A4 PHARMA CATALOG - Copy · 2020. 11. 18. · Impurity : Individual impurity Any other unspeciied...
Transcript of A4 PHARMA CATALOG - Copy · 2020. 11. 18. · Impurity : Individual impurity Any other unspeciied...
PHARMADIVISION
GASTROINTESTINAL
ANTI-OBESITY
NEUROLOGICAL
ANTI-DEPRESSANT
CARDIOVASCULAR
UROLOGICAL
ANTI-INFECTIVE
DIGESTIVEENZYME
NEUTRALPELLETS
ANTI-INFLAMMATORY
1-5
6
7
12
14-15
17-18
19-22
ENDICRINOLOGY
RESPIRATORY
23-25
13
16
16
8-9
10-11
MOUTHDISSOLVINGFILMS
VITAMINS&MINERALS
26
E IN NCAPSULAT O
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GASTROINTESTINALDRUGPELLETS
OMEPRAZOLEECMUPS
USP
Medium:0.1Nhydrochloricacid;500mlRPM:100
Apparatus:2
Time:2Hours
Medium:PhosphateBuffer;900mlpH7.6
Dissolution
>85%-
NMT15%
NMT75%(Q)
ofLAofOmeprazole
ofLAofOmeprazole
USPAssay 90TO110% ofLAof
Omeprazole
Dissolved
Dissolved
CompliesbyHPLC
NMT5%
USP
USP
USP
USP
Identi�ication:
LossonDrying
Availablesizes:
PhysicochemicalTests
ParticleSizeDistribution
RPM:100Apparatus:2
AvailablePercentage: 8.5%,20%,22.22%
Appearances IHstandardHard, brittle, free �lowing,spherical masses
BulkDensityNLT0.5gm/cc
14-20#,30-60#
ESOMEPRAZOLEMAGNESIUMDRMUPS
AvailablePercentage: 8.5%,11%,22.5%
Appearances IHstandardHard, brittle, free �lowing,spherical masses
>85%- USP
Medium:0.1Nhydrochloricacid;300mlRPM:100Apparatus:Paddle
Time:2Hours
Medium:PhosphateBuffer;700ml
Impurities NMT (%)
Omeprazole-OmeprazoleSulfonea 0.5
Anyotherindividualimpurity0.2Totalimpurities 2
NLT10%(Q)
NLT80%(Q)
ofLAofEsomeprazole
ofLAofEsomeprazole
Dissolved
Dissolved
ComplybyHPLCDissolution:
NMT5%USP
USP
USP
USP
USP
Identi�ication:A
LossondryingBulk DensityNLT0.6gm/cc
Availablesizes:
PhysicochemicalTests
ParticleSizeDistribution
RPM:100Apparatus:Paddle
Time:30min
USPAssay 90TO110% ofLAofEsomeprazole
14-20#,30-60#
GASTROINTESTINALDRUGPELLETS
3
PANTOPRAZOLESODIUMDRMUPS
AvailablePercentage:15%,20%
Appearances IHstandardHard, brittle, free �lowing ,spherical masses
>85%-
Medium:0.1Nhydrochloricacid;1000mlRPM:75Apparatus:2Time:120minMedium:PhosphateBuffer;pH6.81000ml
Impurities NMT(%)
Pantaprazole
Anyotherindividualimpurities0.21.0
0.5C
0.50.3
Totalimpurities
-
Assay
NLT10%
NLT75%(Q)
ofLAofPantoprazole
ofLAofPantoprazole
90TO110% ofLAof
Pantoprazole
Dissolved
Dissolved
Dissolution:NMT5%
USP
USP
USP
USP
USP
Losson ryingDBulkDensityNLT0.6gm/cc
Availablesizes:
PhysicochemicalTests
ParticleSizeDistribution
Identi�ication Shall Comply byHPLC
RPM:75Apparatus:2Time:30min
relatedcompoundsDaandfb
PantaoprazolerelatedcompoundBePantaoprazolerelatedcompoundAd
14-20#,30-60#
LANSOPRAZOLEMUPS
AvailablePercentage:8.5%,12.5%,15%
Appearances IHstandardHard, brittle, free �lowing ,spherical masses
>85%
90TO110%
NMT0.5gm/cc
NMT5%
USP
Medium:0.1Nhydrochloricacid;500mlRPM:75Apparatus:2Time:60min
Medium:PhosphateBuffer;PH6.8900ml
Impurities NMT(%)LansoprazoleN-oxide
LansoprazolerelatecompoundA(Lansoprazolesulfone)
0.4
0.1
Assay
NMT10%
NLT80%(Q)
ofLAofLansoprazole
ofLAofLansoprazole
ofLAofLansoprazole
Dissolved
Dissolved
CompliesbyUV
Dissolution:
USP
USP
USP
USP
USP
Identi�ication:A
Identi�ication:BComplies byHPLC
Lossondrying
BulkDensity
Availablesizes:14-20#,30-60#
PhysicochemicalTests
ParticleSizeDistribution
RPM:75Apparatus:2
Time:60min
-
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GASTROINTESTINALDRUGPELLETS
4
MESALAMINEERPELLETS
85%>- USP
14-20#
AvailablePercentage: 90%,96.38%
1hr=between5%and25%
2hrs=between30%and50%
4hrs=between60%and90%
8hrsnotlessthan85%
Assay 90TO110% USP
USP
ofLAofMesalamine%
CompliesbyIR
Medium:0.05MPhosphateBuffer
Identi�ication
LossonDrying
BulkDensity
ParticleSizeDistribution
RPM:100
Apparatus:2
Time:1,2,4,8HOURS
pH:7.5
Dissolution
NMT5% USP
USP
USP
Appearances
NLT5gm/cc
Availablesizes:
PhysicochemicalTests
IHstandardHard,brittle,free�lowing,sphericalmasses
DEXLANSAPRAZOLEERPELLETS
AvailablePercentage: 17%,20%,22.5%DDR
Appearances
Availablesizes:14-20#,30-60#
PhysicochemicalTests
IHstandardHard,brittle,free�lowing,sphericalmasses
Identi�ication CompliesbyHPLC
LossOnDrying NMT5.0%
Bulk Density NMT0.5gm/cc
Dissolution
NMT10%oflabeledclaimofdrugreleasedin1Hrs.
NLT80%oflabeledclaimofdrugreleasedin1Hrs
ResidualSolventsNMT5000ppmNMT600ppm
Assay
ParticleSizeDistribution
Medium:0.1Nhydrochloricacid;500mlRPM:75Apparatus:2Time:60min
Medium: Phosphate Buffer;PH6.8900ml
RPM:75Apparatus:2
IsopropylalcoholMethylenedichloride
Time:60min
90TO110% ofLAofDexlansaprazole
USP
USP
USP
USP
USP
>85%-
Itopridepellets
Linaclotidepellets 0.09%,0.25%
60%
AVAILABLEDRUGPELLETS
DrugPellets(IR/ER/SR) %
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GASTROINTESTINALDRUGPELLETS
5
MEBEVERINEHCLSRPELLETS
Physicochemical
Hard,brittle,free�lowing,whitecoloursphericalmasses
Odorless
Appearances
Odor
IHStandard
IHStandard
Identi�ication complybyHPLC>85%- USP
BulkDensity NLT0.5gm/cc USPUSP
USP
USP
USP
ParticleSizeDistribution
AvailablePercentage:55%,60%,80%
AvailableSizes:14-20#
Dissolution:
Medium1:0.1NHCL
Medium2:pH6.8Buffer
900ml
Time: 1
3
8Hr
RPM:100Apparatus:paddle
USPLossOnDrying NMT5.0%
USPResidualorganicsolvents
OrganicImpurities
NMT0.5%Individual impurities
Total impurities NMT1.0%
IPA-NMT5000PPMMDC-NMT500PPM
After1Hr-10%-30%
After3Hr-30%-60%
After8Hr-NLT70%
MicropbialLimitTest
Totalaerobic microbualcountNMT100cfu/gmTotal yeast &mould countNMT 10cfu/gmEscherichia coliAbsent in1gm
Salmonella Absent in10gm
RABEPRAZOLEECPELLETS
Physiochemical
Hard,brittle,free�lowing,whitecoloursphericalmasses
Odorless
Appearances
Odor
IHStandard
IHStandard
Identi�ication:A complybyHPLC
>85%- USP
BulkDensity NLT0.5gm/cc USP
USP
USP
USP
ParticleSizeDistribution
AvailablePercentage:55%,60%,80%
AvailableSizes:14-20#
Dissolution:
USPLossOnDrying NMT5.0%
Medium:0.1Nhydrochloride
acid;500ml
Time: 60min
RPM:75Apparatus:2
NMT10%ofL.Aof
Rabeprazole
Medium:PhosphateBuffer
pH6.8;900ml
Time:60min
Assay 90.0 to110.0ofLaamount of
Rabeprazole
RPM:75Apparatus:2
NLT70%ofL.Aof
Rabeprazole
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ANTI-OBESITYDRUGPELLETS
6
RELEASE CONTROL POLYMER
DRUG LAYER
CORE GRANULES
PROTECTIVE COATINGADDITIONAL CONTROL POLYMER
ORLISTATDRUGPELLETS
>85%-
AvailablePercentage:
Medium:3%Sodiumlaurylsulfateand0.5%sodiumchlorideinwater(pH6.0);900ml
RPM:75Apparatus:2Time:45min
orlistatopenringepimer1.5orlistatopenringb
b
d
a
0.3orlistatrelatedcompoundD1.0Hexylundecylpyranone0.2
Henicosenylleucinate0.3
Anyotheridenti�ied impurity
0.3
Totalimpurities3.0Individualunidenti�iedimpurity0.2
Assay
50%,60%
NLT75%(Q) ofLAoforlistatDissolved
CompliesbyHPLC
Dissolution:
NMT5% USP
USP
USP
USP
USP
Identi�ication
Appearances
LossonDryingBulkDensityNLT5gm/cc
Availablesizes:
PhysicochemicalTests
ParticleSizeDistribution
IHstandardHard,brittle,free�lowing,sphericalmasses
Impurities
NMT(%)
USP90TO110% ofLAofOrlistat
14-20#
FENOFIBRATEIRPELLET
Physicochemical
Hard,brittle,free�lowing,whitecoloursphericalmassesAppearances IHStandard
Identi�ication:A
Identi�ication:B
complybyHPLC
complybyUV
BulkDensity NLT0.5gm/cc
>85%- USP
USP
USP
USP
USP
USP
USP
USP
USP
ParticlesizeDistribution
Dissolution
Medium:0.05Msodiumlaurylsulfateinwater
1000ml
Time:40min
Impurity:
Individualimpurity
Anyotherunspeci�ied
Impurity
TotalImpurity
Impurity
Assay
NMT0.5%FORFeno�ibraterelatedcompoundB
NMT0.2%
NMT2.0%
RPM:75Apparatus:2
LossOnDrying NMT5.0
90TO110% ofLAofFeno�ibrate
NLT70%ofLAofamountFeno�ibratedissolved
AvailablePercentage:50%,66.23%,75%SR
Availablesizes:14-20#
Feno�ibricAcidDR 29%
Cholinefeno�ibratepellets 60%
AVAILABLEDRUGPELLETS
DrugPellets(IR/ER/SR) %
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7
ANTI-DEPRESSANTDRUGPELLETS
VENLAFAXINEHYDROCHLORIDEERPELLETS
>85%
90TO110%
- USP
USP
Medium:Water;900ml
RPM:100Apparatus:1
Time:3hrs6hrs35%-60%16hrs60%-85%24hrsNLT75%
NMT 40%
Impurity:
IndividualImpurityNMT0.2%TotalImpurityNMT0.5%Assay ofLAofVenlafaxine
Hydrochloride
Dissolution
NMT5% USP
USP
USP
USPUSP
CompliesbyUVIdenti�ication:A
CompliesbyHPLCIdenti�ication:B
LossonDrying
BulkDensityNLT0.5gm/cc
Availablesizes:14-20#,30-60#
PhysicochemicalTests
ParticleSizeDistribution
AvailablePercentage: 33%
Appearances IHstandardHard,brittle,free�lowing,sphericalmasses
Sertralinepellets 25%,50%
AVAILABLEDRUGPELLETS
DrugPellets(IR/ER/SR) %
DULOXETINEDRPELLETS
USP
a-Naphthol
Anyindividualunspeci�ieddegradationproduct
NMT0.2%NMT0.2%0.2%
Impurities
AssayTotal impurities
CompliesbyIRCompliesbyHPLC
Dissolution:
NMT5% USP
USP
USP
USP
Identi�ication:AIdenti�ication:B
LossondryingBulkDensityNLT5gm/cc
Availablesizes:14-20#
PhysicochemicalTests
ParticleSizeDistribution
AvailablePercentage:9%,14.85%,17%,17.65%,22.5%
Appearances IHstandardHard,brittle,free�lowing,sphericalmasses
Medium:water1000mlsolution;1000mlRPM:100Apparatus:1Detector:UV232mmTime:2hours
USP
NLT10%ofLAofDuloxetineDissolved
Medium: pH6.8Phophate Buffer1000mlRPM:100Apparatus:1Detector:UV232nmTime:90min
NLT75%(Q)ofLAofDuloxetineDissolved
Duloxetinerelated compoundHC
NMT0.4%90TO110% ofLAof Duloxetine
>85%-
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DICLOFENACSODIUMERPELLETS
90TO110%
>85%-USP
USP
AvailablePercentage:
Medium:0.05MPhosphate
Buffer pH7.5;900ml
RPM:50
Apparatus:2
Time: 1hrs5hrs45%-65%
10 hrs65%-85%75%-95%16
24hrshrsNLT80%
15%-35%
Assay
33%,37%,40%,52%
ofLAofDiclofenac sodium
Dissolution:
USP
USP
CompliesbyHPLC
CompliesbyTLC
USP
USP
Identi�ication:A
Identi�ication:B
Appearances
BulkDensityNLT0.5gm/cc
Availablesizes:14-20#
PhysicochemicalTests
ParticleSizeDistribution
IHstandardHard,brittle,free�lowing,sphericalmasses
8
ASPIRINDRPELLETS
>85%- USP
USP
Medium: Buffer pH6.8;
Impuritieslimit offree salicylic acidNMT3%
RPM:100
RPM:100
Apparatus:1
Apparatus:1
Time:90min
Time:90min
Analyticalwavelength;280mm
Analyticalwavelength;265mm
Assay
NMT10%
NLT75%(Q)
ofLAofAspirin
ofLAofAspirin
93.0TO107% ofLAofAspirin
Dissolved
Dissolved
Dissolution:
USP
USP
USP
ShallComplybyHPLC
ShallComplybyIR
USP
USP
Identi�ication:A
Identi�ication:B
Bulk DensityNLT0.5gm/cc
LossonDryingNMT0.5
Availablesizes:14-20#,30-60#
PhysicochemicalTests
ParticleSizeDistribution
AvailablePercentage: 50%,65%
Appearances IHstandardHard,brittle,free�lowing,sphericalmasses
ANTI-INFLAMMATORYDRUGPELLET
Medium: 0.1Nhydrochloride
and0.2Mtribasicsodiumphosphate(3:1500ml)
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9
ANTI-INFLAMMATORYDRUGPELLET
IBUPROFENDRUGPELLET
>85%
AvailablePercentage:80%,90%
Appearances
Availablesizes:14-20#,30-60#
PhysicochemicalTests
BulkDensity
Water
Identi�ication:AParticleSizeDistribution
Identi�ication:B
Medium:phosphatebufferpH7.2,700ml
IHstandardHard,brittle,free�lowing,sphericalmasses
ShallcomplybyUV
ShallcomplybyHPLC
NLT0.5gm/cc
NMT5%
RPM:50
Apparatus:2
Time:60min complybyUV
NLT80%(Q)ofLAofIbuprofen
Assay 93.0TO107% ofLAofIbuprofen
Dissolved
Dissolution:
USPUSP
USP
USP
USP
USP
USP
-
KETOPROFENSRPELLET
AvailablePercentage: 60%,65%,70%
Appearances
AvailableSizes:14-20#,30-60#
PhysicochemicalTests
ParticlesizeDistributionIdenti�ication:A
Identi�ication:B
BulkDensity
LossinDrying
Dissolution
IHstandardHard,brittle,free�lowing,sphericalmasses
ShallcomplybyHPLC
ShallcomplybyUV
NLT0.5gm/cc
NMT5.0%
Medium: PhosphateBuffersolution;1000ml
RPM:50
Apparatus:2Detector:UV258mmTime: 110-25%
55-80%4
8HrNLT80%
NLT80%(Q)ofLAofKetoprofen
Assay 90TO110% ofLAofKetoprofen
Dissolved
USPUSP
USP
USP
USP
USP
USP
>85%-
6.8
DimethyleFumaratePellets
IndomethacinPellets
FlurbiprofenSRPellets
BudesonideECPellets
DiclofenacpottasiumEC
Nimusulide
PiroxicamPellets
27%
60%
0.9%
50%
48%
0.02%
CalecoxibPellets 55%
50%
AVAILABLEDRUGPELLETS
DrugPellets(IR/ER/SR) %
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CARDIOVASCULARDRUGPELLETS
90TO110%
>85%- USP
USP
AvailablePercentage:
Assay
1.236%,1.73%,2.04%,2.5%
ofLAof
Nitroglycerin
Medium:WaterDissolution:
USP
CompliesbyHPLC USPIdenti�ication:A
Appearances
USPLossonDryingNMT5%
Bulk Density0.8 - 0.9gm/cc
Availablesizes:14-20#
PhysicochemicalTests
ParticleSizeDistribution
IHstandardHard,brittle,free�lowing,sphericalmasses
RPM:120Apparatus:2Time: 25% to50%
60% to90%NLT80%
1hr4hr8hr12hr NLT85%
NITROGLYCERINSRPELLETS
10
NIFEDIPINEERPELLETS
>85%- USP
USP
AvailablePercentage:
Medium:1.25%Sodiumlauryl
sulfateinwater900ml
RPM:100Apparatus:2Time:1hrs
2hrs15%-40%4hrs 35%-70%
10hrs NLT85%
NMT25%
Assay
8.6%,17.14%
90TO110% ofLAof
Nifedipine
Dissolution:
USP
USP
CompliesbyHPLCCompliesbyUV
USPUSP
Identi�ication:A
Identi�ication:B
Appearances
Loss on DryingNMT5%
Bulk Density NLT 0.5gm/cc
Availablesizes:14-20#
PhysicochemicalTests
particleSizeDistribution
IHstandardHard,brittle,free�lowing,sphericalmasses
Impurities:
NMT0.5%
Nifedipinenitrophenypyridineanalog
Nifedipinenitrosophenypyridineanalog
NMT2.0%
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CARDIOVASCULARDRUGPELLETS
METOPROLOLSUCCINATEERPELLETS
11
Physicochemical
Hard,brittle,free�lowing,whitecoloursphericalmasses
Odorless
Appearances
Odor
Availablepercentage:47%
Availablessizes:14-20#
IHStandard
IHStandard
BulkDensity NLT0.5gm/cc
>85%- USPUSP
Identi�ication:A ShallbecomplyHPLC USP
USP
USP
ParticlesizeDistribution
Dissolution
Medium:Dilute
hydrochloricacid
Time:30min
RPM:1000ml
Apparatus:1
LossOnDrying NMT5.0
USPAssay 90TO110% ofLAofPropranololHydrochloride
NLT75%ofLAofamountPropranololHydrochloride
PROPRANOLOLHYDROCHLORIDEPELLETS
EnalaprilMaleatepellets
Amlodipinepellets
Isosorbidepellets
Nicardipinepellets
Telmisartanpellets
Valsartanpellets
Diltiazempellets
5%
57%,57.15%
20%,8.69%
Carvedilolpellet 54%,20%
20%
50%
54%
10%
AVAILABLEDRUGPELLETS
DrugPellets(IR/ER/SR) %
USP
AvailablePercentage:
Medium:pH6.8Phosphate
Buffer; 500ml
RPM:50Apparatus:2
Time:1hrs4hrs20%-40%8hrs40%-60%20hrsNLT80%
NMT25%
Assay
60%,65%
90TO110% ofLAofMetoprolol succinate
Dissolution:
USP
USP
CompliesbyIR
CompliesbyIRUSPUSP
Identi�ication:A
Identi�ication:BIdenti�ication:CComply byHPLC
Appearances
LossonDrying
>85%-
NMT5%Bulk DensityNLT0.5gm/cc
Availablesizes:14-20#,30-60#
PhysicochemicalTests
ParticleSizeDistribution
IHstandardHard,brittle,free�lowing,sphericalmasses
Impurities:
Total impuritiesNMT0.75%
Anyunspeci�ieddegradation productNMT0.20.%
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NEUROLOGICALPELLETS
CAFFEINEPELLETS
Physicochemical
Hard,brittle,free�lowing,whitecoloursphericalmassesAppearances IHStandard
Identi�ication
Availablesizes:14-20#
complybyHPLC
>85%- USP
BulkDensity
ResidualsolventHeavymetalsLeadArseniccadmiummercury
NLT0.5gm/ccUSP
USP
USP
ParticleSizeDistribution
Dissolution:
Medium:Water
Time:1Hr
NLT90%30min55% To85%
USPLossOnDrying NMT5.0%
<2ppm
<0.6ppm<6 ppm
<6ppm
USPMicropbialLimitTest
Total aerobic microbual countTotal yeast &mould countEscherichia coli
Salmonella
USPAssay
NMT100cfu/gm
NMT10cfu/gmAbsent in1gm
Absentin10gm
90%TO110% ofLAofCaffeine
ToMeet USPstandards for class 2andclass3solvent
AvailablePercentage:65%,85%
TOLPERISONEHCLCOATEDPELLETS
>85%-
JP
AvailablePercentage:
TotalAerobicmicrobialcount
Totalyeast&mouldcount
Escherichia coil
salmonella
NMT1000cfu/gm
NMT100cfu/gm
Absent in1gm
Absent in10gm
60%
MicrobialLimitTest JP
Medium:0.01MHCL
Relatedsubstance
RPM:75Apparatus:2Time:30min
AnyotherindividualimpurityNMT0.5%
TotalImpurityNMT1.0%
NLT85%(Q)ofLAofTolperisone
95TO105%Assay ofLAofTolperisone
Dissolved
Dissolution:
JP
JP
JP
CompliesbyHPLCJP
Identi�ication
Appearances
UntappedDensityNLT0.6TO0.7
Moisturecontent NMT3%
Availablesizes:20-80#,20-60#
PhysicochemicalTests
ParticleSizeDistribution
IHstandardHard,brittle,free�lowing,sphericalmasses
12
Carbamazepinepellets
Gabapentinpellets
Pregabalinepellets
Memantinepellets
Dabigatranpellets
75%
25%,50%,75%
16%
Aprepitantpellets 35%,40%
40%
15%,85%
AVAILABLEDRUGPELLETS
DrugPellets(IR/ER/SR) %
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13
TAMSULOSINHCLPELLETS
>85%
90TO110%
- USP
USP
AvailablePercentage:
Assay
0.133%,0.1%,0.178%,0.16%,0.2%,0.4%
ofLAofTamsulosin
Medium:pH7.2PhosphateBuffer
RPM:100Apparatus:2
Time:2hrs
RPM:100Apparatus:2Time:8hrs
38hrshrs
3hr - 47 -68%8hr- NLT80%
2hr-13-34%
USP
CompliesbyHPLC USPIdenti�ication:A
Appearances
USPLoss onDryingNMT5%
Bulk DensityNLT0.5gm/cc
Availablesizes:14-20#,30-60#
PhysicochemicalTests
ParticleSizeDistribution
IHstandardHard,brittle,free�lowing,sphericalmasses
Medium:2.0sodiumchloridein5.7mlhydrochlorideacidandaddwater500ml
Dissolution:
UROLOGICALDRUGPELLETS
TOLTERODINETARTRATEERPELLETS
Physicochemical
Hard,brittle,free�lowing,whitecoloursphericalmasses
Odorless
Appearances
Odor
IHStandard
IHStandard
>85%- USP
BulkDensity NLT0.5gm/ccUSP
Identi�ication complybyHPLC USP
USP
USP
ParticleSizeDistribution
Dissolution:
Medium :Phosphate Buffer
pH6.8;900ml
Time: 1
2
3
7
12Hr
RPM:100Apparatus:1
USPLossOnDrying NMT3.0%
USPResidualorganicsolvents
OrganicImpurities
Individual impurities NMT0.5%
Total impurities NMT0.1%
IPA-NMT5000PPMMDC-NMT500PPM
1Hr-NMT25%
2Hr-betwwen20%to50%
3Hr-betwwen40%to75%
7Hr-betwwen55%to80%
12Hr-NLT70%
AvailablePercentage:2.1%
Availablesizes:14-20#
products protected by valid patents are not offered for sale in countries where the sale of such products constitutes patent infringement. availability may be restricted to certain markets or countries.
Tamsulosin+DutasteridePellets
OxybutyninSRPellets
HydrochlorothiazidePellets 12.5%,20%
5.55%
0.4mg+0.5mg
AVAILABLEDRUGPELLETS
DrugPellets(IR/ER/SR) %
CLARITHROMYCINTASTEMASKINGGRANULES
>85%
USP
AvailablePercentage:
WaterNMT5%
Whitetoslightlyoffwhitefree�lowinggranulesfreefromanyvisibleforeignparticles,whichafterreconstitutiongivesawhitetooffwhitecolored,�lavored&bitterlesssuspension
pH(afterreconstitution)Limit:8.5to11.0
Assay
27%
90TO110% ofLAof
Clarithromycin
CompliesbyHPLC
USP
USPIdenti�ication
Appearances
Bulk DensityNLT0.6gm/cc
Availablesizes:20-60#
PhysicochemicalTests
ParticlesizeDistribution
Description
IHstandardHard,brittle,free�lowing,sphericalmasses
ANTI-INFECTIVEDRUGPELLETS
14
ITRACONAZOLEPELLETS
>85%
AvailablePercentage:
Medium:0.25%(w/w)sodiumlaurylsulfate in0.1NHCL;900ml
NLT80%(Q) of LAof amountIntraconazole
RPM:75Apparatus:2Time:45min
Impurities
AnyIndividualimpurities0.2%Totalimpurities1.50%
22%,33%,35%,40%
90TO110% USPAssay ofLAofItraconazole
CompliesbyHPLC
Dissolution:
NMT5% USPUSP
USP
USP
Identi�ication:AIdenti�ication:BComply byUV
Appearances
LossondryingBulk DensityNLT5gm/cc
Availablesizes:14-20#
PhysicochemicalTests
ParticleSizeDistribution
IHstandardHard,brittle,free�lowing,sphericalmasses
products protected by valid patents are not offered for sale in countries where the sale of such products constitutes patent infringement. availability may be restricted to certain markets or countries.
ANTI-INFECTIVEDRUGPELLETS
FLUCONAZOLEPELLETS
>85%
USP
AvailablePercentage:
Medium:Water;900mlNLT75%(Q)of LA ofamountFluconazoleisdissolvedRPM:50
Apparatus:2
Time:45min
Assay
50mg,150mg
90TO110% ofLAofFluconazole
CompliesbyHPLC
Dissolution:
NMT5%USP
USP
USP
Identi�ication
Appearances
LossonDryingBulkDensityNLTgm/cc5
Available sizes :14-20#,30-60#
PhysicochemicalTests
ParticleSizeDistribution
IHstandardHard,brittle,free�lowing,sphericalmasses
15
MinocyclinePellets
NitrofurantoinPellets 50%,35%
35%,25%
AVAILABLEDRUGPELLETS
DrugPellets(IR/ER/SR) %
MinocyclinePellets
NitrofurantoinPellets 50%,35%
35%,25%
AVAILABLEDRUGPELLETS
DrugPellets(IR/ER/SR) %
AZITHROMYCINTASTEMASKINGGRANULES
>85%
USP
AvailablePercentage:
WaterNMT1.5%w/w
Whitetoslightlyoffwhitefree�lowinggranulesfreefromanyvisibleforeignparticles,whichafterreconstitutiongivesawhitetooffwhitecolored,�lavored&bitterlesssuspension
pH(afterreconstitution)Limit:8.5 to11.0
Assay
90%
90TO110% ofLAof Azithromycin
CompliesbyHPLC
USP
USPIdenti�ication
Appearances
Bulk DensityNLT0.6gm/cc
Availablesizes:20-60#
PhysicochemicalTests
ParticlesizeDistribution
Description
IHstandardHard,brittle,free�lowing,sphericalmasses
products protected by valid patents are not offered for sale in countries where the sale of such products constitutes patent infringement. availability may be restricted to certain markets or countries.
16products protected by valid patents are not offered for sale in countries where the sale of such products constitutes patent infringement. availability may be restricted to certain markets or countries.
ENDOCRINOLOGYDRUGPELLET
RESPIRATORYDRUGPELLET
METFORMINHYDROCHLORIDESRPELLETS
THEOPHYLLINEERPELLETS
>85%
90TO110% USP
AvailablePercentage:80%,90%
Medium:pH6.8PhosphateBuffer
solution;1000ml
RPM:100
Apparatus:2
Detector:UV232nm
310
Time :1 hour
hourshours
20-40%45-65%NLT85%
Impurities
Individual impuritiesNMT 0.1%
Total impuritiesNMT 0.6%
Assay ofLAofMetformin
Hydrochloride
CompliesbyHPLC
Dissolution:
NMT5%
USP
USP
USP
USP
Identi�icationA
Appearances
LossonDrying
Bulk DensityNLT 5gm/cc
Availablesizes:14-20#,30-60#
PhysicochemicalTests
ParticleSizeDistribution
IHstandardHard,brittle,free�lowing,sphericalmasses
-
Dutasteridepellets0.5%
AVAILABLEDRUGPELLETS
DrugPellets(IR/ER/SR) %
Physicochemical
Hard,brittle,free�lowing,whitecoloursphericalmassesAppearances IHStandard
Identi�ication:A
Identi�ication:B
Bulk Density NLT0.5gm/cc
LossonDrying NMT 5.0
ShallbeComplyUV
ShallbeComplyHPLC
>85%- USP
USP
USP
USP
ParticlesizeDistribution
USPAssay
Availablepercentage:60%,75%,89.25%
Availablesizes:14-20#
USPDissolution:Medium:4.5PhosphateBuffer;900ml
RPM:75Apparatus:2
Time :1hrBetween 10% to30%2hrBetween 30% to55%
Between 55% to80%4hr8hrNLT80%
90TO110%ofLAofTheophylline
DIGESTIVEENZYMESPELLETS
17
PANCREATINECPELLETS40000USP
>85%- USP
Medium:0.1Nhydrochlorideacid;900ml
RPM:100Apparatus:paddle
Time: 2hrs
Medium:BufferpH6.8;900ml500ml
RPM:100Apparatus:paddle
Time:45min
NLT75%ofLipaseActivity
AssayEach750mgpelletscontainpancreatin480mg
Lipase ActivityNLT40,000 USPUnitsAmylase activity NLT1,04,375 USPUnits
protease activityNLT1,00,000 USPUnitspathogentestsEscherichiacoliAbsent in 1gmSalmonella Absent in10gm
Dissolution:
USP
USP
CompliesbyUV USP
USP
Identi�ication
Appearances
Loss onDryingNMT5%
Bulk Density NLT0.5gm/cc
Availablesizes:14-20#,20-40#,20-60#
PhysicochemicalTests
ParticleSizeDistribution
IHstandardHard,brittle,free�lowing,sphericalmasses
PANCREATINECPELLETS25000USP
>85%- USP
Medium:0.1Nhydrochlorideacid;900ml
RPM:100Apparatus:paddle
Time: 2hrs
Medium:bufferpH6.8;900ml900ml
RPM:100Apparatus:paddle
Time:45min
NLT75%ofLipaseActivity
AssayEach500mgpelletscontainpancreatin 300mgNLT74700 USP .Unitsamylase activityNLT25000 USPUnitsprotease activityNLT62500 USPUnitspathogentestsescherichia colisalmonella
Absent in1gmAbsent in 10gm
Dissolution:
USP
USP
CompliesbyUV USP
USP
Identi�ication
Appearances
LossonDryingNMT5%
Bulk Density NLT0.5gm/cc
Availablesizes:14-20#,20-40#,20-60#
PhysicochemicalTests
ParticleSizeDistribution
IHstandardHard,brittle,free�lowing,sphericalmasses
PANCREATINECPELLETS10000USP
>85%- USP
Medium:0.1Nhydrochlorideacid;900ml
RPM:100Apparatus:paddle
Time: 2hrs
Medium:bufferpH6.8;900ml500ml
RPM:100Apparatus:paddle
Time: 45min
NLT 75%ofLipaseActivity
AssayEach250mgpelletscontainpancreatin150mg
Lipase ActivityNLT10,000 USPUnitsAmylase Activity NLT33400USPUnits
protease ActivityNLT37500 USPUnitspathogenTestsEscherichia ColiAbsent in1gmSalmonella Absent in 10gm
Dissolution:
USP
USP
CompliesbyUV USP
USP
Identi�ication
Appearances
Losson DryingNMT5%
Bulk Density NLT0.5gm/cc
Availablesizes:14-20#,20-40#,20-60#
PhysicochemicalTests
ParticleSizeDistribution
IHstandardHard,brittle,free�lowing,sphericalmasses
products protected by valid patents are not offered for sale in countries where the sale of such products constitutes patent infringement. availability may be restricted to certain markets or countries.
PANCREATINECPELLETS10000EP
>85%-ph.Eur
ph.Eur
ph.Eur
ph.Eur
ph.Eur
ph.Eurph.Eur
Medium:0.1Nhydrochlorideacid;900ml
RPM:100Apparatus:paddle
Time: 2hrs
Medium:bufferpH6.8;900ml500ml
RPM:100Apparatus:paddle
Time: 45min
NLT75%ofLipaseActivity
AssayEach250mgpelletscontainpancreatin150mg
Lipase ActivityNLT 10000 ph.EurAmylase Activity NLT8000ph.Eur
protease ActivityNLT 600ph.EurpathogenTestsEscherichiaColiAbsent in1 gmSalmonella Absebt in10gm
Dissolution:CompliesbyUVIdenti�ication
Appearances
LossonDryingNMT5%
Bulk Density NLT0.5gm/cc
Availablesizes:14-20#,20-40#,20-60#
PhysicochemicalTests
ParticleSizeDistribution
IHstandardHard,brittle,free�lowing,sphericalmasses
PANCREATINECPELLETS25000EP
>85%- ph.Eur
ph.Eur
ph.Eur
ph.Eur
ph.Eur
ph.Eur
Medium:0.1Nhydrochlorideacid;900ml
RPM:100Apparatus:paddle
Time:2hrs
Medium:BufferpH6.8;900ml500ml
RPM:100Apparatus:paddle
Time: 45min
NLT75%ofLipaseActivity
AssayEach500mgpelletscontainpancreatin300mg:
Lipase ActivityAmylase Activity
protease ActivityNLT25000ph.EurNLT18000ph.Eur
NLT1000ph.EurpathogenTestsEscherichiaColiSalmonella
Absent in1gmAbsebt in10gm
Dissolution:CompliesbyUVIdenti�ication
Appearances
LossonDryingNMT5%
BulkDensity NLT0.5gm/cc
Availablesizes:14-20#,20-40#,20-60#
PhysicochemicalTests
ParticleSizeDistribution
IHstandardHard,brittle,free�lowing,sphericalmasses
PANCREATINECPELLETS40000EP
>85%- ph.Eur
ph.Eur
ph.Eur
ph.Eur
ph.Eur
ph.Eur
Medium:0.1Nhydrochlorideacid;900ml
RPM:100Apparatus:paddle
Time: 2hrs
Medium:BufferpH6.8;900ml500ml
RPM:100Apparatus:paddle
Time: 45min
NLT75%ofLipaseActivity
AssayEach750mgpelletscontainpancreatin480mg:
Lipase ActivityNLT40000 Ph.EurAmylase Activity NLT25000 Ph.Eur
protease ActivityNLT1600Ph.EurpathogenTestsEscherichia ColiAbsent in1gmSalmonella Absebt in10gm
Dissolution:CompliesbyUVIdenti�ication
Appearances
LossonDryingNMT5%
Bulk Density NLT0.5gm/cc
Availablesizes:14-20#,20-40#,20-60#
PhysicochemicalTests
ParticleSizeDistribution
IHstandardHard,brittle,free�lowing,sphericalmasses
DIGESTIVEENZYMESPELLETS
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NEUTRALPELLETS
MANNITOLSPHERES
LossonDrying
Identi�ication
Speci�icopticalrotation
Acidity
LossonDrying
Chloride
Sulfate
Arsenic
Reducingsugar
Heavymetal
Assay
Physicochemical
NMT0.5%
shallcompliesinfraredabsorbance0 0Between+137 and+145
NMT 0.30ml of 0.020Nsodiumhydroxideisrequiredforneutralization
NMT0.5%
NMT0.07%
NMT0.01%
NMT1ppm.
NMT0.1%
Maximum5ppm
Between96%to101%
>85%- USP/NF
USP/NF
USP/NF
USP/NF
USP/NF
USP/NF
USP/NF
USP/NF
USP/NF
USP/NF
USP/NF
USP/NF
ParticleSizeDistribution
AvailableSizes
Hard,brittle,free�lowing,whitecoloursphericalmassesAppearances IHStandard
OdorlessOdor IHStandard
Totalaerobicmicrobialcount
Salmonella
Escherichiacoli
Staphylococcusaureus
Pseudomonasaeruginosa
Microbial Test
NMT100cfu/gm
Absent
Absent
Absent
Absent
Ph.Eur./USP/NF
Ph.Eur./USP/NF
Ph.Eur./USP/NF
Ph.Eur./USP/NF
Ph.Eur./USP/NF
75-150 150-180 180-250 250-300 425-600 600-850
MAS-75 MAS-150 MAS-180 MAS-250 MAS-425 MAS-600
19
CALCIUMCARBONATESPHERES
Totalaerobicmicrobialcount
Salmonella
Escherichiacoli
Staphylococcusaureus
Pseudomonasaeruginosa
MicrobialTest
NMT100cfu/gm
Absent
Absent
Absent
Absent
LossonDrying
Identi�ication
Acidinsolublesubstance
Limitofmagnesiumandalkali
saltsShallcomplyby
Limitof�luoride
Lead
Iron
Heavymetals
Organicvolatileimpurities
Assay
Physicochemical
>85%
NMT2%
shallrespondstothetestsforcalcium
NMT10mg
NMT5mg
NMT0.005%
NMT3ppm
Shallnotexceedthanthatofstandard
solution(0.1%)
NMT0.002%
Shallmeettherequirement
Between98.0%to100.5%
- Ph.Eur./USP/NF
Ph.Eur./USP/NF
Ph.Eur./USP/NF
Ph.Eur./USP/NF
Ph.Eur./USP/NF
Ph.Eur./USP/NF
Ph.Eur./USP/NF
Ph.Eur./USP/NF
Ph.Eur./USP/NF
Ph.Eur./USP/NF
Ph.Eur./USP/NF
Ph.Eur./USP/NF
Ph.Eur./USP/NF
Ph.Eur./USP/NF
Ph.Eur./USP/NF
Ph.Eur./USP/NF
Ph.Eur./USP/NF
ParticleSizeDistribution75-212 106-212 150-300 300-500 500-710 710-850Availablesizes
CCS-75 CCS-106 CCS-150 CCS-300 CCS-710CCS-500
Hard,brittle,free�lowing,whitecoloursphericalmasses
Odorless
Appearances
Odor
IHStandard
IHStandard
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NEUTRALPELLETS
TARTARICACIDSPHERES
MicrobialTest
Ph.Eur./USP/NF
Ph.Eur./USP/NF
Ph.Eur./USP/NF
Ph.Eur./USP/NF
Ph.Eur./USP/NF
Appearances
Odor
LossonDryingIdenti�icationAsolutionstronglyacidReactionoftartaratesAppearanceofsolution
CalciumChlorideSpeci�icopticalrotationLimitofoxalateSulphateHeavyMetalsResidueonignitionAssay
Physicochemical
Hard,brittle,free�lowing,whitecoloursphericalmasses
Odorless
Ph.Eur./USP/NFPh.Eur./USP/NF
Ph.Eur./USP/NFPh.Eur./USP/NFPh.Eur./USP/NF
Ph.Eur./USP/NFPh.Eur./USP/NFPh.Eur./USP/NFPh.Eur./USP/NFPh.Eur./USP/NFPh.Eur./USP/NFPh.Eur./USP/NFPh.Eur./USP/NF
ParticleSizeDistribution
IHStandard
IHStandard
180-250 250-300 300-425 425-600 600-850500-710
Totalaerobicmicrobialcount
Salmonella
Escherichiacoli
Staphylococcusaureus
Pseudomonasaeruginosa
NMT100cfu/gm
Absent
Absent
Absent
Absent
NMT0.5%
StronglyacidicIRspectrumequivalentreferencestandardClear andnotmore intensely colored thanreference200ppm100ppm
0 0+12.0 to+12.8Complies150ppm
10ppm
0.05%99.7to100.5%
>85%-
<-<-
<-<-<-
TAS-180 TAS-250 TAS-300 TAS-425 TAS-500 TAS-600
SUGARSPHERES
>85%-
betwwen+41and+61
residue
sulfateash
onignitionNMT0.25%
0.2%
sugar
Speci�icopticalrotationin5.7mlofhydrochlorideacid
contentNLT62.5%andNMT91.5% of sucrose
Heavy metalsNMT 5.0 ppm
Microbialtest
Total aerobic microbial countNMT100cfu/gmsalmonellaAbsentsalmonellaAbsentescherichia coliAbsentstaphylococcus aureusAbsentpseudomonas aeruginosaAbsent
0%Friability
Appearances
LossonDryingBulkDensity
NMT4%NLT 0.5gm/cc
PhysicochemicalTests
ParticleSizeDistribution
IHstandardIHstandard
Hard,brittle,free�lowing,sphericalmasses
Ph.Eur./USP/NF
Ph.Eur./USP/NFPh.Eur./USP/NF
Ph.Eur./USP/NF
Ph.Eur./USP/NF
Ph.Eur./USP/NF
Ph.Eur./USP/NF
Ph.Eur./USP/NF
Ph.Eur./USP/NF
Ph.Eur./USP/NF
Ph.Eur./USP/NF
Ph.Eur./USP/NF
Ph.Eur./USP/NF
Ph.Eur./USP/NF
SSS-100 SSS-200 SSS-350 SSS-500 SSS-700 SSS-1000
100-200 200-355 350-500 500-710 710-1000 1000-1400Availablesizes
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OdorlessOdor
NEUTRALPELLETS
LACTOSESPHERES
Physicochemical
Hard,brittle,free�lowing,whitecoloursphericalmasses
Odorless
Appearances
Odor
IHStandard
IHStandard
Ph.Eur./USP/NF
Ph.Eur./USP/NF
Ph.Eur./USP/NF
Ph.Eur./USP/NF
Ph.Eur./USP/NF
LMS-180 LMS-250 LMS-300 LMS-425 LMS-600 LMS-850
LossondryingIdenti�ication:A
Identi�ication:BResidueonignition
Speci�icopticalrotation
NMT2%CompliesIR
CompliesTLCNMT0.1%
HeavyMetals NMT5g/g0 0+54.4 to+55.9
Acidity&Alkalinity NMT 0.4 ml of0.1N sodiumhydroxide required toproducedaredcolor
Lossondrying NMT0.5%
>85%- USP/NFUSP/NF
USP/NFUSP/NF
USP/NF
USP/NFUSP/NF
USP/NF
USP/NF
ParticlesizeDistribution
Protein &light absorbingNMT0.25 inthe range of210-220 &NMT0.07intherange of270-300mm
Impurities
Sulfatedash
Microbialtest
Salmonella Absent
Escherichia coli Absent
staphylococcus aureus Absent
Pseudomonas aeruginosa Absent
AbsentTotalaerobicmicrobialcount
Water 4.5%to5.5%
NMT0.1%
180-250 250-300 300-425 425-600 600-850 850-1000Availablesizes
CITRICACIDSPHERES
Physicochemical
Hard,brittle,free�lowing,whitecoloursphericalmasses
Odorless
Appearances
Odor
IHStandard
IHStandard
LossonDrying
Identi�ication
Residueonignition
HeavyMetals
Sulfate
Limitofoxalic
Water
Assay
NMT2%
ShallComplyUSP
NMT0.1%
NMT10ppm
ShallcomplyUSP
ShallcomplyUSP
NMT1%
99.5%to100.5%oflabeledamount
>85%- USP/NF
USP/NF
USP/NF
USP/NF
USP/NF
USP/NF
USP/NF
USP/NF
USP/NF
ParticlesizeDistribution
Totalaerobicmicrobial
count
Salmonella
Escherichiacoli
Staphylococcusaureus
Pseudomonasaeruginosa
MicrobialTest
NMT100cfu/gm
Absent
Absent
Absent
Ph.Eur./USP/NF
Ph.Eur./USP/NF
Ph.Eur./USP/NF
Ph.Eur./USP/NF
Ph.Eur./USP/NF
300-425 425-600 600-850 850-1000 1000-1180 1400-1700
CAS-300 CAS-425 CAS-600 CAS-850 CAS-1000 CAS-1400
Availablesizes
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MCCSPHERES
NEUTRALPELLETS
22
SILICASPHERES
Totalaerobicmicrobialcount
Salmonella
Escherichiacoli
Staphylococcusaureus
Pseudomonasaeruginosa
MicrobialTest
NMT100cfu/gm
Absent
Absent
Absent
Absent
Ph.Eur./USP/NF
Ph.Eur./USP/NF
Ph.Eur./USP/NF
Ph.Eur./USP/NF
Ph.Eur./USP/NF
Lossondrying
Identi�ication
pH
Lossondrying
LossonIgnition
Organicvolatileimpurities
Heavymetals
Assay
Physicochemical
>85%
NMT0.5%
shallproduceddeepyellowcolor
4to8
NMT5.0%
NMT805%
meetstherequirement
NMT0.0037%
90%to110%oflabeledamount
- USP/NF
USP/NF
USP/NF
USP/NF
USP/NF
USP/NF
USP/NF
USP/NF
USP/NF
ParticlesizeDistribution75-212 106-212 150-300 300-500 710-850
SDS-75 SDS-106 SDS-150 SDS-300 SDS-710
Availablesizes
Hard,brittle,free�lowing,whitecoloursphericalmasses
Odorless
IHStandard
IHStandard
Appearances
Odor
Totalaerobicmicrobialcount
Salmonella
Escherichiacoli
Staphylococcusaureus
Pseudomonasaeruginosa
MicrobialTest
NMT100cfu/gm
Absent
Absent
Absent
Absent
Ph.Eur./USP/NF
Ph.Eur./USP/NF
Ph.Eur./USP/NF
Ph.Eur./USP/NF
Lossondrying
Bulkdensity
Friability
Identi�ication
ZincChlorideTest
Degreeofpolymerizations
pHValue
Conductivity/cm/S
Ethersolublesubstances
Watersolublesubstances
Heavymetals
Sulfatedash
Physicochemical
>85%
NMT7.0%
0.5gm/cc(forinformationonly)
0%
Passes
NMT350
5.0-7.0
NMT75
NMT0.05%
NMT0.24%
NMT0.001%
NMT0.05%
- Ph.Eur./USP/NF
Ph.Eur./USP/NF
IHStandard
Ph.Eur./USP/NF
Ph.Eur./USP/NF
Ph.Eur./USP/NF
Ph.Eur./USP/NF
Ph.Eur./USP/NF
Ph.Eur./USP/NF
Ph.Eur./USP/NF
Ph.Eur./USP/NF
Ph.Eur./USP/NF
Ph.Eur./USP/NF
ParticleSizeDistribution75-212 106-212 150-300 300-500 710-810500-710
MCS-75 MCS-106 MCS-150 MCS-300 MCS-500 MCS-710
Availablesizes
Hard,brittle,free�lowing,whitecoloursphericalmasses
Odorless
IHStandard
IHStandard
Appearances
Odor
products protected by valid patents are not offered for sale in countries where the sale of such products constitutes patent infringement. availability may be restricted to certain markets or countries.
23
VITAMINSANDMINERALS
ASCORBICACIDIRPELLETS
Physicochemical
Hard,brittle,free�lowing,whitecoloursphericalmasses
Odorless
Appearances
Odor
IHStandard
IHStandard
Identi�ication:A
Identi�ication:B
Identi�ication:C
shallcomply
shallcomply
shallcomply
BulkDensity NLT0.5gm/cc
>85%- USP
USP
USP
USP
USP
ParticlesizeDistribution
AvailablePercentage:90%
Availablesizes:14-20#
Dissolution
Medium:Water;900ml
Time:45min
RPM:50
Apparatus:2
LossOnDrying NMT5.0
USPAssay 90TO110% ofLAofAscrobicAcid
NLT75%(Q)ofLAofamountAscrobicAciddissolved45MIN
FERROUSSULFATEIRPELLETS
Physicochemical
Hard,brittle,free�lowing,whitecoloursphericalmasses
Odorless
Appearances
Odor
IHStandard
IHStandard
Identi�ication shallbecomply
BulkDensity NLT0.5gm/cc
>85%- USP
USP
USP
USP
USP
ParticlesizeDistribution
Dissolution:
Medium:0.1
hydrochloricacid;900ml
Time:45min
RPM:50
Apparatus:2
LossOnDrying NMT5.0
USPAssay 90TO110% ofLAofFerrousSulphate
NLT75%(Q)ofLAofamountFerroussulfate
Availablesizes:14-20#
Availablepercentage:75%,90%
products protected by valid patents are not offered for sale in countries where the sale of such products constitutes patent infringement. availability may be restricted to certain markets or countries.
24
FOLICACIDPELLETS
Physicochemical
Hard,brittle,free�lowing,whitecoloursphericalmasses
Odorless
Appearances
Odor
IHStandard
IHStandard
Identi�ication
Bulk Density NLT0.5gm/cc
LossonDrying NMT5.0
complybyUV
>85%- USP
USP
USP
USP
ParticlesizeDistribution
Dissolution:Medium:Water500ml
RPM:50Apparatus:2
NLT75%ofLAofFolicAcid
Assay90% to115.0%of laamountofFolicAcid
Availablepercentage:50%
Availablesizes:14-20#
Time:45min
DRIEDFERROUSSULPHATE&FOLICACIDPELLETS
VITAMINSANDMINERALS
Physicochemical
Hard,brittle,free�lowing,whitecoloursphericalmasses
Odorless
Appearances
Odor
IHStandard
IHStandard
Identi�ication:Folic
Identi�ication:Iron
Identi�ication:Sulphate
BulkDensityNLT0.8to1.00gm/cc
LossonDryingNMT3.5
ShallbeComply
ShallbeComply
ShallbeComply
>85%-
USP
USP
USP
USP
ParticlesizeDistribution
USPAssayDried ferrous sulphate (150mg) NLT90.0% andNMT120.0%Folicacid (0.5mg) NLT90.0% oflabel claimMicrobiallimitTestTotal aerobic microbial test NMT1000 cfu/gmTotalcombinedmolds&yeast NMT100cfu/gmPathogens Shallbeabsent
Availablepercentage:50%
Availablesizes:14-20#
USPDissolution:Medium:PhosphateBufferpH7.4
RPM:100Apparatus:1
Time :1hrBetween 15.0% to45.0%2hrBetween35.0%to80.0%4hrNLT70%
Carbonyl+IronFolicAcid+
VitaminEPellets
MenthaPiperitaECoilPellets
ALAPelletsFolicAcid
Ferrous+Folic
PolysaccharideIronPellets
ZincSulphatePellets+VitaminCPellets
+50mg
40%
25%
75%2%,5%
150mgSR+0.5mg
23.7%
61.8mg0.5mg+
AVAILABLEDRUGPELLETS
DrugPellets(IR/ER/SR) %
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25
VITAMINSANDMINERALS
FERROUSGLYCINESULPHATEECPELLETS
Physicochemical
Hard,brittle,free�lowing,whitecoloursphericalmasses
Odorless
Appearances
Odor
IHStandard
IHStandard
Identi�ication complybyUV
>85%- USP
BulkDensity NLT0.5gm/ccUSP
USP
USP
USP
USP
USP
ParticlesizeDistribution
AvailablePercentage:60%
Availablesizes:14-20#
Dissolution:
Dissolution:
Medium:0.1MHCL900ml
Time: 2Hr
RPM:100
Medium:bufferpH6.8
900ml
Time:45min
RPM:100Apparatus:paddle37c+0.5c_
USPLossOnDrying NMT5.0%
NMT15%inAcid
NLT75%Buffer
MicropbialLimitTest
Total aerobic microbual countTotal yeast &mould countEscherichia coli
Salmonella
Assay90%to110%ofLaamount.
NMT100cfu/gmNMT10cfu/gmAbsent in1gm
Absentin10gm
CARBONYLIRONSRPELLETS
Physicochemical
Hard,brittle,free�lowing,whitecoloursphericalmasses
Odorless
Appearances
OdorIHStandard
IHStandard
Identi�icationCarbonylIron
FolicAcid
complybyUV
complybyHPLC
>85%- USP
BulkDensity NLT0.5gm/ccUSP
USP
USP
USP
USP
ParticlesizeDistribution
Dissolution
Medium:0.1MHCL/900ml
RPM:50
Apparatus:Basket
Time:1Hr
2Hr
4Hr
USPLossOnDrying NMT5.0%
Between15%to45%
Between35%to80%
NLT70%
MicropbialLimitTest
Total aerobicmicrobualcountTotal yeast &mould countEscherichiacoli
Salmonella
Assay90% to110% ofLaamount.
NMT100cfu/gmNMT10cfu/gmAbsent in1gm
Absentin10gm
AvailablePercentage:50%
Availablesizes:14-20#
products protected by valid patents are not offered for sale in countries where the sale of such products constitutes patent infringement. availability may be restricted to certain markets or countries.
Products protected by valid Patents are not offered for sale in Countries where the sale of such Products constitutes patent infringement. Availability may be restricted to
certain markets or Countries. 26
MOUTHDISSOLVINGFILMS
SILDENAFILCITRATESTRIPS
Length
Width
Thickness
Folding enduranceNLT 3Folds
SurfacepH
Uniformityofwt
Identi�ication
Uniformityofcontent
Disintegrationtime
Dissolution
Assay90%TO 110%OF LA
Physiochemical
110+15
25to35mm
20to30mm
135 to145
4TO8
tobecomplies
ComplybyHPLC
between85%to115%
Notmorethan5min
Notlessthan75%
- Ph.Eur./USP/NF
Ph.Eur./USP/NF
Ph.Eur./USP/NF
Ph.Eur./USP/NF
Ph.Eur./USP/NF
Ph.Eur./USP/NF
Ph.Eur./USP/NF
Ph.Eur./USP/NF
Ph.Eur./USP/NF
Ph.Eur./USP/NF
Ph.Eur./USP/NF
Ph.Eur./USP/NF
AverageWeight
DoseAvailable:25mg,50mg,100mg
Bluecoloredstrip IHstandardsAppearance
TADALAFILSTRIPS
Length
Width
Thickness
Folding enduranceNLT 3 Folds
SurfacepH
Uniformityofwt
Identi�ication
Uniformityofcontent
Disintegrationtime
Dissolution
Assay90%TO 110%OF LA
Physicochemical
25to35mm
20to30mm
85to95micrones
4TO8
Tobecomplies
ComplybyHPLC
between85%to115%
Notmorethan5min
Notlessthan75%
DoseAvailable:10mg,20mg
80mg+15%-AverageWeight USP
USP
USP
USP
USP
USP
USP
USP
USP
USP
USP
USP
Yellowcoloredstrip IHstandards
IHstandards
Appearance
Odor Odorless
27
BRANDASSOCIATEDWITHUS
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Survey No. 146, H. No.1 (PT),Vasai Phata Highway Junction, Pelhar,NH8, Vasai (E) - 401 208, Maharashtra (India).
Tel. : +91-9152014793/94/96/97/98/99E-mail : [email protected] : www.umangpharmaceuticals.com | www.micro-pellets.com
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