANALYSIS
30 + 30 Numbers.
SHELF LIFE
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : S27014 to
S27021 Quality Control Department
Drug Name : BP Blade – 10 / 11 / 15 / 20 / 21 / 22 / 23 / 24 Page 1 of 1
Synonym : Copy No. 1
Official Standards : KMSCL In-house Specifications
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
259
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Identification : 3. Nominal Volume 4. Extractable Volume 5. PH (5.0 – 6.0) 6. Bacterial Endotoxins : Not more than 5.56 EU/ml 7. Chloride : Not more than 0.0035% 8. Sterility 9. Particulate matter 10. Assay : Limit – It contains in each 100 ml, not less than 2.11 g and not more
than 2.33 g of monobasic sodium phosphate, not less than 30.30 g and not more than 33.50 g of dextrose, not less than 19.16 g and not more than 21.18 g, of total citrate, expressed as citric acid anhydrous, not less than 6.21 g and not more than 6.86 g of sodium, and not less than 0.247 g and not more than 0.303 g of adenine
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 10, limit as per USP-2008.
LABELLING
Label it to indicate the number of ml of solution required per 100ml of whole blood or the number of ml of solution required per volume of whole blood to be collected.
QUANTITY REQUIRED FOR ANALYSIS
30 + 30 Numbers.
SHELF LIFE
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : S27014 to
S27021 Quality Control Department
Drug Name : BP Blade – 10 / 11 / 15 / 20 / 21 / 22 / 23 / 24 Page 1 of 1
Synonym : Copy No. 1
Official Standards : KMSCL In-house Specifications
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
260
TESTS AS PER OFFICIAL MONOGRAPH
Physico Chemical Testing:
1. Surface Finish
2. Corrosion Test
3. Limits for acidity and alkalinity as per ISO - 9626: 2001.
Biological Testing:
4. Sterility
5. Pyrogen Test / BET
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 5, limit as per KMSCL In-house Specifications.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : S27184
Quality Control Department
Drug Name : Braided Poly Glycolic Acid Suture 1 150cm without Needle Page 1 of 1
Synonym : Copy No. 1
Official Standards : US Pharmacopeia 2008, Volume 3, Page No. 3314-3317
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
261
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Length: Limit not less than 95.0% of the length stated on the label. 3. Diameter : Ref. SUT Table II 4. Tensile Strength : Ref. SUT Table II 5. Needle attachment : Ref. SUT Table V & VI 6. Sterility : If sterile 7. Extractable colour (If dyed) : Ref. SUT Table III 8. Soluble Chromium Compounds: Limit colour extracted should be loss
intense than the colour of the standard solution.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 8, limit as per USP-2008.
LABELLING
As per USP 2008, Volume 3, Page 3316, given under non absorbable surgical suture.
QUANTITY REQUIRED FOR ANALYSIS
30 + 30 Numbers.
SHELF LIFE
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : S27183
Quality Control Department
Drug Name : Braided Poly Glycolic Acid Suture 1-0 150cm without Needle Page 1 of 1
Synonym : Copy No. 1
Official Standards : US Pharmacopeia 2008, Volume 3, Page No. 3314-3317
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
262
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Length: Limit not less than 95.0% of the length stated on the label. 3. Diameter : Ref. SUT Table II 4. Tensile Strength : Ref. SUT Table II 5. Needle attachment : Ref. SUT Table V & VI 6. Sterility : If sterile 7. Extractable colour (If dyed) : Ref. SUT Table III 8. Soluble Chromium Compounds: Limit colour extracted should be loss
intense than the colour of the standard solution.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 8, limit as per USP-2008.
LABELLING
As per USP 2008, Volume 3, Page 3316, given under non absorbable surgical suture.
QUANTITY REQUIRED FOR ANALYSIS
30 + 30 Numbers.
SHELF LIFE
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : S27179
Quality Control Department
Drug Name : Braided Poly Glycolic Acid Suture 1-0 90cm ½ Circle Taper Cut Page 1 of 1
Synonym : Copy No. 1
Official Standards : US Pharmacopeia 2008, Volume 3, Page No. 3314-3317
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
263
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Length: Limit not less than 95.0% of the length stated on the label. 3. Diameter : Ref. SUT Table II 4. Tensile Strength : Ref. SUT Table II 5. Needle attachment : Ref. SUT Table V & VI 6. Sterility : If sterile 7. Extractable colour (If dyed) : Ref. SUT Table III 8. Soluble Chromium Compounds: Limit colour extracted should be loss
intense than the colour of the standard solution.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 8, limit as per USP-2008.
LABELLING
As per USP 2008, Volume 3, Page 3316, given under non absorbable surgical suture.
QUANTITY REQUIRED FOR ANALYSIS
30 + 30 Numbers.
SHELF LIFE
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : S27177
Quality Control Department
Drug Name : Braided Poly Glycolic Acid Suture 190 cm ½ Circle Taper Cut (Heavy) 40mm Page 1 of 1
Synonym : Copy No. 1
Official Standards : US Pharmacopeia 2008, Volume 3, Page No. 3314-3317
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
264
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Length: Limit not less than 95.0% of the length stated on the label. 3. Diameter : Ref. SUT Table II 4. Tensile Strength : Ref. SUT Table II 5. Needle attachment : Ref. SUT Table V & VI 6. Sterility : If sterile 7. Extractable colour (If dyed) : Ref. SUT Table III 8. Soluble Chromium Compounds: Limit colour extracted should be loss
intense than the colour of the standard solution.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 8, limit as per USP-2008.
LABELLING
As per USP 2008, Volume 3, Page 3316, given under non absorbable surgical suture.
QUANTITY REQUIRED FOR ANALYSIS
30 + 30 Numbers.
SHELF LIFE
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : S27182
Quality Control Department
Drug Name : Braided Poly Glycolic Acid Suture 2-0 150cm without Needle Page 1 of 1
Synonym : Copy No. 1
Official Standards : US Pharmacopeia 2008, Volume 3, Page No. 3314-3317
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
265
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Length: Limit not less than 95.0% of the length stated on the label. 3. Diameter : Ref. SUT Table II 4. Tensile Strength : Ref. SUT Table II 5. Needle attachment : Ref. SUT Table V & VI 6. Sterility : If sterile 7. Extractable colour (If dyed) : Ref. SUT Table III 8. Soluble Chromium Compounds: Limit colour extracted should be loss
intense than the colour of the standard solution.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 8, limit as per USP-2008.
LABELLING
As per USP 2008, Volume 3, Page 3316, given under non absorbable surgical suture.
QUANTITY REQUIRED FOR ANALYSIS
30 + 30 Numbers.
SHELF LIFE
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : S27178
Quality Control Department
Drug Name : Braided Poly Glycolic Acid Suture 2-0 90cm ½ Circle Reverse Cutting 40mm Page 1 of 1
Synonym : Copy No. 1
Official Standards : US Pharmacopeia 2008, Volume 3, Page No. 3314-3317
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
266
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Length: Limit not less than 95.0% of the length stated on the label. 3. Diameter : Ref. SUT Table II 4. Tensile Strength : Ref. SUT Table II 5. Needle attachment : Ref. SUT Table V & VI 6. Sterility : If sterile 7. Extractable colour (If dyed) : Ref. SUT Table III 8. Soluble Chromium Compounds: Limit colour extracted should be loss
intense than the colour of the standard solution.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 8, limit as per USP-2008.
LABELLING
As per USP 2008, Volume 3, Page 3316, given under non absorbable surgical suture.
QUANTITY REQUIRED FOR ANALYSIS
30 + 30 Numbers.
SHELF LIFE
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : S27180
Quality Control Department
Drug Name : Braided Poly Glycolic Acid Suture 3-0 45cm 3/8 Circle Reverse Cutting 12mm Page 1 of 1
Synonym : Copy No. 1
Official Standards : US Pharmacopeia 2008, Volume 3, Page No. 3314-3317
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
267
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Length: Limit not less than 95.0% of the length stated on the label. 3. Diameter : Ref. SUT Table II 4. Tensile Strength : Ref. SUT Table II 5. Needle attachment : Ref. SUT Table V & VI 6. Sterility : If sterile 7. Extractable colour (If dyed) : Ref. SUT Table III 8. Soluble Chromium Compounds: Limit colour extracted should be loss
intense than the colour of the standard solution.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 8, limit as per USP-2008.
LABELLING
As per USP 2008, Volume 3, Page 3316, given under non absorbable surgical suture.
QUANTITY REQUIRED FOR ANALYSIS
30 + 30 Numbers.
SHELF LIFE
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : S27109
Quality Control Department
Drug Name : Catgut Atraumatic No. IRB 63 mm Blunt Needle Null Box of 12. Page 1 of 1
Synonym : Copy No. 1
Official Standards : US Pharmacopeia 2008, Volume 3, Page No. 3314-3317
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
268
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Length: Limit – Not less than 95.0 percent of the length stated in the label. 3. Diameter : Limit – Ref. SUT Table 4 4. Tensile strength : Ref. SUT Table 4 5. Needle attachment : Ref. SUT Table 5 & 6 6. Sterility : (If claimed sterile) 7. Extractable colour : Limit - Ref. SUT Table 3 8. Soluble chromium compound: Limit – Colour extracted should be less
intense than the colour of the standard solution.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 8, limit as per USP-2008.
LABELLING
As per USP 2008, Vol. 3, Page 3316 given under non absorbable surgical suture.
QUANTITY REQUIRED FOR ANALYSIS
30 + 30 Numbers.
SHELF LIFE
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : S27120& S27121 Quality Control Department
Drug Name : Catgut Atromatic RB. Page 1 of 1
Synonym : Copy No. 1
Official Standards : British Pharmacopoeia 2009, Volume 3, Page No. 3309
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
269
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Length: Limit – The length of each suture is not less than 90% of the length
stated on the label and does not exceed 350 cm 3. Diameter: Limit – Ref. SUT Table I 4. Minimum Breaking Load – Ref. SUT Table I 5. Soluble chromium compounds: The solution is not more intensely coloured
than the standard solution (IPPM of Cr) 6. Needle Attachment: Ref SUT Table 5 & 6 7. Extractable colour : Ref. SUT Table 3 8. Sterility.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 8, limit as per BP-2009.
LABELLING
1. Gauge Number 2. Length in cm or m 3. If appropriate, that the needle is detachable 4. Name of the product 5. Intended use
QUANTITY REQUIRED FOR ANALYSIS
SHELF LIFE
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : S27122
Quality Control Department
Drug Name : Catgut Chromic 1 – 0, RB, 3/8 circle 76 cm, 45mm Page 1 of 1
Synonym : Copy No. 1
Official Standards : British Pharmacopoeia 2009, Volume 3, Page No. 3309
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
270
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Length: Limit – The length of each suture is not less than 90% of the length
stated on the label and does not exceed 350 cm 3. Diameter: Limit – Ref. SUT Table I 4. Minimum Breaking Load – Ref. SUT Table I 5. Soluble chromium compounds: The solution is not more intensely coloured
than the standard solution (IPPM of Cr) 6. Needle Attachment: Ref SUT Table 5 & 6 7. Extractable colour : Ref. SUT Table 3 8. Sterility.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 8, limit as per BP-2009.
LABELLING
6. Gauge Number 7. Length in cm or m 8. If appropriate, that the needle is detachable 9. Name of the product 10. Intended use
QUANTITY REQUIRED FOR ANALYSIS
SHELF LIFE
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : S27110 & S27111 Quality Control Department
Drug Name : Catgut Chromic 1-0 152 cm Null (Box of 12) Page 1 of 1
Synonym : Copy No. 1
Official Standards : US Pharmacopeia 2008, Volume 3, Page No. 3314-3317
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
271
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Length: Limit – Not less than 95.0 percent of the length stated in the label. 3. Diameter : Limit – Ref. SUT Table 4 4. Tensile strength : Ref. SUT Table 4 5. Needle attachment : Ref. SUT Table 5 & 6 6. Sterility : (If claimed sterile) 7. Extractable colour : Limit - Ref. SUT Table 3 8. Soluble chromium compound: Limit – Colour extracted should be less
intense than the colour of the standard solution.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 8, limit as per USP-2008.
LABELLING
As per USP 2008, Vol. 3, Page 3316 given under non absorbable surgical suture.
QUANTITY REQUIRED FOR ANALYSIS
30 + 30 Numbers.
SHELF LIFE
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : S27112
Quality Control Department
Drug Name : Catgut Chromic 2-0 ½ CRB 30mm Needle 76 cm Null Box of 12 Page 1 of 1
Synonym : Copy No. 1
Official Standards : US Pharmacopeia 2008, Volume 3, Page No. 3314-3317
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
272
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Length: Limit – Not less than 95.0 percent of the length stated in the label. 3. Diameter : Limit – Ref. SUT Table 4 4. Tensile strength : Ref. SUT Table 4 5. Needle attachment : Ref. SUT Table 5 & 6 6. Sterility : (If claimed sterile) 7. Extractable colour : Limit - Ref. SUT Table 3 8. Soluble chromium compound: Limit – Colour extracted should be less
intense than the colour of the standard solution.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 8, limit as per USP-2008.
LABELLING
As per USP 2008, Vol. 3, Page 3316 given under non absorbable surgical suture.
QUANTITY REQUIRED FOR ANALYSIS
30 + 30 Numbers.
SHELF LIFE
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : S27113 to
S27115 Quality Control Department
Drug Name : Catgut Chromic 2-0 ½ CRB 30mm Needle 76 cm Null Box of 12 Page 1 of 1
Synonym : Copy No. 1
Official Standards : US Pharmacopeia 2008, Volume 3, Page No. 3314-3317
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
273
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Length: Limit – Not less than 95.0 percent of the length stated in the label. 3. Diameter : Limit – Ref. SUT Table 4 4. Tensile strength : Ref. SUT Table 4 5. Needle attachment : Ref. SUT Table 5 & 6 6. Sterility : (If claimed sterile) 7. Extractable colour : Limit - Ref. SUT Table 3 8. Soluble chromium compound: Limit – Colour extracted should be less
intense than the colour of the standard solution.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 8, limit as per USP-2008.
LABELLING
As per USP 2008, Vol. 3, Page 3316 given under non absorbable surgical suture.
QUANTITY REQUIRED FOR ANALYSIS
30 + 30 Numbers.
SHELF LIFE
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : S27116& S27117 Quality Control Department
Drug Name : Catgut with Needle Page 1 of 1
Synonym : Copy No. 1
Official Standards : US Pharmacopeia 2008, Volume 3, Page No. 3314-3317
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
274
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Length: Limit – Not less than 95.0 percent of the length stated in the label. 3. Diameter : Limit – Ref. SUT Table 4 4. Tensile strength : Ref. SUT Table 4 5. Needle attachment : Ref. SUT Table 5 & 6 6. Sterility : (If claimed sterile) 7. Extractable colour : Limit - Ref. SUT Table 3 8. Soluble chromium compound: Limit – Colour extracted should be less
intense than the colour of the standard solution.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 8, limit as per USP-2008.
LABELLING
As per USP 2008, Vol. 3, Page 3316 given under non absorbable surgical suture.
QUANTITY REQUIRED FOR ANALYSIS
30 + 30 Numbers.
SHELF LIFE
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : S27118& S27119 Quality Control Department
Drug Name : Catgut Plain BP Page 1 of 1
Synonym : Copy No. 1
Official Standards : British Pharmacopoeia 2009, Volume 3, Page No. 3309
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
275
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Length: Limit – The length of each suture is not less than 90% of the length
stated on the label and does not exceed 350 cm 3. Diameter: Limit – Ref. SUT Table I 4. Minimum Breaking Load – Ref. SUT Table I 5. Soluble chromium compounds: The solution is not more intensely odoured
than the standard solution (IPPM of Cr) 6. Needle Attachment: Ref SUT Table 5 & 6 7. Extractable colour : Ref. SUT Table 3 8. Sterility
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 8, limit as per BP-2009.
LABELLING
11. Gauge Number 12. Length in cm or m 13. If appropriate, that the needle is detachable 14. Name of the product 15. Intended use
QUANTITY REQUIRED FOR ANALYSIS
SHELF LIFE
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : S27025 to
S27030 Quality Control Department
Drug Name : Disposable Needle 18 G Page 1 of 1
Synonym : Copy No. 1
Official Standards : IS 10654 : 2002, ISO 7864 : 1993
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
276
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Appearance 3. Cleanliness 4. Limits for acidity or alkalinity 5. Limits for extractable metals 6. Size designation 7. Colour of hub 8. Sheath 9. Length of needle 10. Needle point 11. Bond between hub and needle tube 12. Potency of lumen 13. Packaging 14. Sterility
LIMITS- For tests 1 to 14, limit as per IS 10654 : 2002, ISO 7864 : 1993 LABELLING
i) Primary Container 1. A description of the contents, including the designated metric size 2. The word “STERILE” 3. The lot number, prefixed by the word “LOT” 4. The name or trade mark or trade name or logo of the manufacturer or supplier ii) Secondary Container 1. A description of the contents, including the designated metric size 2. The word “STERILE” 3. The lot number, prefixed by the word “LOT” 4. The number, the type or angle of bevels, if appropriate, the words “thin-walled” or “extra-thin-walled” or
equivalent or an abbreviation. 5. The words “For SINGLE 6. USE” or equivalent 7. A warning to check the integrity of each primary container before use. 8. The date of sterilization 9. The name and address of the manufacturer or supplier 10. Information for handling storage and transportation iii) Storage Container 1. Description of the contents 2. The lot number, prefixed by the word “LOT” 3. The word “STERILE” 4. The date of sterilization 5. The name and address of the manufacturer or supplier 6. Information for handling, storage and transportation of the contents.
QUANTITY REQUIRED FOR ANALYSIS-100 numbers SHELF LIFE
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : S27100
Quality Control Department
Drug Name : Disposable Surgeon Is Mask (Double Layer) Page 1 of 1
Synonym : Copy No. 1
Official Standards : KMSCL In-house Specifications
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
277
TESTS AS PER OFFICIAL MONOGRAPH
1. Description :
2. Length :
3. Length of Tie Bands :
4. Colour :
5. Strength of Joint :
6. Numbers of Bands :
7. Sterility :
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 7, limit as per KMSCL In-house Specifications.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : S27031to S27033 Quality Control Department
Drug Name : Disposable Syringe Without Needle 2cc Page 1 of 1
Synonym : Copy No. 1
Official Standards : British Pharmacopoeia 2009, Volume 4, Page No. A485
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
278
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Capacity. 3. Appearance of solution. 4. Acidity or alkalinity. 5. Absorbance: Does not exceed 0.4 6. Ethylene Oxide: (G.C.) Limit not greater than 10 ppm 7. Reducing substances. 8. Transparency. 9. Sterility.
ADDITIONAL TESTS Nil.
LIMITS For test 1 to 8, limit as per BP-2009.
LABELLING
Label on the package states : 1. Batch number 2. Description of the syringe’ 3. That the syringe is fro single – use only
Label on the outer package states : 1. The method of sterilisation 2. That the syringe is sterile or that if is sterile only internally 3. The identity of the manufacturer 4. That the syringe is not to be used if the packaging is damaged or the sterility
protector is loose.
QUANTITY REQUIRED FOR ANALYSIS
SHELF LIFE
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : S27045 to
S27053 Quality Control Department
Drug Name : Endo Tracheal Tube Page 1 of 1
Synonym : Copy No. 1
Official Standards : KMSCL In-house Specifications
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
279
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Tip : 3. Length : ± 5mm 4. I.D. (Inner diameter) : ± .015mm 5. O.D. (Outer diameter) : ± 0.15mm 6. Component Fitting : 7. Marking : 8. Radio Opaque Line : Present / Absent 9. Strength of Joint : 10. Leakage Test : 11. Sterility : 12. Chemical Test :
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 12, limit as per KMSCL In-house Specifications.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : S27054 to
S27061 Quality Control Department
Drug Name : Endotracheal Tube 5.5 with Cuff Page 1 of 1
Synonym : Copy No. 1
Official Standards : KMSCL In-house Specifications
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
280
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Tip : 3. Length : ± 5mm 4. I.D. (Inner diameter) : ± .015mm 5. O.D. (Outer diameter) : ± 0.15mm 6. Component Fitting : 7. Marking : 8. Radio Opaque Line : Present / Absent 9. Colour: 10. Balloon: 11. Value 12. Strength of Joint : 13. Leakage Test : 14. Leakage of Secondary Tube: 15. Sterility : 16. Chemical Test :
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 16, limit as per KMSCL In-house Specifications.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code :
S27062 to S27067& S27193 Quality Control Department
Drug Name : Folley’s Catheter Page 1 of 1
Synonym : Copy No. 1
Official Standards : KMSCL In-house Specifications
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
281
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Total Appearance 3. Functional Testing 4. Physical Testing 5. Intracutaneous Reactivity 6. Undue Toxicity 7. Sterility
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 7, limit as per KMSCL In-house Specifications.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : S27069 to
S27074 Quality Control Department
Drug Name : Infant Feeding Tube 4F Page 1 of 1
Synonym : Copy No. 1
Official Standards : KMSCL In-house Specifications
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
282
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Tip 3. Eye 4. Length ± 10mm 5. O.D ± .15mm 6. Component Fitting 7. Marking 8. Radio Opaque Line 9. Colour 10. Chemical Test 11. Sterility
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 11, limit as per KMSCL In-house Specifications.
STORAGE
Nil
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : S27211
Quality Control Department
Drug Name : Insulin Syringe with Fixed Needle 29G (1ml) Page 1 of 1
Synonym : Copy No. 1
Official Standards : IS : 12227-1987
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
284
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Capacity of syringes 3. Graduation scale 4. Numbering of scale 5. Barrel 6. Piston / plunger Assembly 7. Size of Needle 8. Performance of Assembled syringe 9. Nozzle 10. Freedom from Extraneous matter 11. Limits for extractable matter 12. Lubrication of syringes and needles 13. Sterility 14. Bacterial Endotoxin : Less than 20 Eu/device
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 11, limit as per IS: 12227-1987.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : S27167
Quality Control Department
Drug Name : Monofilament poly amide 10/0 CS – ultima ½ Circle double Needle 6mm Page 1 of 1
Synonym : Copy No. 1
Official Standards : US Pharmacopeia 2008, Volume 3, Page No. 3314-3317
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
285
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Length: Limit not less than 95.0% of the length stated on the label. 3. Diameter : Ref. SUT Table II 4. Tensile Strength : Ref. SUT Table II 5. Needle attachment : Ref. SUT Table V & VI 6. Sterility : If sterile 7. Extractable colour (If dyed) : Ref. SUT Table III 8. Soluble Chromium Compounds: Limit colour extracted should be loss
intense than the colour of the standard solution.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 8, limit as per USP-2008.
LABELLING
As per USP 2008, Volume 3, Page 3316, given under non absorbable surgical suture.
QUANTITY REQUIRED FOR ANALYSIS
30 + 30 Numbers.
SHELF LIFE
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : S27168
Quality Control Department
Drug Name : Monofilament Poly Amide 10/0 CS – ultima 3/8 Circle double Needle 6mm Page 1 of 1
Synonym : Copy No. 1
Official Standards : US Pharmacopeia 2008, Volume 3, Page No. 3314-3317
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
286
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Length: Limit not less than 95.0% of the length stated on the label. 3. Diameter : Ref. SUT Table II 4. Tensile Strength : Ref. SUT Table II 5. Needle attachment : Ref. SUT Table V & VI 6. Sterility : If sterile 7. Extractable colour (If dyed) : Ref. SUT Table III 8. Soluble Chromium Compounds: Limit colour extracted should be loss
intense than the colour of the standard solution.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 8, limit as per USP-2008.
LABELLING
As per USP 2008, Volume 3, Page 3316, given under non absorbable surgical suture.
QUANTITY REQUIRED FOR ANALYSIS
30 + 30 Numbers.
SHELF LIFE
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : S27176
Quality Control Department
Drug Name : Monofilament Poly Propylene Blue 3-0 70cm 3/8 Circle Cutting 22mm Page 1 of 1
Synonym : Copy No. 1
Official Standards : US Pharmacopeia 2008, Volume 3, Page No. 3314-3317
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
287
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Length: Limit not less than 95.0% of the length stated on the label. 3. Diameter : Ref. SUT Table II 4. Tensile Strength : Ref. SUT Table II 5. Needle attachment : Ref. SUT Table V & VI 6. Sterility : If sterile 7. Extractable colour (If dyed) : Ref. SUT Table III 8. Soluble Chromium Compounds: Limit colour extracted should be loss
intense than the colour of the standard solution.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 8, limit as per USP-2008.
LABELLING
As per USP 2008, Volume 3, Page 3316, given under non absorbable surgical suture.
QUANTITY REQUIRED FOR ANALYSIS
30 + 30 Numbers.
SHELF LIFE
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : S27175
Quality Control Department
Drug Name : Monofilament Poly Propylene Blue 170cm ½ CRB (Heavy) 40mm Page 1 of 1
Synonym : Copy No. 1
Official Standards : US Pharmacopeia 2008, Volume 3, Page No. 3314-3317
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
288
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Length: Limit not less than 95.0% of the length stated on the label. 3. Diameter : Ref. SUT Table II 4. Tensile Strength : Ref. SUT Table II 5. Needle attachment : Ref. SUT Table V & VI 6. Sterility : If sterile 7. Extractable colour (If dyed) : Ref. SUT Table III 8. Soluble Chromium Compounds: Limit colour extracted should be loss
intense than the colour of the standard solution.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 8, limit as per USP-2008.
LABELLING
As per USP 2008, Volume 3, Page 3316, given under non absorbable surgical suture.
QUANTITY REQUIRED FOR ANALYSIS
30 + 30 Numbers.
SHELF LIFE
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : S27174
Quality Control Department
Drug Name : Monofilament Poly Propylene Blue 1-0 70cm ½ CRB 30mm Page 1 of 1
Synonym : Copy No. 1
Official Standards : US Pharmacopeia 2008, Volume 3, Page No. 3314-3317
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
289
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Length: Limit not less than 95.0% of the length stated on the label. 3. Diameter : Ref. SUT Table II 4. Tensile Strength : Ref. SUT Table II 5. Needle attachment : Ref. SUT Table V & VI 6. Sterility : If sterile 7. Extractable colour (If dyed) : Ref. SUT Table III 8. Soluble Chromium Compounds: Limit colour extracted should be loss
intense than the colour of the standard solution.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 8, limit as per USP-2008.
LABELLING
As per USP 2008, Volume 3, Page 3316, given under non absorbable surgical suture.
QUANTITY REQUIRED FOR ANALYSIS
30 + 30 Numbers.
SHELF LIFE
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : S27169
Quality Control Department
Drug Name : Monofilament polyamide 8/0 ½ circle reverse cutting micro point 8mm Page 1 of 1
Synonym : Copy No. 1
Official Standards : US Pharmacopeia 2008, Volume 3, Page No. 3314-3317
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
290
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Length: Limit not less than 95.0% of the length stated on the label. 3. Diameter : Ref. SUT Table II 4. Tensile Strength : Ref. SUT Table II 5. Needle attachment : Ref. SUT Table V & VI 6. Sterility : If sterile 7. Extractable colour (If dyed) : Ref. SUT Table III 8. Soluble Chromium Compounds: Limit colour extracted should be loss
intense than the colour of the standard solution.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 8, limit as per USP-2008.
LABELLING
As per USP 2008, Volume 3, Page 3316, given under non absorbable surgical suture.
QUANTITY REQUIRED FOR ANALYSIS
30 + 30 Numbers.
SHELF LIFE
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : S27172
Quality Control Department
Drug Name : Non- Adherent Sterile Rayon Dressing Impregnated with 10 Povidone Iodine size 10 x 10cm Page 1 of 1
Synonym : Copy No. 1
Official Standards : KMSCL In-house Specification
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
291
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Fibre Identification : (Shall comply with test for viscore)
3. Thread / 10cm : Courses NLT 76 - NMT 145, Wales NLT 60 - NMT 85
4. Weight / Unit Area of Fabric : NLT 150g/m2 – NMT 210g/m2
5. Content of Ointment on Dressing in g: 3.00g ± 0.50g.
6. Assay - Povidone Iodine Content: 10.00% w/w ± 2.00% w/w % w/w.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 8, limit as per USP-2008.
LABELLING
As per USP 2008, Volume 3, Page 3316, given under non absorbable surgical suture.
QUANTITY REQUIRED FOR ANALYSIS
30 + 30 Numbers.
SHELF LIFE
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code :
S27203, S27204 & S27205 Quality Control Department
Drug Name : Oxygen Catheter 8F / 10F/ 12F Page 1 of 1
Synonym : Copy No. 1
Official Standards : KMSCL In-house Specifications
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
292
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Physical test 3. Tip 4. Eye 5. Total Length : ± 10mm 6. Effective length : ± 10mm 7. O.D : ± 1mm 8. Component Fitting 9. Marking 10. Radio Opaque Line 11. Colour 12. Chemical test 13. Sterility
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 13, limit as per KMSCL In-house Specifications.
LABELLING
Ref IP/USP/IHS
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : S27012
Quality Control Department
Drug Name : Paediatric Bag Page 1 of 1
Synonym : Copy No. 1
Official Standards : US Pharmacopeia 2008, Volume 2, Page No. 1431-1432
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
293
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Identification : 3. Nominal Volume 4. Extractable Volume 5. PH (5.0 – 6.0) 6. Bacterial Endotoxins : Not more than 5.56 EU/ml 7. Chloride : Not more than 0.0035% 8. Sterility 9. Particulate matter 10. Assay : Limit – It contains in each 100 ml, not less than 2.11 g and not more
than 2.33 g of monobasic sodium phosphate, not less than 30.30 g and not more than 33.50 g of dextrose, not less than 19.16 g and not more than 21.18 g, of total citrate, expressed as citric acid anhydrous, not less than 6.21 g and not more than 6.86 g of sodium, and not less than 0.247 g and not more than 0.303 g of adenine
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 10, limit as per USP-2008.
LABELLING
Label it to indicate the number of ml of solution required per 100ml of whole blood or the number of ml of solution required per volume of whole blood to be collected.
QUANTITY REQUIRED FOR ANALYSIS
30 + 30 Numbers.
SHELF LIFE
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : S27001
Quality Control Department
Drug Name : Plaster of Paris Bandages BP 15 cm x 2.7m Page 1 of 1
Synonym : Copy No. 1
Official Standards : British Pharmacopoeia 1988, Volume 2, Page No. 1113
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
294
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Fibre Identification 3. Threads per 10 cm – (Warp 143 to 157 weft – 71 to 79) 4. Weight per amt area – (Fabric not less than 24 gm per m2, bandage not less
than 340 gm per m2) 5. Calcium sulphate hemihydrate - Not less than 88% of the calcium sulphate
content calculated as Calcium sulphate Hemi hydrate 6. Setting Time – The plaster mass remains work role for not less than Iminate
after removal if bandage freom water and not should be set after 8 mts. When removed from the mandival cast should not evaluable and the pressure of the fingers.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 6, limit as per BP-1988.
LABELLING
QUANTITY REQUIRED FOR ANALYSIS
5 + 5 Rolls
SHELF LIFE
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : S27128
Quality Control Department
Drug Name : Poliglecarpone 25 (Dyed) Size 1/0 with Round Body Needle For Anastamosis Page 1 of 1
Synonym : Copy No. 1
Official Standards : US Pharmacopeia 2008, Volume 3, Page No. 3314-3317
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
295
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Length: Limit not less than 95.0% of the length stated on the label. 3. Diameter : Ref. SUT Table II 4. Tensile Strength : Ref. SUT Table II 5. Needle attachment : Ref. SUT Table V & VI 6. Sterility : If sterile 7. Extractable colour (If dyed) : Ref. SUT Table III 8. Soluble Chromium Compounds: Limit colour extracted should be loss
intense than the colour of the standard solution.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 8, limit as per USP-2008.
LABELLING
As per USP 2008, Vol. 3, Page 3316 given under non absorbable surgical suture.
QUANTITY REQUIRED FOR ANALYSIS
30 + 30 Numbers.
SHELF LIFE
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : S27130
Quality Control Department
Drug Name : Poliglecarpone 25 (Dyed) Size 2/0 with Black JB Shaped Round Body Needle For Anastamosis Page 1 of 1
Synonym : Copy No. 1
Official Standards : US Pharmacopeia 2008, Volume 3, Page No. 3314-3317
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
296
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Length: Limit not less than 95.0% of the length stated on the label. 3. Diameter : Ref. SUT Table II 4. Tensile Strength : Ref. SUT Table II 5. Needle attachment : Ref. SUT Table V & VI 6. Sterility : If sterile 7. Extractable colour (If dyed) : Ref. SUT Table III 8. Soluble Chromium Compounds: Limit colour extracted should be loss
intense than the colour of the standard solution.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 8, limit as per USP-2008.
LABELLING
As per USP 2008, Volume 3, Page 3316, given under non absorbable surgical suture.
QUANTITY REQUIRED FOR ANALYSIS
30 + 30 Numbers.
SHELF LIFE
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : S27129
Quality Control Department
Drug Name : Poliglecarpone 25 (Dyed) Size 2/0 with Round Body Needle For Anastamosis Page 1 of 1
Synonym : Copy No. 1
Official Standards : US Pharmacopeia 2008, Volume 3, Page No. 3314-3317
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
297
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Length: Limit not less than 95.0% of the length stated on the label. 3. Diameter : Ref. SUT Table II 4. Tensile Strength : Ref. SUT Table II 5. Needle attachment : Ref. SUT Table V & VI 6. Sterility : If sterile 7. Extractable colour (If dyed) : Ref. SUT Table III 8. Soluble Chromium Compounds: Limit colour extracted should be loss
intense than the colour of the standard solution.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 8, limit as per USP-2008.
LABELLING
As per USP 2008, Vol. 3, Page 3316 given under non absorbable surgical suture.
QUANTITY REQUIRED FOR ANALYSIS
30 + 30 Numbers.
SHELF LIFE
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : S27132
Quality Control Department
Drug Name : Poliglecarpone 25 (Dyed) Size 3/0 with Black JB Shaped For Anastamosis Page 1 of 1
Synonym : Copy No. 1
Official Standards : US Pharmacopeia 2008, Volume 3, Page No. 3314-3317
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
298
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Length: Limit not less than 95.0% of the length stated on the label. 3. Diameter : Ref. SUT Table II 4. Tensile Strength : Ref. SUT Table II 5. Needle attachment : Ref. SUT Table V & VI 6. Sterility : If sterile 7. Extractable colour (If dyed) : Ref. SUT Table III 8. Soluble Chromium Compounds: Limit colour extracted should be loss
intense than the colour of the standard solution.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 8, limit as per USP-2008.
LABELLING
As per USP 2008, Volume 3, Page 3316, given under non absorbable surgical suture.
QUANTITY REQUIRED FOR ANALYSIS
30 + 30 Numbers.
SHELF LIFE
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : S27131
Quality Control Department
Drug Name : Poliglecarpone 25 (Dyed) Size 3/0 with Cutting Needle For Subcuticular Suturing Page 1 of 1
Synonym : Copy No. 1
Official Standards : US Pharmacopeia 2008, Volume 3, Page No. 3314-3317
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
299
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Length: Limit not less than 95.0% of the length stated on the label. 3. Diameter : Ref. SUT Table II 4. Tensile Strength : Ref. SUT Table II 5. Needle attachment : Ref. SUT Table V & VI 6. Sterility : If sterile 7. Extractable colour (If dyed) : Ref. SUT Table III 8. Soluble Chromium Compounds: Limit colour extracted should be loss
intense than the colour of the standard solution.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 8, limit as per USP-2008.
LABELLING
As per USP 2008, Volume 3, Page 3316, given under non absorbable surgical suture.
QUANTITY REQUIRED FOR ANALYSIS
30 + 30 Numbers.
SHELF LIFE
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : S27125
Quality Control Department
Drug Name : Poliglecarpone 25 Size 1/0 with Round Body Needle For Anastamosis Page 1 of 1
Synonym : Copy No. 1
Official Standards : US Pharmacopeia 2008, Volume 3, Page No. 3314-3317
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
300
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Length : Limit not less than 95.0% of the length stated on the label 3. Diameter : Ref. SUT Table II 4. Tensile Strength : Ref. SUT Table II 5. Needle attachment : Ref. SUT Table V & VI 6. Sterility : If sterile 7. Extractable colour (If dyed) : Ref. SUT Table III 8. Soluble Chromium Compounds: Limit colour extracted should be loss
intense than the colour of the standard solution.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 8, limit as per USP-2008.
LABELLING
As per USP 2008, Vol. 3, Page 3316 given under non absorbable surgical suture.
QUANTITY REQUIRED FOR ANALYSIS
30 + 30 Numbers.
SHELF LIFE
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : S27126
Quality Control Department
Drug Name : Poliglecarpone 25 Size 2/0 with Round Body Needle For Anastamosis Page 1 of 1
Synonym : Copy No. 1
Official Standards : US Pharmacopeia 2008, Volume 3, Page No. 3314-3317
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
301
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Length : Limit not less than 95.0% of the length stated on the label. 3. Diameter : Ref. SUT Table II 4. Tensile Strength : Ref. SUT Table II 5. Needle attachment : Ref. SUT Table V & VI 6. Sterility : If sterile 7. Extractable colour (If dyed) : Ref. SUT Table III 8. Soluble Chromium Compounds: Limit colour extracted should be loss
intense than the colour of the standard solution.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 8, limit as per USP-2008.
LABELLING
As per USP 2008, Vol. 3, Page 3316 given under non absorbable surgical suture.
QUANTITY REQUIRED FOR ANALYSIS
30 + 30 Numbers.
SHELF LIFE
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : S27187
Quality Control Department
Drug Name : Polydioxanone of Size 1 with ½ Circle RB, heavy 50mm needle Suture Length 1.5m, For Sheath Closure Page 1 of 1
Synonym : Copy No. 1
Official Standards : US Pharmacopeia 2008, Volume 3, Page No. 3314-3317
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
302
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Length: Limit not less than 95.0% of the length stated on the label. 3. Diameter : Ref. SUT Table II 4. Tensile Strength : Ref. SUT Table II 5. Needle attachment : Ref. SUT Table V & VI 6. Sterility : If sterile 7. Extractable colour (If dyed) : Ref. SUT Table III 8. Soluble Chromium Compounds: Limit colour extracted should be loss
intense than the colour of the standard solution.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 8, limit as per USP-2008.
LABELLING
As per USP 2008, Volume 3, Page 3316, given under non absorbable surgical suture.
QUANTITY REQUIRED FOR ANALYSIS
30 + 30 Numbers.
SHELF LIFE
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : S27186
Quality Control Department
Drug Name : Polyglactin 910 of Size 1, ½ Circle 40mm CT Needle made of Special Grade Steal for 420 with Ribbed Body for Secure Grip
Page 1 of 1
Synonym : Copy No. 1
Official Standards : US Pharmacopeia 2008, Volume 3, Page No. 3314-3317
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
303
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Length: Limit not less than 95.0% of the length stated on the label. 3. Diameter : Ref. SUT Table II 4. Tensile Strength : Ref. SUT Table II 5. Needle attachment : Ref. SUT Table V & VI 6. Sterility : If sterile 7. Extractable colour (If dyed) : Ref. SUT Table III 8. Soluble Chromium Compounds: Limit colour extracted should be loss
intense than the colour of the standard solution.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 8, limit as per USP-2008.
LABELLING
As per USP 2008, Volume 3, Page 3316, given under non absorbable surgical suture.
QUANTITY REQUIRED FOR ANALYSIS
30 + 30 Numbers.
SHELF LIFE
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : S27188
Quality Control Department
Drug Name : Polyglactin 910 of Size 1, ½ Circle 36mm OB Needle made of special grade Steal 420 with ribbed body for secure grip
Page 1 of 1
Synonym : Copy No. 1
Official Standards : US Pharmacopeia 2008, Volume 3, Page No. 3314-3317
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
304
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Length: Limit not less than 95.0% of the length stated on the label. 3. Diameter : Ref. SUT Table II 4. Tensile Strength : Ref. SUT Table II 5. Needle attachment : Ref. SUT Table V & VI 6. Sterility : If sterile 7. Extractable colour (If dyed) : Ref. SUT Table III 8. Soluble Chromium Compounds: Limit colour extracted should be loss
intense than the colour of the standard solution.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 8, limit as per USP-2008.
LABELLING
As per USP 2008, Volume 3, Page 3316, given under non absorbable surgical suture.
QUANTITY REQUIRED FOR ANALYSIS
30 + 30 Numbers.
SHELF LIFE
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : S27189
Quality Control Department
Drug Name : Polyglactin 910 of Size 1-0, ½ Circle 36mm OB needle made of special grade steel 420 with ribbed body for secure grip
Page 1 of 1
Synonym : Copy No. 1
Official Standards : US Pharmacopeia 2008, Volume 3, Page No. 3314-3317
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
305
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Length: Limit not less than 95.0% of the length stated on the label. 3. Diameter : Ref. SUT Table II 4. Tensile Strength : Ref. SUT Table II 5. Needle attachment : Ref. SUT Table V & VI 6. Sterility : If sterile 7. Extractable colour (If dyed) : Ref. SUT Table III 8. Soluble Chromium Compounds: Limit colour extracted should be loss
intense than the colour of the standard solution.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 8, limit as per USP-2008.
LABELLING
As per USP 2008, Volume 3, Page 3316, given under non absorbable surgical suture.
QUANTITY REQUIRED FOR ANALYSIS
30 + 30 Numbers.
SHELF LIFE
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : S27185
Quality Control Department
Drug Name : Polyglactin 910 Rapid Size 2/0 with Taper Needle For Episiotomy Repair Page 1 of 1
Synonym : Copy No. 1
Official Standards : US Pharmacopeia 2008, Volume 3, Page No. 3314-3317
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
306
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Length: Limit not less than 95.0% of the length stated on the label. 3. Diameter : Ref. SUT Table II 4. Tensile Strength : Ref. SUT Table II 5. Needle attachment : Ref. SUT Table V & VI 6. Sterility : If sterile 7. Extractable colour (If dyed) : Ref. SUT Table III 8. Soluble Chromium Compounds: Limit colour extracted should be loss
intense than the colour of the standard solution.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 8, limit as per USP-2008.
LABELLING
As per USP 2008, Volume 3, Page 3316, given under non absorbable surgical suture.
QUANTITY REQUIRED FOR ANALYSIS
30 + 30 Numbers.
SHELF LIFE
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : S27176
Quality Control Department
Drug Name : Monofilament Poly Propylene Blue 3-0 70cm 3/8 Circle Cutting 22mm Page 1 of 1
Synonym : Copy No. 1
Official Standards : US Pharmacopeia 2008, Volume 3, Page No. 3314-3317
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
307
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Length: Limit not less than 95.0% of the length stated on the label. 3. Diameter : Ref. SUT Table II 4. Tensile Strength : Ref. SUT Table II 5. Needle attachment : Ref. SUT Table V & VI 6. Sterility : If sterile 7. Extractable colour (If dyed) : Ref. SUT Table III 8. Soluble Chromium Compounds: Limit colour extracted should be loss
intense than the colour of the standard solution.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 8, limit as per USP-2008.
LABELLING
As per USP 2008, Volume 3, Page 3316, given under non absorbable surgical suture.
QUANTITY REQUIRED FOR ANALYSIS
30 + 30 Numbers.
SHELF LIFE
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : S27157
Quality Control Department
Drug Name : Poly Glycolic Acid 1-0, Round Body, ½ Circle, 40mm, 150cm Page 1 of 1
Synonym : Copy No. 1
Official Standards : US Pharmacopeia 2008, Volume 3, Page No. 3314-3317
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
308
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Length: Limit not less than 95.0% of the length stated on the label. 3. Diameter : Ref. SUT Table II 4. Tensile Strength : Ref. SUT Table II 5. Needle attachment : Ref. SUT Table V & VI 6. Sterility : If sterile 7. Extractable colour (If dyed) : Ref. SUT Table III 8. Soluble Chromium Compounds: Limit colour extracted should be loss
intense than the colour of the standard solution.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 8, limit as per USP-2008.
LABELLING
As per USP 2008, Volume 3, Page 3316, given under non absorbable surgical suture.
QUANTITY REQUIRED FOR ANALYSIS
30 + 30 Numbers.
SHELF LIFE
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : S27158
Quality Control Department
Drug Name : Poly Glycolic Acid 2-0, Taper Cut, ½ Circle, 30mm, 90cm Page 1 of 1
Synonym : Copy No. 1
Official Standards : US Pharmacopeia 2008, Volume 3, Page No. 3314-3317
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
309
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Length: Limit not less than 95.0% of the length stated on the label. 3. Diameter : Ref. SUT Table II 4. Tensile Strength : Ref. SUT Table II 5. Needle attachment : Ref. SUT Table V & VI 6. Sterility : If sterile 7. Extractable colour (If dyed) : Ref. SUT Table III 8. Soluble Chromium Compounds: Limit colour extracted should be loss
intense than the colour of the standard solution.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 8, limit as per USP-2008.
LABELLING
As per USP 2008, Volume 3, Page 3316, given under non absorbable surgical suture.
QUANTITY REQUIRED FOR ANALYSIS
30 + 30 Numbers.
SHELF LIFE
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : S27155
Quality Control Department
Drug Name : Poly Glycolic Acid No. 1, ½ Circle, 40mm, 90cm Page 1 of 1
Synonym : Copy No. 1
Official Standards : US Pharmacopeia 2008, Volume 3, Page No. 3314-3317
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
310
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Length: Limit not less than 95.0% of the length stated on the label. 3. Diameter : Ref. SUT Table II 4. Tensile Strength : Ref. SUT Table II 5. Needle attachment : Ref. SUT Table V & VI 6. Sterility : If sterile 7. Extractable colour (If dyed) : Ref. SUT Table III 8. Soluble Chromium Compounds: Limit colour extracted should be loss
intense than the colour of the standard solution.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 8, limit as per USP-2008.
LABELLING
As per USP 2008, Volume 3, Page 3316, given under non absorbable surgical suture.
QUANTITY REQUIRED FOR ANALYSIS
30 + 30 Numbers.
SHELF LIFE
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : S27124
Quality Control Department
Drug Name : Poly Glycolic Acid Size 2/0 with Double Armed Needle for Episiotomy Page 1 of 1
Synonym : Copy No. 1
Official Standards : US Pharmacopeia 2008, Volume 3, Page No. 3314-3317
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
311
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Length : Limit not less than 95.0% of the length stated on the label 3. Diameter : Ref. SUT Table II 4. Tensile Strength : Ref. SUT Table II 5. Needle attachment : Ref. SUT Table V & VI 6. Sterility : If sterile 7. Extractable colour (If dyed) : Ref. SUT Table III 8. Soluble Chromium Compounds: Limit colour extracted should be loss
intense than the colour of the standard solution.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 8, limit as per USP-2008.
LABELLING
As per USP 2008, Vol. 3, Page 3316 given under non absorbable surgical suture.
QUANTITY REQUIRED FOR ANALYSIS
30 + 30 Numbers.
SHELF LIFE
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : S27164
Quality Control Department
Drug Name : Poly Glycolic Acid with Calcium Stearate Size 01 with 36mm Reverse Cutting Ortho Special (O.S) Needle
Page 1 of 1
Synonym : Copy No. 1
Official Standards : US Pharmacopeia 2008, Volume 3, Page No. 3314-3317
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
312
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Length: Limit not less than 95.0% of the length stated on the label. 3. Diameter : Ref. SUT Table II 4. Tensile Strength : Ref. SUT Table II 5. Needle attachment : Ref. SUT Table V & VI 6. Sterility : If sterile 7. Extractable colour (If dyed) : Ref. SUT Table III 8. Soluble Chromium Compounds: Limit colour extracted should be loss
intense than the colour of the standard solution.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 8, limit as per USP-2008.
LABELLING
As per USP 2008, Volume 3, Page 3316, given under non absorbable surgical suture.
QUANTITY REQUIRED FOR ANALYSIS
30 + 30 Numbers.
SHELF LIFE
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : S27162
Quality Control Department
Drug Name : Poly Glycolic Acid with Calcium Stearate Size 5/0 with ethiprime Cutting 12mm Page 1 of 1
Synonym : Copy No. 1
Official Standards : US Pharmacopeia 2008, Volume 3, Page No. 3314-3317
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
313
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Length: Limit not less than 95.0% of the length stated on the label. 3. Diameter : Ref. SUT Table II 4. Tensile Strength : Ref. SUT Table II 5. Needle attachment : Ref. SUT Table V & VI 6. Sterility : If sterile 7. Extractable colour (If dyed) : Ref. SUT Table III 8. Soluble Chromium Compounds: Limit colour extracted should be loss
intense than the colour of the standard solution.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 8, limit as per USP-2008.
LABELLING
As per USP 2008, Volume 3, Page 3316, given under non absorbable surgical suture.
QUANTITY REQUIRED FOR ANALYSIS
30 + 30 Numbers.
SHELF LIFE
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : S27161
Quality Control Department
Drug Name : Poly Glycolic Acid with Calcium Stearate Size 6/0 with Micropoint Spatulate 8mm Page 1 of 1
Synonym : Copy No. 1
Official Standards : US Pharmacopeia 2008, Volume 3, Page No. 3314-3317
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
314
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Length: Limit not less than 95.0% of the length stated on the label. 3. Diameter : Ref. SUT Table II 4. Tensile Strength : Ref. SUT Table II 5. Needle attachment : Ref. SUT Table V & VI 6. Sterility : If sterile 7. Extractable colour (If dyed) : Ref. SUT Table III 8. Soluble Chromium Compounds: Limit colour extracted should be loss
intense than the colour of the standard solution.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 8, limit as per USP-2008.
LABELLING
As per USP 2008, Volume 3, Page 3316, given under non absorbable surgical suture.
QUANTITY REQUIRED FOR ANALYSIS
30 + 30 Numbers.
SHELF LIFE
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : S27136 t0
S27141 Quality Control Department
Drug Name : Poly Propylene 1, ½ CRB 30 mm needle Hoary 75cm Page 1 of 1
Synonym : Copy No. 1
Official Standards : US Pharmacopeia 2008, Volume 3, Page No. 3314-3317
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
315
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Length: Limit – Not less than 95.0 percent of the length stated in the label. 3. Diameter : Limit – Ref. SUT Table 4 4. Tensile strength : Ref. SUT Table 4 5. Needle attachment : Ref. SUT Table 5 & 6 6. Sterility : (If claimed sterile) 7. Extractable colour : Limit - Ref. SUT Table 3 8. Soluble chromium compound: Limit – Colour extracted should be less
intense than the colour of the standard solution.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 8, limit as per USP-2008.
LABELLING
As per USP 2008, Vol. 3, Page 3316 given under non absorbable surgical suture.
QUANTITY REQUIRED FOR ANALYSIS
30 + 30 Numbers.
SHELF LIFE
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : S27011
Quality Control Department
Drug Name : Quadraple Bag with SAGM Platelet storage Page 167 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007 & KMSCL In-house Method.
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
316
TESTS AS PER OFFICIAL MONOGRAPH
For CPD as per IP 2007, Volume II, Page 737 – 738: 1. Description 2. Identification : 3. Test 4. PH : 5.0 – 6.0 5. Bacterial Endotoxins : Not more than 5.56 EU/ml Ref G – INJ 006 6. Sterility: Ref. G-INJ 005 7. Particulate matter : G – INJ 001 8. Extractable volume : G – INJ 004 9. Assay: Contains not less than 95.0% and not more than 1050% of the stated amounts of
sodium citrate, citric acid, Sodium Dihydrogen. For SAGM - KMSCL In-house Method:. 1. Description 2. Identification 3. PH : 4.7 – 5.7 FOR SAGM – 1 ; 5 – 6 FOR SAGM – 2 4. Bacterial Endotoxins : Should be less than 5.56 EU/ML REF G-INJ 006 5. Sterility: Ref. G-INJ 005 6. Particulate matter : G – INJ 001 7. Extractable volume : G – INJ 004 8. Assay : 90.0 – 110.0 % of sodium chloride, Adenine, Dextrose (monohydrate) and Mannitol Copy Print HIS of label claim SAGM Page – 1, 2, 3.
LIMITS Indian Pharmacopoeia 2007 & KMSCL In-house Method. LABELLING
1. It contains no antimicrobial agent 2. The composition and volume of the solution 3. Volume of solution required for 100 ,l; of whole blood 4. Where applicable, the maximum amount of blood to be collected in the container.
QUANTITY REQUIRED FOR ANALYSIS-50 numbers
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : S27076 to
S27079 Quality Control Department
Drug Name : Ryle’s Tube Page 1 of 1
Synonym : Copy No. 1
Official Standards : KMSCL In-house Specifications
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
317
TESTS AS PER OFFICIAL MONOGRAPH
1. Description Physical Tests: 2. Number of lateral eyes – Four 3. Marking Ist 50 ± 0.50cm
IInd 60 ± 0.50cm IIIrd 70 ± 0.50cm from distal end
4. Component Physico – Chemical Tests: 5. Non volatile matters NMT 15 mg 6. Reside on ignition NMT 05 mg 7. Radio Opaque line 8. Heavy metals NMT 1.0 PPM 9. Buffering Capacity NMT 10ml of 0.01N HCl Biological Tests: 10. Sterility
ADDITIONAL TESTS Nil.
LIMITS
For test 1 to 10, limit as per KMSCL In-house Specifications.
LABELLING Nil
QUANTITY REQUIRED FOR ANALYSIS 100 Numbers.
SHELF LIFE
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : S27201
Quality Control Department
Drug Name : SICS Blade (Sharp Edge) Crescent Blade 2.8mm Page 1 of 1
Synonym : Copy No. 1
Official Standards : KMSCL In-house Specifications
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
318
TESTS AS PER OFFICIAL MONOGRAPH
Physico Chemical Testing:
1. Surface Finish
2. Corrosion Test
3. Limits for acidity and alkalinity as per ISO - 9626: 2001.
Biological Testing:
4. Sterility
5. Pyrogen Test / BET
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 5, limit as per KMSCL In-house Specifications.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : S27200
Quality Control Department
Drug Name : SICS Blade (Sharp Edge) Keratomo Blade (2.8mm) Page 1 of 1
Synonym : Copy No. 1
Official Standards : KMSCL In-house Specifications
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
319
TESTS AS PER OFFICIAL MONOGRAPH
Physico Chemical Testing:
1. Surface Finish
2. Corrosion Test
3. Limits for acidity and alkalinity Limits as per ISO - 9626 : 2001
Biological Testing:
4. Sterility
5. Pyrogen Test / BET
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 5, limit as per KMSCL In-house Specifications.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : S27202
Quality Control Department
Drug Name : Sics Blade (Sharp Edge) side port Page 1 of 1
Synonym : Copy No. 1
Official Standards : KMSCL In-house Specifications
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
320
TESTS AS PER OFFICIAL MONOGRAPH
Physico Chemical Testing:
1. Surface Finish
2. Corrosion Test
3. Limits for acidity and alkalinity as per ISO - 9626 : 2001.
Biological Testing:
4. Sterility
5. Pyrogen Test / BET
ADDITIONAL TESTS Nil.
LIMITS
For test 1 to 5, limit as per KMSCL In-house Specifications.
STORAGE
Nil
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : S27089 to
S27093 Quality Control Department
Drug Name : Suction Catheter Size – 10 / 12 / 14 / 6 / 8 Page 1 of 1
Synonym : Copy No. 1
Official Standards : KMSCL In-house Specifications
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
321
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Tip 3. Eye 4. Total Length ± 10mm 5. Effective Length 6. O.D ± 15mm 7. Component Fitting 8. Marking 9. Radio Opaque line 10. Colour 11. Leakage Test 12. Chemical Test 13. Sterility 14. Strength of Joint
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 14, limit as per KMSCL In-house Specifications.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
100 Numbers.
SHELF LIFE
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : S27142 to
S27149 Quality Control Department
Drug Name : Surgical Silk 2-0 St. RB 50 mm Needle 76cm Page 1 of 1
Synonym : Copy No. 1
Official Standards : US Pharmacopeia 2008, Volume 3, Page No. 3314-3317
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
322
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Length: Limit – Not less than 95.0 percent of the length stated in the label. 3. Diameter : Limit – Ref. SUT Table 4 4. Tensile strength : Ref. SUT Table 4 5. Needle attachment : Ref. SUT Table 5 & 6 6. Sterility : (If claimed sterile) 7. Extractable colour : Limit - Ref. SUT Table 3 8. Soluble chromium compound: Limit – Colour extracted should be less
intense than the colour of the standard solution.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 8, limit as per USP-2008.
LABELLING
As per USP 2008, Vol. 3, Page 3316 given under non absorbable surgical suture.
QUANTITY REQUIRED FOR ANALYSIS
30 + 30 Numbers.
SHELF LIFE
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : S27150 to
S27154 Quality Control Department
Drug Name : Suture Pack Silk No. 1 Page 1 of 1
Synonym : Copy No. 1
Official Standards :
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
323
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Length: Limit - not less than 95.0% of the length stated on the label. 3. Diameter : Limit – Ref. Table 4 4. Tensile Strength : Ref. Table 4 5. Sterility (If claimed sterile) 6. Needle attachment : Ref. SUT Table 5 6 7. Soluble chromium compounds 8. Extractable colour : Ref. SUT Table 3
ADDITIONAL TESTS
Nil.
LIMITS
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
SHELF LIFE
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : S27165
Quality Control Department
Drug Name : Virgin Silk 8/0 3/8 Circle micropoint spatulated 6mm needle Page 1 of 1
Synonym : Copy No. 1
Official Standards : US Pharmacopeia 2008, Volume 3, Page No. 3314-3317
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
324
TESTS AS PER OFFICIAL MONOGRAPH
9. Description. 10. Length: Limit not less than 95.0% of the length stated on the label. 11. Diameter : Ref. SUT Table II 12. Tensile Strength : Ref. SUT Table II 13. Needle attachment : Ref. SUT Table V & VI 14. Sterility : If sterile 15. Extractable colour (If dyed) : Ref. SUT Table III 16. Soluble Chromium Compounds: Limit colour extracted should be loss
intense than the colour of the standard solution.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 8, limit as per USP-2008.
LABELLING
As per USP 2008, Volume 3, Page 3316, given under non absorbable surgical suture.
QUANTITY REQUIRED FOR ANALYSIS
30 + 30 Numbers.
SHELF LIFE
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : S27166
Quality Control Department
Drug Name : Virgin Silk 8/0 3/8 Circle micropoint spatulated double needle 6mm Page 1 of 1
Synonym : Copy No. 1
Official Standards : US Pharmacopeia 2008, Volume 3, Page No. 3314-3317
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
325
TESTS AS PER OFFICIAL MONOGRAPH
17. Description. 18. Length: Limit not less than 95.0% of the length stated on the label. 19. Diameter : Ref. SUT Table II 20. Tensile Strength : Ref. SUT Table II 21. Needle attachment : Ref. SUT Table V & VI 22. Sterility : If sterile 23. Extractable colour (If dyed) : Ref. SUT Table III 24. Soluble Chromium Compounds: Limit colour extracted should be loss
intense than the colour of the standard solution.
ADDITIONAL TESTS
Nil.
LIMITS
For test 1 to 8, limit as per USP-2008.
LABELLING
As per USP 2008, Volume 3, Page 3316, given under non absorbable surgical suture.
QUANTITY REQUIRED FOR ANALYSIS
30 + 30 Numbers.
SHELF LIFE
326
KKEE
RRAA
LLAA
MM
EEDD
II CCAA
LL
SSEE
RRVV
II CCEE
SS
CCOO
RRPP
OORR
AATT
II OONN
LL
TTDD
MMIISSCCEELLLLAANNEEOOUUSS
QQuuaalliittyy CCoonnttrrooll MMaannuuaall FFoorr
DDrruuggss AAnndd SSuupppplliieess
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D06002
Quality Control Department
Drug Name : Activated Charcoal Powder IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 2, Page No. 895-896
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
327
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Acidity or Alkalinity. 4. Acid soluble substances. 5. Ethanol soluble substances. 6. Alkali soluble coloured matter. 7. Chlorides. 8. Sulphates. 9. Sulphide. 10. Uncarbonised constituents. 11. Copper. 12. Lead. 13. Zinc. 14. Sulphated ash- Not more than 5.0% 15. Loss on drying- NMT 15.0% determined on 1.0 gram in an oven at 105 °C. 16. Adsorbing power.
ADDITIONAL TESTS Nil
LIMITS
For test 1 to 16, limit as per IP-2007.
LABELLING
QUANTITY REQUIRED FOR ANALYSIS
50 Numbers. SHELF LIFE Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D25012
Quality Control Department
Drug Name : Black Disinfectant Fluid Grade-III Page 1 of 1
Synonym : Copy No. 1
Official Standards : IS 1061:1997
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
328
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Stability after dilution 3. Germicidal value- Minimum 5.0 4. Mercury compounds-Should be absent. 5. Rideal Walker Co-efficient using Salmonella typhi - Should pass the test for
normal type.
ADDITIONAL TESTS
LIMITS
For test 1 to 5, limit as per IS 1061:1997.
LABELLING
QUANTITY REQUIRED FOR ANALYSIS
20 Numbers.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D25011
Quality Control Department
Drug Name : Bleaching Powder 30 % IP Page 1 of 1
Synonym : Chlorinated Lime Copy No. 1
Official Standards : Indian Pharmacopoeia 1985, Appendix A-172
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
329
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Identification 3. Solubility-Slightly soluble in water. 4. Stability-Loses NMT 3.0 % of its available chlorine by weight when heated
to 100°C for 1 hour. 5. Assay: - Limit NLT 30.0%w/w of available chlorine.
ADDITIONAL TESTS
Nil
LIMITS
For test 1 to 5, limit as per IP-1985, Appendix A-172.
LABELLING
QUANTITY REQUIRED FOR ANALYSIS
40 Numbers.
SHELF LIFE
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D14017
Quality Control Department
Drug Name : Gentian Violet Paint BPC Page 1 of 1
Synonym : Crystal Violet Paint Copy No. 1
Official Standards : British Pharmaceutical Codex 1973
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
330
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Light absorption (NLT 0.32 at 585 nm).
ADDITIONAL TESTS
Nil
LIMITS
For test 1 to 2, limit as per BPC-1973
LABELLING
QUANTITY REQUIRED FOR ANALYSIS
2 x 500 ml.
SHELF LIFE
Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D14003
Quality Control Department
Drug Name : Liquid Paraffin IP Page 1 of 1
Synonym : White Mineral Oil, Liquid Petroleum Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 3, Page No. 1517-1518
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
331
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Weight per ml-Limit-0.866 to 0.904 gram 3. Dynamic Viscosity-Limit, 110 m Pas to 230 m Pas determined
at 20°c± 1° C by method B 4. Acidity or Alkalinity 5. Light absorption 6. Readily carbonisable substances 7. Solid Paraffin’s 8. Sulphur compounds
ADDITIONAL TESTS
Nil
LIMITS
For test 1 to 8, limit as per IP-2007.
LABELLING
QUANTITY REQUIRED FOR ANALYSIS
2 Numbers.
SHELF LIFE
Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D04015
Quality Control Department
Drug Name : Nitrous Oxide IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 3, Page No. 1450
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
332
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Acidity or alkalinity. 4. Arsine and phosphine. 5. Carbon dioxide. 6. Carbon monoxide. 7. Halogens and hydrogen sulphide. 8. Nitric oxide and nitrogen dioxide. 9. Oxidising substances. 10. Water. 11. Assay- not less than 98.0 % v/v of Nitrous oxide.
ADDITIONAL TESTS Nil
LIMITS
For test 1 to 11, limit as per IP-2007.
LABELLING
The cylinder is printed blue and carries a label stating “NITROUS OXIDE”. In addition “NITROUS OXIDE” or the symbol “N2O”, should be Stenciled in paint on the shoulder of the cylinder.
QUANTITY REQUIRED FOR ANALYSIS
1 Number.
SHELF LIFE
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D04016
Quality Control Department
Drug Name : Oxygen IP Page 1 of 1
Synonym : Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 3, Page No. 1486
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
333
TESTS AS PER OFFICIAL MONOGRAPH
1. Description. 2. Identification. 3. Carbon dioxide. 4. Carbon monoxide. 5. Water vapour. 6. Assay- not less than 99.0 % v/v of Oxygen.
ADDITIONAL TESTS
Nil
LIMITS
For test 1 to 6, limit as per IP-2007.
LABELLING
The shoulder of the metal cylinder should be painted white and the remainder should be painted black. The cylinder should carry a label stating “oxygen”, in addition “OXYGEN” or the Symbol “O2” should be stenciled in paint on the shoulder of the cylinder.
QUANTITY REQUIRED FOR ANALYSIS
1 Number.
SHELF LIFE
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D14016
Quality Control Department
Drug Name : Purified Talc IP Page 1 of 1
Synonym : Talc, Talcum Copy No. 1
Official Standards : Indian Pharmacopoeia 2007, Volume 3, Page No. 1779
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
334
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Identification 3. Acidity or Alkalinity 4. Iron 5. Acid soluble substances 6. Water soluble substances 7. Carbonates 8. Chlorides 9. Organic Compounds 10. Loss on Drying-NMT 1.0% (180°C for 1 hour)
ADDITIONAL TESTS Nil
LIMITS
For test 1 to 10, limit as per IP-2007.
LABELLING
QUANTITY REQUIRED FOR ANALYSIS
2 Numbers.
SHELF LIFE
Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D25002
Quality Control Department
Drug Name : Surgical Spirit 70.0%v/v BP Page 1 of 1
Synonym : Copy No. 1
Official Standards : British Pharmacopoeia 2009, Volume 3, Page No. 2994
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
335
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Identification 3. Weight/ml-Limit 0.817 to 0.827 4. Assay: -
For methyl salicylate-limit- 0.45%v/v to 0.55% v/v For diethylphthalate-limit- 1.80% v/v to 2.20% v/v
ADDITIONAL TESTS
Nil
LIMITS
For test 1 to 4, limit as per BP-2009.
LABELLING
1. The label states that the preparation is flammable and should be kept away from naked eye.
2. The date after which the spirit is not intended to be used. 3. The condition under which the spirit should be stored. (Refer page 2254
BP)
QUANTITY REQUIRED FOR ANALYSIS
4 Numbers.
SHELF LIFE
Minimum 18 months.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D25013
Quality Control Department
Drug Name : Washing Soda Page 1 of 1
Synonym : Copy No. 1
Official Standards : IS 251:1998, IS 251:1972
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
336
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Bulk density: 3. Dense grade 950 to 1256 g/l. 4. Light grade 500 to 750 g/l. 5. Volatile matter content: not exceeding 2%. 6. Total alkalinity (as Na2CO3): not less than 98.5% on dry basis. 7. Matter insoluble in water: not less than 0.15%w/w. 8. Sulphates (as na2so4): not more than 0.08%w/w. 9. Chlorides (as NaCl): not more than 1%w/w. 10. Iron (as Fe2O3): not more tan 0.007%w/w.
ADDITIONAL TESTS Nil
LIMITS
For test 1 to 10, limit as per IS 251:1998 and IS 251:1972.
LABELLING
Packages may be marked with ISI certification. Should mention as, for washing/ cleaning use only.
QUANTITY REQUIRED FOR ANALYSIS
2 Numbers.
SHELF LIFE Minimum 2 years.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Drug Code : D14015
Quality Control Department
Drug Name : White Soft Paraffin IP Page 1 of 1
Synonym : White Petroleum Jelly Copy No.
1
Official Standards : Indian Pharmacopoeia 2007, Volume 3, Page No. 1518
Prepared By:
Date:
Name:
(Asst. Manager - QC)
Checked By:
Date:
Name:
(Head - QC)
Approved By:
Date:
Name:
(Head - QA)
Authorized By:
Date:
Name:
(Managing Director)
337
TESTS AS PER OFFICIAL MONOGRAPH
1. Description 2. Melting range –Limit-38°c to 56°c. 3. Acidity or Alkalinity 4. Light absorption-NMT 0.5 5. Fixed oils ,fats and resins 6. Foreign organic matter 7. Constitency 8. Sulphated Ash-Limit NMT 0.1%
ADDITIONAL TESTS
Nil
LIMITS
For test 1 to 8, limit as per IP-2007.
LABELLING
Nil
QUANTITY REQUIRED FOR ANALYSIS
2 Numbers.
SHELF LIFE
Minimum 2 years.
338
KKEE
RRAA
LLAA
MM
EEDD
II CCAA
LL
SSEE
RRVV
II CCEE
SS
CCOO
RRPP
OORR
AATT
II OONN
LL
TTDD
GGEENNEERRAALL TTEESSTTSS
QQuuaalliittyy CCoonnttrrooll MMaannuuaall FFoorr
DDrruuggss AAnndd SSuupppplliieess
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND MEDICINES Quality Control Department
GENERAL TESTS - TABLETS
339
≥25mg &≥25% <25mg or <25%
Uncoated WV CUFilm WV CU
Others CU CUHard WV CU
Suspension, emulsion or
gelCU CU
Solutions WV WVSingle
componentWV WV
Solution freeze-dried
in final container
WV WV
Others CU CU
CU CU
WV WV
CU CU
CU CUCU CUCU CUOthers
TabletsCoated
CapsulesSoft
Solids in single unit containersMultiple
component
Suspension, emulsion, or gel for systemic use only, packaged in single-unit containers
Solutions for inhalation packaged in glass or plastic ampuls and intended for use in nebulizers, and oral solutions packaged in unit-dose containsers and into soft capsules
Inhalations (other than solutions for inhalation packaged in glass or plastic ampulos and intended for use in nebulizers) packaged in premetered dosage units.
Transdermal systemsSuppositories
Table 1. Application of Content Uniformity (CU) and Weight Variation (WV) Tests for Dosage Forms
Dose & ratio of Drug Type SubtypeDosage Form
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND MEDICINES Quality Control Department
GENERAL TESTS - TABLETS
340
G-TAB- 001 Uniformity of content :
This test is applicable to tablets that contain 10mg or less than 10mg or less than 10% w/w of active ingredient. For tablets containing more than 1 active ingredient carry out the test for each active ingredient that corresponds to the aforementioned conditions. The test is also applicable to coated tablets other than film coated tablets, irrespective of their content of active substances. Determine the content of active ingredient(s) in each 10 tablets taken at random using the method given in the monograph or by any other suitable analytical method. The preparation complies with the test, if each individual content is 85.0 to 115.0 % of the average content. The preparation fails to comply with the test if more than 1individual content is outside these limits or if 1individual content is outside the limits of 75.0 to 125.0% of the average content.
If 1individual content is outside the limits of 85.0 to 115 .0% of the average content, but with in the limits of 75.0 to 125.0%, repeat the determination using another 20 tablets. The preparation complies with the test if not more than 1 of the individual contents of the total sample of 30 tablets is outside the limits of 85.0 to 115.0 % of average content and none is outside the limits of 75.0 to 125.0% of the average content.
G-TAB -002 Uniformity of weight:
Not applicable to coated tables other than film coated tablets and to tablets that are required to comply with the test for uniformity of content for all active ingredients.
Weigh individually 20 units selected at random and calculate the average weight.
Not more than 2 of the individual weights deviates from the average weight by more than the per cent shown in the table and none deviates by more than twice that percentage.
Average Weight (uncoated & film coated tablets) Percentage deviation
80mg or less 10
More than 80 mg but less than 250mg 7.5
250mg or more 5
G-TAB- 003 Dissolution:
Where required the requirements for this test are given in the individual monograph.
Level Number tested Acceptance Criteria
S1 6 Each unit is not less than D* + 5 % **
S2 6 Average of 12 units (S1+S2) is equal to or greater than D, and no unit is less than D-15 % **
S3 12 Average of 24 units (S1+S2+S3) is equal to or greater than D, not, More than 2 units are less than D-15%** and no unit is less than D-25 %**
*D is the amount of dissolved active ingredient specified in the individual monograph, expressed as a percentage of the labelled content.
** Percentage of the labelled content.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND MEDICINES Quality Control Department
GENERAL TESTS - TABLETS
341
G-TAB- 004 Disintegration:
(Not necessary if dissolution test is prescribed):
Formulation Limit
Uncoated tablets 15 minutes( with disc, in water at 37 ± 20 C
Coated tablets other than film coated 60 minutes( with disc, in water at 37 ± 20, if fails repeat with another 6 tablets in 0.1 M Hcl at 37 ± 20C
Film Coated tablets 30 minutes (with disc, in water at 37 ±20C)
Dispersible tablets 3 minutes (with disc, in water 240-260 C )
Effervescent Tablets 5 minutes (see page No. 664 of IP 2007 , Vol 2)
Soluble Tablets 3 minutes ( with disc, in water at 15 C – 25 C )
Enteric Coated tablets If the tablet has a soluble external coating, immerse the basket in water at room at temperature for 5 minutes. Suspend the assembly in the beaker containing 0.1 M hydrochloric acid and operate without the disc for 120 minutes, unless otherwise stated in the individual monograph. Remove the assembly from the liquid. No tablet shows signs of cracks that would allow the escape of the contents of disintegration, apart from fragments of coating. Replace the liquid in the beaker with mixed phosphate buffer PH 6.8, add a disc, to each tube and operate the apparatus for a further 60 minutes. Remove the assembly from the liquid. The tablets pass the test if all six have disintegrated.
G-TAB- 005 Uniformity of Dispersion :
(only for dispersible tablets ):
Place 2 tablets in 100ml of water and stir gently until completely dispersed. A smooth dispersion is obtained which passes through a sieve screen with a nominal mesh aperture of 710 mm (sieve number 22)
ADDITIONAL TESTS
G-TAB-006 Hardness:
Minimum 3 Kg / cm2
G-TAB-007 Friability: (only for uncoated tablets )
A maximum loss of weight not greater than 1% is acceptable for most tablets If obviously cracked , chipped or broken tablets are present in the sample after tumbling the sample fails the test. (Reference Page 183 of IP 2007 Vol. 1
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND MEDICINES Quality Control Department
GENERAL TESTS - TABLETS
342
G-CAP-001 Uniformity of weight:
(The test is not required if the test uniformity of content is prescribed )
If average weight of capsule contents;
a) less than300 mg, deviation allowed is 10% b) 300 mg or more, deviation allowed is 7.5%.
G-CAP-002 Uniformity of Content:
This test is applicable to capsules that contain less than 10mg or less than 10% w/w of active ingredient. For capsules containing more than 1 active ingredient carry out the test for each active ingredient that corresponds to the aforementioned conditions.
Determine the content of active ingredient in each of 10 capsules taken at random using the method given in the monograph or by any other suitable analytical method of equivalent accuracy and precession. The capsules comply with the test if not more than 1 of the individual values thus obtained is outside the limits 85 to 115 % of the average value and none is outside the limits 75 to 125% . If 2 or 3 individual values are outside the limits 85 to 115% of the average values repeat the determination using another 20 capsules. The capsules comply with the test if in the total sample of 30 capsules not more than 3 individual values are outside the limits 85 to 115% and none is outside the limits 75 to 125% of the average value.
The test is not applicable for capsules containing multivitamins and trace elements.
G-CAP- 003 Disintegration:
(This test is not required for the capsules for which dissolution test is included in the individual monograph)
a) Hard Gelatin capsules--30 minutes b) Soft Gelatin capsules--60 minutes c) Enteric coated capsules—2 Hours in 0.1 M Hcl. without discs. No capsule shows signs of disintegration or
of rapture permitting the escape of the contents . Replace the medium in the vessel with mixed phosphate buffer PH 6.8 Add a disc to each tube and operate the apparatus for a further 60 minutes . They pass the test if no residue remains on the screen or on the underside of the discs, or, if a residue remains , it consists of fragments of shell or of a soft mass with no palpable , unmoistened core.
G-CAP- 004 Dissolution:
LEVEL Number tested Acceptance criteria
S-1 6 Each unit is not less than D *+ 5 Per cent **
S-2 6 Average of 12 units (S1+S2)is equal to or greater than D, and no unit is less than D-15.0 % **
S-3 12 Average of 24 units(S1+S2+S3) is equal to or greater than D, not more than 2 units are less than D-15 % **and no unit is less than D-25.0 %**
*D is the amount of dissolved active ingredient specified in the individual monograph, expressed as a percentage of the labelled content.
**Percentages of the labelled content
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND MEDICINES Quality Control Department
GENERAL TESTS - ORAL LIQUIDS
343
(Elixirs, Linctuses, Mixtures, Oral drops, Syrups, Orals emulsions,
Oral Solutions, Oral Suspensions)
G-ORA-001 Uniformity of content:
Unless otherwise specified, single dose liquids in suspension form or powders or granules presented in single dose containers and that contain less than 10mg or less than 10% of active ingredient comply with the following test. For oral liquids containing more than 1 active ingredient, carry out the test for each active ingredient that corresponds to the above conditions. Determine the contents of active ingredient(s) of each 10 containers taken at random using the method given in the monograph or by any other suitable analytical method of equivalent accuracy and precision. The preparation complies with the test if the individual values thus obtained are all between 85 to 115 % of average value. The preparation fails to comply with the test if more than 1 individual value is outside the limits 85 to 115% of average value or if anyone individual value is outside the limits 75 to 125% of the average value. If one individual value is outside the limits 85 to 115 % but within the limits 75 to 125% of the average value, repeat the determination using another 20 containers taken at random. The preparation complies with the test if in the total sample of 30 containers not more than 3 individual values are outside the limits 85 to 115 % and not more than one is outside the limits 75 to 125% of the average value.
G-ORA-002 Uniformity of volume:
The average net volume of the contents of the 10 containers is not less than the labelled amount , and the net volume of the contents of any single containers is not less than 91 per cent and not more than 109 per cent of the labelled amount where the labelled amount is 50 ml or less, or not less than 95.5 per cent and not more than 104.5 per cent of the labelled amount where the labelled amount is more than 50 ml but not more than 200 ml, or not less than 97 per cent but not more than 103 per cent of the labelled amount where the labelled amount is more than 200ml but not more than 300 ml.
If this requirement is not met, determine the net volume of the contents of 10 additional containers. The average net volume of the contents of the 20 containers is not less than the labelled amount, and the net volume of the contents of not more than 1 of the 20 containers is less than 91 per cent or more than 109 per cent of the labelled amount where the labelled amount is 50 ml or less or less than 95.5 per cent or more than 104.5 per cent of the labelled amount where the labelled amount is more than 50 ml but not more than 200 ml, or less than 97 per cent or more than 103 per cent of the labelled amount where the labelled amount is more than 200ml but not more than 300 ml.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND MEDICINES Quality Control Department
GENERAL TESTS - ORAL POWDERS
344
G-ORP-001 Uniformity of content:
Unless otherwise specified, Oral powders presented in single dose containers that contain less than 10 mg of active ingredient per dose or that contain less than 10 % w/w of active ingredient comply with the following test. For oral powders containing more than 1 active ingredient carry out the test for each active ingredient that corresponds to the above conditions. Determine the content of active ingredient(s) of each 10 containers taken at random using the method given in the monograph or by any other suitable analytical method of equivalent accuracy and precision. The preparation complies with the test if the individual values thus obtained are all between 85 to 115 % of average value. The preparation fails to comply with the test if more than 1 individual value is outside the limits 85 to 115% of average value or if anyone individual value is outside the limits 75 to 125% of average value. If one individual value is outside the limits 85 to 115 % but within the limits 75 to 125% of the average value, repeat the determination using another 20 containers taken at random. The preparation complies with the test if in the total sample of 30 containers not more than 3 individual values are outside the limits 85 to 115 % and not more than one is outside the limits 75 to 125% of the average value.
Note: Test for Uniformity of content is not applicable to preparations containing multivitamins and trace elements.
G-ORP-002 Uniformity of Weight:
The average net weight of the contents of the 10 containers is not less than the labelled amount and the net weight of the contents of any single containers is not less than 91 % and not more than 109 % of the labelled amount where the labelled amount is 50gm or less, or not less than 95.5% and not more than 104.5% of the labelled amount where the labelled is more than 50gm but not more than 100gm.
If this requirement is not met determine the net weight of the contents of 10 of additional containers. The average net weight of the contents of the 20 containers is not less than the labelled amount, and the net weight of the contents of not more than 1 of the 20 containers is less than 91% or more than 109% of the labelled amount where the labelled amount is 50gm, or less than 95.5% or more than 104.5% of the labelled amount is more than 50gm but not more than 100gm.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND MEDICINES Quality Control Department
GENERAL TESTS - GELS
345
G-GEL-001 Uniformity of weight:
The average net weight of the contents of the 10 containers is not less than the labelled amount and the net weight of the contents of any single container is not less than 91 % and not more than 109 % of the labelled amount where the labelled amount is 50gm or less, or not less than 95.5% and not more than 104.5% of the labelled amount where the labelled is more 50gm but not more than 100gm.
If this requirement is not met determine the net weight of the contents of 10 of additional containers. The average net weight of the contents of the 20 containers is not less than the labelled amount, and the net weight of the contents of not more than 1 of the 20 containers is less than 91% or more than 109% of the labelled amount where the labelled amount is 50gm or less than 95.5% or more than 104.5% of the labelled amount is more than 50gm but not more than 100gm.
G-GEL -002 Sterility: (if labelled as sterile)
Should comply with the test for sterility as per IP 2007.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND MEDICINES Quality Control Department
GENERAL TESTS - CREAMS
346
G-CRE-001 Uniformity of weight:
The average net weight of the contents of the 10 containers is not less than the labelled amount and the net weight of the contents of any single container is not less than 91 % and not more than 109 % of the labelled amount where the labelled amount is 50gm or less, or not less than 95.5% and not more than 104.5% of the labelled amount where the labelled amount is more than 50gm but not more than 100gm.
If this requirement is not met determine the net weight of the contents of 10 additional containers . The average net weight of the contents of the 20 containers is not less than the labelled amount, and the net weight of the contents of not more than 1 of the 20 containers is less than 91% or more than 109% of the labelled amount where the labelled amount is 50gm or less, 95.5% or more than 104.5% of the labelled amount where the labelled amount 50gm but not more than 100gm.
G-CRE -002 Sterility: (if labelled as sterile)
Should comply with the Test for Sterility as per IP 2007.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND MEDICINES Quality Control Department
GENERAL TESTS - OINTMENTS
347
G-OIN-001 Uniformity of weight:
The average net weight of the contents of the 10 containers is not less than the labelled amount and the net weight of the contents of any single containers is not less than 91 % and not more than 109 % of the labelled amount where the labelled amount is 50gm or less, or not less than 95.5% and not more than 104.5% of the labelled amount where the labelled is more 50gm but not more than 100gm.
If this requirement is not met determine the net weight of the contents of 10 of additional containers. The average net weight of the contents of the 20 containers is not less than the labelled amount, and the net weight of the contents of not more than 1 of the 20 containers is less than 91% or more than 109% of the labelled amount where the labelled amount is 50gm or less than 95.5% or more than 104.5% of the labelled amount is more than 50gm but not more than 100gm.
G-OIN -002 Sterility: (if labelled as sterile)
Should comply with the Test for Sterility as per IP 2007.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND MEDICINES Quality Control Department
GENERAL TESTS - PESSARIES
348
1. COMPRESSED PESSARIES – (VAGINAL TABLET) 2. SHELL PESSARIES - (VAGINAL SOFT CAPSULES) 3. MOULDED PESSARIES
G-PES-001 Uniformity of Content:
This test is applicable to Pessaries that contain less than 10mg or less than 10% of active ingredient. For pesssaries containing more than 1 active ingredient carry out the test for each active ingredient that corresponds to the above conditions. Determine the content of active ingredient in each of 10 pessaries taken at random using the method given in the monograph or by any other suitable analytical method of equivalent accuracy and precision. The preparation complies with the test, if not more than 1of the individual content thus obtained is outside the limits 85.0 to 115.0 % of the average content and none is outside the limits 75.0 to 125 % of the average content.
If 2 or 3 individual contents are outside the limits of 85.0 to 115 .0% of the average content, repeat the determination using another 20 dosage units. The preparation complies with the test if in the total sample of 30 pessaries not more than 3 individual contents are outside the limits 85.0 to 115.0 % and none is outside the limits 75.0 to 125.0% of the average content.
G-PES-002 Uniformity of Weight:
This test is not applicable to pessaries that are required to comply with the test for uniformity of content for all active ingredients .Weigh individually 20 Pessaries, taken at random, and determine the average weight. Not more than two of the individual weights deviate from the average weight by more than 5 per cent and none deviates by more than 10 per cent.
G-PES-003 Disintegration:
Not more than 30 minutes for compressed pessaries and shell pessaries. Not more than 60 minutes for moulded pessaries. The test is not necessarily applicable to pessaries intended for modified release or for prolonged local action.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND MEDICINES Quality Control Department
GENERAL TESTS - SUPPOSITORIES
349
1. MOULDED SUPPOSITORIES 2. SHELL SUPPOSITORES (RECTAL CAPSULES )
G-SUP-001 Uniformity of Content:
This test is applicable to Suppositories that contain less than 10mg or less than 10% of active ingredient. For Suppositories containing more than 1 active ingredient carry out the test for each active ingredient that corresponds to the above conditions. Determine the content of active ingredient in each of 10 suppositories taken at random using the method given in the monograph or by any other suitable analytical method of equivalent accuracy and precision. The preparation complies with the test, if not more than 1of the individual content thus obtained is outside the limits 85.0 to 115.0 % of the average content and none is outside the limits 75.0 to 125 % of the average content.
If 2 or 3 individual contents are outside the limits of 85.0 to 115 .0% of the average content, repeat the determination using another 20 dosage units. The preparation complies with the test if in the total sample of 30 suppositories not more than 3 individual contents are outside the limits 85.0 to 115.0 % and none is outside the limits 75.0 to 125.0% of the average content
G-SUP-002 Uniformity of Weight:
This test is not applicable to Suppositories that are required to comply with the test for uniformity of content for on active ingredients .Weigh individually 20 Suppositories, taken at random, and determine the average weight. Not more than two of the individual weights deviate from the average weight by more than 5 per cent and none deviates by more than 10 percent.
G-SUP-003 Disintegration:
Not more than 30 minutes for shell suppositories. Not more than 60 minutes for moulded suppositories
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND MEDICINES Quality Control Department
GENERAL TESTS - EYE / EAR DROPS
350
G-EAR-001 Uniformity of Volume:
The average net volume of the contents of 10 containers is not less than the labelled amount and a net volume of contents of any single container is not less than 91% and not more than 109% of the labelled amount.
G-EAR-002 Particle Size:
(Test is applicable to ear drops and eye drops that are suspensions)
Not more than 20 particles have a maximum dimension greater than 25 µm and not more than 10 particles have a maximum dimension greater than 50 µm and none has maximum dimension greater than 100 µm .
G-EAR-003 Sterility:
(Where the label indicates the ear drops / eye drops are sterile)
Should comply with the test for sterility as per IP2007. Droppers supplied separately also should comply with sterility test
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND MEDICINES Quality Control Department
GENERAL TESTS - EYE OINTMENTS
351
G-EYO-001 Uniformity of Weight:
The average net weight of the contents of the 10 containers is not less than the labelled amount and the net weight of the contents of any single container is not less than 91 % and not more than 109 % of the labelled amount where the labelled amount is 50gm or less.
.
If this requirement is not met determine the net weight of the contents of 10 of additional containers. The average net weight of the contents of the 20 containers is not less than the labelled amount, and the net weight of the contents of not more than 1 of the 20 containers is less than 91% or more than 109% of the labelled amount where the labelled amount is 50gm or less.
G-EYO-002 Particle Size:
(Test is applicable to ear drops and eye drops that are suspensions)
Not more than 20 particles have a maximum dimension greater than 25 µm and not more than 10 particles have a maximum dimension greater than 50 µm and none has a maximum dimension greater than 100 µm .
G-EYO-003 Sterility:
(Where the label indicates the ear drops / eye drops are sterile)
Should comply with the test for sterility as per IP2007.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND MEDICINES Quality Control Department
GENERAL TESTS - NASAL PREPARATIONS
352
G-NAS-001 Uniformity of Content:
Unless otherwise specified in individual monograph nasal preparation that are presented in single dose containers and that contain less than 10 mg or less than 10 % of active ingredient comply with the following test. For nasal preparations containing more than 1 active ingredient carry out the test for each active ingredient that corresponds to the above conditions. Determine the content of active ingredient(s) of each 10 containers taken at random using the method given in the monograph or by any other suitable analytical method of equivalent accuracy and precision. The preparation complies with the test if the individual values thus obtained are all between 85 and 115 % of average value. The preparation fails to comply with the test if more than 1 individual value is outside the limits 85 to 115% of average value or if any one individual value is outside the limits 75 to 125% of average value. If one individual value is outside the limits 85 to 115 % but within the limits 75 to 125% of the average value, repeat the determination using another 20 containers taken at random. The preparation complies with the test if in the total sample of 30 containers not more than one individual value is outside the limits 85 to 115 % and none is outside the limits 75 to 125% of the average value.
G-NAS-002 Uniformity of Weight / Volume:
Nasal preparation supplied in single application containers comply with this test. The average net weight / net volume of contents of 10 containers is not less than 91% and not more than 109% of the labelled amount where the labelled amount is 50gm / 50ml or less. If the requirement is not met determine the net weight / net volume of 10 additional containers. The average net weight / net volume of 20 containers are not less than the labelled amount and net weight / net volume of not more than 1 of 20 containers is less than 91 % or more than 109% of the labelled amount where the labelled amount is 50gm / 50ml or less).
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND MEDICINES Quality Control Department
GENERAL TESTS - PARENTERAL PREPARATIONS As Per Indian Pharmacopoeia
353
A. INJECTIONS
G-INJ-001 Particulate Matter:
Injections that are solutions, when examined under suitable conditions of visibility, are clear and practically free from particles that can be observed on visual inspection by the unaided eye. For multiple dose injections, single dose small volume parenteral preparations and parenteral solutions constituted from sterile solids the test for visible particles under (2.5.9) particulate contamination in IP 2007 volume 1 page 186 is adequate.
Parenteral Preparations in containers that are labelled as containing 100ml or more of a single dose large volume injection intended for administration by intravenous infusion should comply with the limits of sub visible particles under the test for particulate contamination in IP 2007 volume 1 page 186 -188
G-INJ-002 Particulate Contamination:
Injections that are supplied in containers with a nominal content of 100ml or more comply with the test for particulate contamination.
Method 1
Sample Particle size in µm
(equal to or greater than)
Maximum number of Particles
(Average in the units tested)
Preparation in containers with nominal content of more than 100 ml
10
25
12 per ml
2 per ml
Preparation in containers with nominal content of 100 ml
10
25
3000 per container
300 per container
Less than 100 ml 10
25
3000 per container
300 per container
Method 2
Sample Particle size in µm
(equal to or greater than)
Maximum number of particles
(Average in the units tested)
Preparation in containers with nominal content of more than 100 ml
10
25
25 per ml
3 per ml
Preparation in containers with nominal content of 100 ml
10
25
6000 per container
600 per container
Less than 100 ml 10
25
6000 per container
600 per container
G-INJ-003 Uniformity of Content:
Unless otherwise specified in individual monograph suspensions for injection that are presented in single dose containers and that contain less than 10 mg or less than 10 % of active ingredient comply with the following test.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND MEDICINES Quality Control Department
GENERAL TESTS - PARENTERAL PREPARATIONS As Per Indian Pharmacopoeia
354
For suspensions for injections containing more than 1 active ingredient carry out the test for each active ingredient that corresponds to the above conditions. Determine the content of active ingredient(s) of each of 10 containers taken at random using the method given in the monograph or by any other suitable analytical method of equivalent accuracy and precision. The preparation complies with the test if the individual values thus obtained are all between 85 and 115% of average value. The preparation fails to comply with the test if more than 1 individual value is outside the limits 85 to 115% of average value or if any one individual value is outside the limits 75 to 125% of average value. If one individual value is outside the limits 85 to 115% but within the limits 75 to 125% of the average value, repeat the determination using another 20 containers taken at random. The preparation complies with the test if in the total sample of 30 containers not more than one individual value is outside the limits 85 to 115 % and none is outside the limits 75 to 125% of the average value.
Note: The test for uniformity of content is not applicable to suspensions for injections containing multivitamins and trace elements.
G-INJ-004 Extractable Volume:
Sl. No. Nominal Volume Limits
1. Does not exceed 5 ml Average content of the 5 containers is not less than the nominal volume and not more than 115% of the nominal volume
2. Greater 5 ml The contents of each of the 3 containers are not less than the nominal volume and not more than 110% of the nominal volume
G-INJ-005 Sterility:
Should comply with the test for sterility as per IP 2007.
G-INJ-006 Bacterial Endotoxins / Pyrogen:
As per individual monograph.
B. INFUSIONS
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND MEDICINES Quality Control Department
GENERAL TESTS - PARENTERAL PREPARATIONS As Per Indian Pharmacopoeia
355
G-INF-001 Particulate Contamination:
ntravenous infusions that are solutions, when examined under suitable conditions of visibility are clear and practically free from particles that can be observed on visual inspection by the unaided eye. Intravenous infusions that are solutions and are supplied in containers with a nominal content of 100ml or more comply with the test for particulate contamination.
Method 1
Sample
Particle size in µm
(equal to or greater than)
Maximum number of Particles
(Average in the units tested)
Preparation in containers with nominal content of more than 100 ml
10
25
12 per ml
2 per ml
Preparation in containers with nominal content of 100 ml
10
25
3000 per container
300 per container
Less than 100 ml 10
25
3000 per container
300 per container
Method 2
Sample
Particle size in µm
(equal to or greater than)
Maximum number of particles
(Average in the units tested)
Preparation in containers with nominal content of more than 100 ml
10
25
25 per ml
3 per ml
Preparation in containers with nominal content of 100 ml
10
25
6000 per container
600 per container
Less than 100 ml 10
25
6000 per container
600 per container
G-INF-002 Sterility:
Should comply with the test for sterility as per IP 2007.
G-INF-003 Bacterial Endotoxins / Pyrogen:
As per individual monograph.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND MEDICINES Quality Control Department
GENERAL TESTS - PARENTERAL PREPARATIONS As Per Indian Pharmacopoeia
356
C. POWDERS FOR INJECTION
G-POW-001 Uniformity of Content:
Unless otherwise stated in the individual monograph, Powders for injection that contain 10mg or less than 10mg or less than 10 % of active ingredient or that have a unit weight equal to or less than 50mg comply with the test for Uniformity of content. For Powders for injection containing more than 1 active ingredient carry out the test for each active ingredient that corresponds to the above conditions. This test is not applicable to powders for injection containing multivitamins and trace elements. Determine the content of active ingredient(s) of each of 10 containers taken at random using the method given in the monograph or by any other suitable analytical method of equivalent accuracy and precision. The preparation complies with the test if the individual values thus obtained are all between 85 and 115 % of average value. The preparation fails to comply with the test if more than 1 individual value is outside the limits 85 to 115% of average value or if anyone individual value is outside the limits 75 to 125% of average value. If one individual value is outside the limits 85 to 115 % but within the limits 75 to 125% of the average value, repeat the determination using another 20 containers taken at random. The preparation complies with the test if in the total sample of 30 containers not more than one individual value is outside the limits 85 to 115 % and none is outside the limits 75 to 125% of the average value.
G-POW-002 Uniformity of Weight:
For powders for injection that are required to comply with the test for Uniformity of content of all active ingredients, the test for uniformity of weight is not required.
Out of 20 units tested not more than 2 of the individual weights deviate from the average weight by more than 10 % and none deviates by more than 20%.
G-POW-003 Clarity of Solution:
Constitute the injection as directed on the label.
a) The solid dissolves completely, leaving no visible residue as un dissolved matter
b) The constituted injection is not significantly less clear than an equal volume of the diluents or of water for injections contained in a similar container and examined in the same manner.
G-POW-004 Sterility:
Should comply with the test for sterility as per IP 2007.
G-POW-005 Particulate Matter:
Constitute the injection as directed on the label; the solution is essentially free from particles of foreign matter that can be seen on visual inspection.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND MEDICINES Quality Control Department
GENERAL TESTS - PARENTERAL PREPARATIONS As Per British Pharmacopoeia
357
INJECTIONS BP
I. Particulate contamination; sub-visible particles
TABLE I (A) Light Obscuration particle count test method I
1. Large volume parenterals 1 Unit 2. Small volume parenterals less than
25 ml Contents of 10or more units are combined in a clean container to obtain a volume of not less than 25 ml
3. Small – volume parenterals having a volume of 25 ml or more
Tested Individually NMT than 10 units may be tested.
Remove 4 portions, each of not less than 5 ml, and count the number of particles of 10-25 µm and calculate the mean number of particles.
Table II
Evaluation Sample Particle size Maximum number of particles Preparation in containers with a nominal volume
Equal to greater than
Average number of particles present in the units
More than 100 ml 10 µm 25 per ml 25 µm 3 per ml
Less than 100l 10 µm 6000 per container 25 µm 600 per container
100ml 10 µm 6000 per container 25 µm 600 per container
If the average number of particles exceeds the limit, test the preparation by the microscopic particle count test.
B) Microscopic particle count test method
1. Large volume parenterals 1 Unit 2. Small volume parenterals
less than 25 ml Contents of 10or more units are combined in a clean container to obtain a volume of not less than 25 ml
3. Small – volume parenterals having a volume of 25 ml or more
Tested Individually xxxxxxxxx than 10 units may be tested.
Evaluation
Sample Particle size
Maximum number of particles
Preparation in containers with a nominal volume
Equal to or greater than
Average number of particles present in the units
More than 100 ml 10 µm 12 per ml 25 µm 2 per ml
Less than 100l 10 µm 3000 per container 25 µm 300 per container
100ml 10 µm 3000 per container 25 µm 300 per container
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND MEDICINES Quality Control Department
GENERAL TESTS - PARENTERAL PREPARATIONS As Per British Pharmacopoeia
358
METHOD II
Particle contamination : Visible particlesSelect 5 container and record the presence of any particles by visual
Note: For preparation for human use, solutions for infusions or solutions for injection comply with the test.
Preparations for subcutaneous or intramuscular injections higher limits may be appropriate.
VET: If the content is more than 100 ml comply with the test.
Particulate contamination BP
A. Particulate contamination : Sub-visible particles
Particulate contamination of injections and infusions consists of extraneous, mobile un dissolved particles, other than gas hobbles, unintentionally present in the solutions.
1. Method – I Light obscuration particle count test
2. Method – II Microscopic particle count test
When examining injections and infusions for sub-visible particles, method I is preferably applied. If any conclusion required use Method II.
Not all parenteral preparations can be examined for such visible particles by one or both of these methods.
When method I is not applicable e.g. In case of preparations having reduced clarity or increased viscosity. (Emulsions, colloids and liposomal preparations), Method II.
Products that produce air or gas bubbles when drawn into the sensor require microscopic particle count testing.
If the viscosity of the preparation to be tested is sufficiently high so as to preclude the examination by either test method, a quantitative dilution with an appropriate diluent may be made to viscosity.
B. Particulate contamination : Visible particles
Particulate contamination of injections and infusions consists of extraneous, mobile un dissolved particles, other than gas bubbles, unintentionally present in the solutions
The test is intended to provide a simple procedure for the visual assessment of the quality of parenteral solutions as regards visible particles
Injection BP
Uniformity of dosage units
Single-dose suspensions for injection or if specified in the monograph should comply with the test.
Dosage forms Type Sub Type Dose and Ratio of active substances ≥ 25 mg or ≥ 25% < 25mg or < 25%
Solids in single dose container
Single component
mv mv
Multiple component
Solutions freeze dried in final container
mv Mv
Others cu cu Solutions enclosed single dose container
mv mv
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND MEDICINES Quality Control Department
GENERAL TESTS - PARENTERAL PREPARATIONS As Per British Pharmacopoeia
359
a. Uniformity of Content :
Limit 1. For suspensions of active substance
less than 2 mg or less than 2% of total mass
Powders for Injections or Infusions with content of active substance less than 2 mg or less than 2% of the total mass, or with a unit mass equal to or less than 40 mg comply with test. If the preparation contains more than one active substance, the requirement applies only to that substance that corresponds to the above conditions.
2. Unit mass equal to or less than 40 mg
Active substances less than 2 mg or less than 2% of the total mass or otherwise stated in the monograph comply with the test.
3. Mass Variation :
Weigh 10 individual containers and calculate the active substance for each container using the formula.
X1 = 1 x A/
X1 = Estimated individual content of active substances
1 = Individual mass of dosage unit
A = Assay value (content of active substance)
= Average weight
Ref: Page 10
Criteria
Sample meet the requirement if the acceptance value of 1st ten dosage units is less than or equal to L1%. If the acceptance value is greater than L1, test the next 20 dosage units and calculate the acceptance value. The requirement are met if the final acceptance value of 30 dosage units is less than or equal to L1% and no individual / content of the dosage unit is less than
[1-(L2) (.01)] m or more than 1 + (L2) (.01)] m
L1 is 15.0, L2 is 25.0 and m is mean of individual contents expressed as percentage of label claim.
Sterility
BET / Pyrogens
Any preparation where the label states that it is free from Bacterial Endotoxin or a pyrogenic complies with the test.
Note: BET: If the single dose is 15 ml or more comply with the test.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND MEDICINES Quality Control Department
GENERAL TESTS - PARENTERAL PREPARATIONS As Per British Pharmacopoeia
360
1. Extractable volume
Single dose, multiple doses, large volume parenterals.
No. of containers Limit a. Single dose 10 ml or more 1 Not less than the nominal
volume taken individually or collectively
More than 3 ml and less than 10 ml
3
3 ml or less 5 b. Multi dose 1 Each syringe (dose)
delivers not less than the stated dose.
Extractable volume
Limit: The volume is not les than the nominal volume in case of containers examined individually.
In case of containers with a nominal volume of 2 ml or less, is not less than the sum of the nominal volumes of the containers taken collectively.
Multi dose containers:
For injections in multi dose containers select one container and proceed as directed for single dose containers, using the same number of separate syringe assemblies as the number of doses specified.
Limit: The volume is such that each syringe delivers not less than the stated also.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND MEDICINES Quality Control Department
GENERAL TESTS - PARENTERAL PREPARATIONS As Per British Pharmacopoeia
361
POWDERS FOR INJECTION BP
I. Particulate contamination; sub-visible particles
Powders for parenteral use are reconstituted with particle free water or with an appropriate solvent without contamination of particles when particle free water is not suitable.
Ref: Injection Uniformity of dosage unit BET: STERILITY: Uniformity of Dosage Unit
Ref :
Limit 1. For suspensions of active
substance less than 2 mg or less than 2% of total mass
Powders for Injections or Infusions with content of active substance less than 2 mg or less than 2% of the total mass, or with a unit mass equal to or less than 40 mg comply with test. If the preparation contains more than one active substance, the requirement applies only to that substance that corresponds to the above conditions.
2. Unit mass equal to or less than 40 mg
Table: Injections
A. Uniformity of Contents :
Powders for Injections or Infusions with content of active substance less than 2 mg or less than 2% of the total mass, or with a unit mass equal to or less than 40 mg comply with test. If the preparation contains more than one active substance, the requirement applies only to those substances that correspond to the above conditions.
Limit: The preparation complies with the test if each individual content is between 85% and 115% of the average content.
The preparation fails to comply with the test if more than one individual content is outside these limits or if one individual content is outside the limits of this to 125% of the average content.
If one individual content is outside the limits of 85% - 115% but within the limits of 75% to 125%, determine the individual contents of another 20 dosage units taken at random.
The preparation complies with the test if not more than one of the individual contents of the 30 units is outside 85% to 115% of the average content and none is outside the limits of 75% - 125% of the average content.
Uniformity of Mass:
Powders for injections or infusions comply with the test for uniformity of mass of single dose preparations.
If the test for uniformity of content is prescribed for all the active substances, the test for uniformity of mass is not required.
When required for the Assay of a powder for injection, determine the weight of the contents of 10 containers as described in the test for uniformity of weight.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND MEDICINES Quality Control Department
GENERAL TESTS - PARENTERAL PREPARATIONS As Per British Pharmacopoeia
362
Limit:
Weigh individually 20 units taken at random or, for single dose preparations presented in individual containers, the contents of 20 units, and determine the average mass not more than 2 of the individual masses deviate from the average mass by more than the percentage deviation and none deviates by more than twice that percentage.
(Uniformity of weight (mass) Table GENERAL CHART
Pharmaceutical Form Average mass Percentage Deviation
Tablets (uncoated and film coated)
8 mg or less more than 80 mg and less than 250 mg or more
10 7.5 5
Capsules, granule (uncoated, single dose) and powders (single –dose)
Less than 300 mg 10 300 mg or more 7.5
Powders for parenteral use (single dose)
More than 40 mg 10
Suppositories and pessaries All masses 5 Powders for eye drops Les than 300 mg 10
Application of content uniformity and mv test for dosage forms B.P. (GENRAL CHART)
Dosage Forms Type Sub-type Dose and ratio of active substance
≥ 25 mg & ≥ 25%
< 25 mg or <25%
Tablets Uncoated mv cu Coated Film coated mv cu Others cu cu Capsules Hard mv cu Soft Suspensions,
emulsions, gels cu cu
Solutions mv cu Solids in single dose containers
Single component
mv mv
Multiple component
Solutions freeze dried in final container
mv mv
Other cu cu Solutions enclosed in single dose containers
mv mv
Others cu cu
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND MEDICINES Quality Control Department
GENERAL TESTS - PARENTERAL PREPARATIONS As Per British Pharmacopoeia
363
Capsules, powders other than for parenteral use, granules, suppositories, pessaries. BP
The preparation complies with the test if NMT one individual content is outside the limits of 85% - 15% of the average content and none is outside the limits of 75% - 125% of the average content.
The preparation fails to comply with the test if more than 3 individual contents are outside the limits of 85% - 115% of the average content or if one or more individual contents are outside the limits of 75% - 125% of the average content.
If two or three individual contents are outside the limits of 85 – 115% but within the limits of 75 – 125% determine the contents of another 20 dosage units.
The preparation complies with the test if NMT 3 individual contents of the thirty units are outside the limits of 85 – 115% of the average content.
III. BET
IV. STERILITY
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND MEDICINES Quality Control Department
GENERAL TESTS - PARENTERAL PREPARATIONS As Per British Pharmacopoeia
364
INFUSION BP
a) Extractable volume
Select one container. Transfer the contents into dry measuring cylinder
Limit: The volume is not less than the nominal volume
Ref: Page 1
b) Particulate contamination; sub-visible particles
c) Sterility :
d) BET :
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND MEDICINES Quality Control Department
GENERAL TESTS - PARENTERAL PREPARATIONS As Per United States Pharmacopeia
365
INJECTION USP
1. Volume in container for single dose / multi dose / large volume intravenous infusion
2. Foreign and particulate matter
3. Sterility
4. Uniformity of content only for suspensions, emulsions and gels in single dose container
5. BET if specified
Powders for Injection
1. Completeness and clarity of solution – Constituted Solution
2. Particulate matter – Constituted Solution
3. Sterility
4. Uniformity of dosage units – At variation for freeze dried
CU for pure drug 5 excipients
5. BET if specified
Infusions
1. Volume in container
2. Foreign and particulate matter
3. Sterility
4. BET if specified
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND MEDICINES Quality Control Department
GENERAL TESTS - PARENTERAL PREPARATIONS As Per United States Pharmacopeia
366
A. Volume in container
I. Single does containers :
Volume of Container No. of containers
10 ml or more 1
More than 3 ml and less than 10 ml 3
3 ml or loss 5
2 ml or less
Contents to be poled to obtain a volume required for measurement. Use separate syringe for each container.
10 ml or more Empty the container directly in to a graduated cylinder.
Result: Volume is not less than the nominal volume in case of containers xxxxx
In case of containers with nominal volumes of the containers taken collectively.
II. Multi-dose containers
Select 1 container and proceed as directed for single dose containers, using the same number of separate syringe assembles as the number of doses specified.
Result: Each syringe deliver not less than the stated dose
III. Large volume intravenous solutions :
Select 1 container and transfer the contents to a dry measuring cylinder
Result: The value is not less than the nominal volume.
B. Foreign and particulate matter, Same as BP page 1-4
Evaluation Chart
1.
Evaluation Sample Particle size Maximum number of particles
Preparation in containers with a nominal volume
Equal to greater than
Average number of particles present in the units
More than 100 ml 10 µm 25 per ml 25 µm 3 per ml
Less than 100l 10 µm 6000 per container 25 µm 600 per container
100ml 10 µm 6000 per container 25 µm 600 per container
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND MEDICINES Quality Control Department
GENERAL TESTS - PARENTERAL PREPARATIONS As Per United States Pharmacopeia
367
2. Evaluation Sample Particle size Maximum number of
particles Preparation in containers with a nominal volume
Equal to greater than
Average number of particles present in the units
More than 100 ml 10 µm 25 per ml 25 µm 3 per ml
Less than 100l 10 µm 6000 per container 25 µm 600 per container
100ml 10 µm 6000 per container 25 µm 600 per container
3.
100ml 10 µm 25/ml per 25 µm 3/ml
Microscopic particle count Evaluation chart 1 Sample Particle
size Maximum number of particles
Preparation in containers with a nominal volume
Equal to or greater than
Average number of particles present in the units
More than 100 ml 10 µm 12 per ml 25 µm 2 per ml
Less than 100l 10 µm 3000 per container 25 µm 300 per container
100ml 10 µm 3000 per container 25 µm 300 per container
2 Sample Particle
size Maximum number of particles
Preparation in containers with a nominal volume
Equal to or greater than
Average number of particles present in the units
More than 100 ml 10 µm 12 per ml 25 µm 2 per ml
Less than 100l 10 µm 3000 per container 25 µm 300 per container
100ml 10 µm 3000 per container 25 µm 300 per container
3.
Sample Particle size
Maximum number of particles
100ml 10 µm 12/ml 25 µm 2/ml
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND MEDICINES Quality Control Department
GENERAL TESTS - PARENTERAL PREPARATIONS As Per United States Pharmacopeia
368
C. Uniformity of dosage units
1. Weight variation
Dosage forms Type Sub Type Dose and Ratio of active substances ≥ 25 mg or ≥ 25% < 25mg or < 25%
Solids in single dose container
Single component
mv mv
Multiple component
Solutions freeze dried in final container
mv Mv
Others cu cu Solutions enclosed single dose container
mv mv
>25mg <25mg Freeze dried solids and suspension, emulsion or gel for systemic use only, packaged in single unit container
cu cu
Solns. For inhalations packed in glass or plastic ampule inhalation use as nebulizer and oral solutions packed in unit dose container and in to soft capsule
Xxxx Xxxxx
2. CU :
1. For powders for which at variation is not applicable
2. coated tablets other than film coated 25 mg or more of drug or 25% w/w
3. Suspensions, emulsion or gels in single unit containers for systemic administration
4. Tbulatins other than nebulizers at variation
Solutions for inhalations used in nebulizers, oral solutions packed in unit dose containers, soft capsule, solids – freeze dried solids (including sterile solids) in single unit containers having added sustain.
Tables, capsule, film coated tabs contain more than 25 mg or 25% w/w of active substance
Criteria: Same as BP
D. BET
E. STERILITY
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Quality Control Department
GENERAL TESTS - SUTURES
369
SUT-Table 1. Diameter and Tensile Strength of (Collagen Absorbable) Sutures
Limits on Average Diameter
(mm) knot-Pull Tensile
Strength (kgf) Knot-Pull Tensile strength
(in N)
USP Size
Metric Size
(Gauge no:). Min. Max.
Limit on average
Min.
Limit on individual
strand Min.
Limit on average
Min.
limit on individual
starnd Min. 9-0 0.4 0.04 0.049 _ _ _ _ 8-0 0.5 0.05 0.069 0.045 0.025 0.44 0.24 7-0 0.7 0.07 0.099 0.07 0.055 0.69 0.54 6-0 1 0.1 0.149 0.18 0.1 1.76 0.98 5-0 1.5 0.15 0.199 0.38 0.2 3.73 1.96 4-0 2 0.2 0.249 0.77 0.4 7.55 3.92 3-0 3 0.3 0.339 1.25 0.68 12.2 6.67 2-0 3.5 0.35 0.399 2 1.04 19.6 10.2 0 4 0.4 0.499 2.77 1.45 27.2 14.2 1 5 0.5 0.599 3.8 1.95 37.3 19.1 2 6 0.6 0.699 4.51 2.4 44.2 25.5 3 7 0.7 0.799 5.9 2.99 57.8 29.3 4 8 0.8 0.899 7 3.49 68.6 34.2
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Quality Control Department
GENERAL TESTS - SUTURES
370
SUT-Table 2. Diameter and Tensile Strength of Synthetic Suture (Absorbable Synthetic)
Limits on average
diameter (mm)
Knot- Pull Tensile Strength (in kgf) (except where
otherwise specified)* Limit on average
Min.
Knot- Pull Tensile Strength (in N) (except where
otherwise specified)
USP size Min. Metric size (Gauge
no:) Max. Min. Max. 12-0 0.01 0.001 0.009 _ _ 11-0 0.1 0.01 0.019 _ _ 10-0 0.2 0.02 0.029 0.025* 0.24* 9-0 0.3 0.03 0.039 0.050* 0.49* 8-0 0.4 0.04 0.049 0.07 0.69 7-0 0.5 0.05 0.069 0.14 1.37 6-0 0.7 0.07 0.099 0.25 2.45 5-0 1 0.1 0.149 0.68 6.67 4-0 1.5 0.15 0.199 0.95 9.32 3-0 2 0.2 0.249 1.77 17.4 2-0 3 0.3 0.339 2.68 26.3 0 3.5 0.35 0.399 3.9 38.2 1 4 0.4 0.499 5.08 49.8 2 5 0.5 0.599 6.35 62.3
3 and 4 6 0.6 0.699 7.29 71.5 5 7 0.7 0.799 _ _
* The tensile strength of the specified USP size is measured by straight pull.
SUT-Table 3. Matching Solutions (Extractable Colour)
Parts of each CS per 10 parts of total volume.
Color of suture (Extractable color)
Cobaltous Chloride CS Ferric Chloride CS Cupric Sulphate CS
Yellow - Brown 0.2 1.2 _
Pink - Red 1 _ _
Green - Blue _ _ 2
Violet 1.6 _ 8.4
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Quality Control Department
GENERAL TESTS - SUTURES
371
Limits on average diameter (mm)
Limits on average Knot-Pull (Except where otherwise specified)a Tensile Strength (in
kgf)b
Limits on average Knot-Pull (except where otherwise specified)a Tensile
Strength (in N)b
USP size Metric size (gauge no:) Min. Max. Class I Min. Class II Min.
Class III Min. Class I Min.
Class II Min.
Class III Min.
12-0 0.01 0.001 0.009 0.001a _ 0.002a 0.01a _ 0.02a
11-0 0.1 0.01 0.019 0.006a 0.005a 0.02a 0.06a 0.05a 0.20a
10-0 0.2 0.02 0.029 0.019a 0.014a 0.06a 0.194a 0.14a 0.59a
9-0 0.3 0.03 0.039 0.043a 0.029a 0.07a 0.424a 0.28a 0.68a
8-0 0.4 0.04 0.049 0.06 0.04 0.11 0.59 0.39 1.08
7-0 0.5 0.05 0.069 0.11 0.06 0.16 1.08 0.59 1.57
6-0 0.7 0.07 0.099 0.2 0.11 0.27 1.96 1.08 2.65
5-0 1 0.1 0.149 0.4 0.23 0.54 3.92 2.26 5.3
4-0 1.5 0.15 0.199 0.6 0.46 0.82 5.88 4.51 8.04
3-0 2 0.2 0.249 0.96 0.66 1.36 9.41 6.47 13.3
2-0 3 0.3 0.339 1.44 1.02 1.8 14.1 10 17.6
0 3.5 0.35 0.399 2.16 1.45 3.40a 21.2 14.2 33.3a
1 4 0.4 0.499 2.72 1.81 4.76a 26.7 17.8 46.7a
2 5 0.5 0.599 3.52 2.54 5.90a 34.5 24.9 57.8a
3 and 4 6 0.6 0.699 4.88 3.68 9.11a 47.8 36.1 89.3a
5 7 0.7 0.799 6.16 _ 11.4a 60.4 _ 112a
6 8 0.8 0.899 7.28 _ 13.6a 71.4 _ 133a
7 9 0.9 0.999 9.04 _ 15.9a 88.6 _ 156a
8 10 1 1.099 _ _ 18.2a _ _ 178a
9 11 1.1 1.199 _ _ 20.5a _ _ 201a
10 12 1.2 1.299 _ _ 22.8a _ _ 224a
a The tensile strength of sizes smaller than USP size 8-0 (Metric size 0.4) is measured by straight pull. The tensile strength of sizes larger than USP size 2-0 (metric size 3) of monofilament class III (metallic) Non absorbable surgical suture is measured by straight pull. Silver wire meets the tensile strength values of class I sutures but is tested in the same manner as class III sutures.
b The limits on Knot-Pull tensile strength applied to Non absorbable surgical suture that has been sterilized. For non sterile sutures of class I and class II , the limits are 25% higher.
KKMMSSCCLL QUALITY CONTROL MANUAL FOR
DRUGS AND SUPPLIES Quality Control Department
GENERAL TESTS - SUTURES
372
SUT-Table 5.
Standard Needle Attachment for Absorbable and Nonabsorbable Sutures
Metric Size (Gauge number) Limits on Needle Attachment
Absorbable collagen Suture
Non absorbable
and synthetic absorbable
sutures USP size Average (in kgf) (Min.)
Individual (in kgf)(Min.)
Average (In N)(Min.) Individual (in N)(Min)
0.1 11-0 0.007 0.005 0.069 0.049
0.2 10-0 0.014 0.01 0.137 0.098
0.4 0.3 9-0 0.021 0.015 0.206 0.147
0.5 0.4 8-0 0.05 0.025 0.49 0.245
0.7 0.5 7-0 0.08 0.04 0.784 0.392
1 0.7 6-0 0.17 0.08 1.67 0.784
1.5 1 5-0 0.23 0.11 2.25 1.08
2 1.5 4-0 0.45 0.23 4.41 2.25
3 2 3-0 0.68 0.34 6.67 3.33
3.5 3 2-0 1.1 0.45 10.8 4.41
4 3.5 0 1.5 0.45 14.7 4.41
5 4 1 1.8 0.6 17.6 5.88
6 and larger 5 and larger 2 and larger 1.8 0.7 17.6 6.86
SUT- Table 6.
Removable Needle Attachment for Absorbable and Non absorbable Sutures
Metric Size (Gauge number) Limits on Needle Attachment
Absorbable collagen Suture
Non absorbable and synthetic absorbable
sutures USP size Minimum(in kgf) Maximum (in
kgf) Minimum (in N) Maximum (in
N)
1.5 1 5-0 0.028 1.59 0.274 15.6
2 1.5 4-0 0.028 1.59 0.274 15.6
3 2 3-0 0.028 1.59 0.274 15.6
3.5 3 2-0 0.028 1.59 0.274 15.6
4 3.5 0 0.028 1.59 0.274 15.6
5 4 1 0.028 1.59 0.274 15.6
6 5 2 0.028 1.59 0.274 15.6
373
REFERENCES
Indian Pharmacopoeia
British Pharmacopoeia
United States Pharmacopoeia
British Pharmaceutical Codex
National formulary
ISO
ISI
Drugs and Cosmetic Act
Remington
I.M. Finar
374
ABBREVATIONS
G –CAP General tests Capsules
G-CRE General tests Creams
G-EAR General tests Ear /Eye drops
G-EYO General tests Eye ointments
G-GEL General tests Gels
G-NAS General tests Nasal drops/solutions/sprays
G-OIN General tests Ointments
G-ORA General tests Oral liquids
G-ORP General tests Oral powders
G-PES General tests Pesseries
G-SUP General tests Suppositories
G-TAB General tests Tablets
IP Indian Pharmacopoeia
BP British Pharmacopoeia
USP United States Pharmacopoeia
BPC British Pharmaceutical Codex
NFI National formulary
NLT Not less than
NMT Not more than