European Directorate for the Quality of Medicines | - … · 2020. 10. 1. ·...

EUROPEAN PHARMACOPOEIA 10.0 Index

1. General notices ......................................................................... 32.1. Apparatus ............................................................................. 152.1.1. Droppers ........................................................................... 152.1.2. Comparative table of porosity of sintered-glass filters.. 152.1.3. Ultraviolet ray lamps for analytical purposes............... 152.1.4. Sieves ................................................................................. 162.1.5. Tubes for comparative tests ............................................ 172.1.6. Gas detector tubes............................................................ 172.2. Physical and physico-chemical methods.......................... 212.2.1. Clarity and degree of opalescence of liquids ................ 212.2.10. Viscosity - Rotating viscometer method ..................... 282.2.11. Distillation range ........................................................... 302.2.12. Boiling point................................................................... 312.2.13. Determination of water by distillation ........................ 312.2.14. Melting point - capillary method................................. 322.2.15. Melting point - open capillary method ....................... 332.2.16. Melting point - instantaneous method........................ 332.2.17. Drop point ...................................................................... 332.2.18. Freezing point................................................................. 352.2.19. Amperometric titration................................................. 352.2.2. Degree of coloration of liquids....................................... 222.2.20. Potentiometric titration ................................................ 352.2.21. Fluorimetry..................................................................... 362.2.22. Atomic emission spectrometry .................................... 362.2.23. Atomic absorption spectrometry ................................. 372.2.24. Absorption spectrophotometry, infrared.................... 392.2.25. Absorption spectrophotometry, ultraviolet andvisible ......................................................................................... 42

2.2.26. Paper chromatography .................................................. 462.2.27. Thin-layer chromatography.......................................... 472.2.28. Gas chromatography...................................................... 482.2.29. Liquid chromatography................................................. 492.2.3. Potentiometric determination of pH............................. 242.2.30. Size-exclusion chromatography ................................... 512.2.31. Electrophoresis ............................................................... 512.2.32. Loss on drying................................................................ 572.2.33. Nuclear magnetic resonance spectrometry ................ 582.2.34. Thermal analysis ............................................................ 612.2.35. Osmolality....................................................................... 632.2.36. Potentiometric determination of ionicconcentration using ion-selective electrodes ........................ 64

2.2.37. X-ray fluorescence spectrometry ................................. 652.2.38. Conductivity ................................................................... 662.2.39. Molecular mass distribution in dextrans .................... 682.2.4. Approximate pH of solutions ......................................... 252.2.40. Near-infrared spectroscopy .......................................... 702.2.41. Circular dichroism......................................................... 752.2.42. Density of solids............................................................. 762.2.43. Mass spectrometry......................................................... 772.2.44. Total organic carbon in water for pharmaceuticaluse............................................................................................... 79

2.2.45. Supercritical fluid chromatography ............................. 802.2.46. Chromatographic separation techniques .................... 802.2.47. Capillary electrophoresis............................................... 872.2.48. Raman spectroscopy...................................................... 922.2.49. Falling ball and automatic rolling ball viscometermethods ..................................................................................... 94

2.2.5. Relative density................................................................. 252.2.54. Isoelectric focusing ........................................................ 952.2.55. Peptide mapping ............................................................ 972.2.56. Amino acid analysis..................................................... 1002.2.57. Inductively coupled plasma-atomic emissionspectrometry ........................................................................... 106

2.2.58. Inductively coupled plasma-mass spectrometry...... 1082.2.59. Glycan analysis of glycoproteins ................................ 1092.2.6. Refractive index................................................................ 262.2.61. Characterisation of crystalline solids bymicrocalorimetry and solution calorimetry........................ 115

2.2.63. Direct amperometric and pulsed electrochemicaldetection .................................................................................. 117

2.2.64. Peptide identification by nuclear magnetic resonancespectrometry ........................................................................... 118

2.2.65. Voltametric titration .................................................... 119

2.2.66. Detection and measurement of radioactivity ........... 1192.2.7. Optical rotation ................................................................ 262.2.8. Viscosity ............................................................................ 272.2.9. Capillary viscometer method ......................................... 272.3. Identification...................................................................... 1292.3.1. Identification reactions of ions and functionalgroups ...................................................................................... 129

2.3.2. Identification of fatty oils by thin-layerchromatography...................................................................... 132

2.3.3. Identification of phenothiazines by thin-layerchromatography...................................................................... 133

2.3.4. Odour .............................................................................. 1332.4. Limit tests........................................................................... 1372.4.1. Ammonium .................................................................... 1372.4.10. Lead in sugars............................................................... 1422.4.11. Phosphates .................................................................... 1422.4.12. Potassium...................................................................... 1422.4.13. Sulfates........................................................................... 1422.4.14. Sulfated ash ................................................................... 1422.4.15. Nickel in polyols........................................................... 1432.4.16. Total ash ........................................................................ 1432.4.17. Aluminium ................................................................... 1432.4.18. Free formaldehyde ....................................................... 1432.4.19. Alkaline impurities in fatty oils.................................. 1442.4.2. Arsenic............................................................................. 1372.4.20. Determination of elemental impurities..................... 1442.4.21. Foreign oils in fatty oils by thin-layerchromatography...................................................................... 147

2.4.22. Composition of fatty acids by gas chromatography.. 1472.4.23. Sterols in fatty oils........................................................ 1502.4.24. Identification and control of residual solvents ......... 1522.4.25. Ethylene oxide and dioxan.......................................... 1572.4.26. N,N-Dimethylaniline ................................................... 1582.4.27. Heavy metals in herbal drugs and herbal drugpreparations ............................................................................ 158

2.4.28. 2-Ethylhexanoic acid ................................................... 1602.4.29. Composition of fatty acids in oils rich in omega-3acids.......................................................................................... 161

2.4.3. Calcium ........................................................................... 1382.4.30. Ethylene glycol and diethylene glycol in ethoxylatedsubstances ................................................................................ 163

2.4.31. Nickel in hydrogenated vegetable oils ....................... 1632.4.32. Total cholesterol in oils rich in omega-3 acids ......... 1632.4.4. Chlorides ......................................................................... 1382.4.5. Fluorides.......................................................................... 1382.4.6. Magnesium ..................................................................... 1382.4.7. Magnesium and alkaline-earth metals ........................ 1392.4.8. Heavy metals................................................................... 1392.4.9. Iron .................................................................................. 1422,4-Dichlorobenzyl alcohol ................................................... 23902.5. Assays ................................................................................. 1672.5.1. Acid value........................................................................ 1672.5.10. Oxygen-flask method .................................................. 1702.5.11. Complexometric titrations.......................................... 1702.5.12. Water : semi-micro determination ............................. 1712.5.13. Aluminium in adsorbed vaccines .............................. 1712.5.14. Calcium in adsorbed vaccines .................................... 1722.5.15. Phenol in immunosera and vaccines......................... 1722.5.16. Protein in polysaccharide vaccines ............................ 1722.5.17. Nucleic acids in polysaccharide vaccines .................. 1722.5.18. Phosphorus in polysaccharide vaccines .................... 1722.5.19. O-Acetyl in polysaccharide vaccines ......................... 1732.5.2. Ester value....................................................................... 1672.5.20. Hexosamines in polysaccharide vaccines.................. 1732.5.21. Methylpentoses in polysaccharide vaccines.............. 1732.5.22. Uronic acids in polysaccharide vaccines ................... 1742.5.23. Sialic acid in polysaccharide vaccines ....................... 1742.5.24. Carbon dioxide in gases .............................................. 1742.5.25. Carbon monoxide in gases ......................................... 1752.5.26. Nitrogen monoxide and nitrogen dioxide in gases.. 1762.5.27. Oxygen in gases............................................................ 1762.5.28. Water in gases............................................................... 1762.5.29. Sulfur dioxide ............................................................... 177

General Notices (1) apply to all monographs and other texts 4259

Index EUROPEAN PHARMACOPOEIA 10.0

2.5.3. Hydroxyl value ............................................................... 1672.5.30. Oxidising substances ................................................... 1772.5.31. Ribose in polysaccharide vaccines ............................. 1772.5.32. Water : micro determination....................................... 1782.5.33. Total protein ................................................................. 1782.5.34. Acetic acid in synthetic peptides................................ 1812.5.35. Nitrous oxide in gases ................................................. 1822.5.36. Anisidine value............................................................. 1822.5.37. Methyl, ethyl and isopropyl methanesulfonate inmethanesulfonic acid ............................................................. 182

2.5.38. Methyl, ethyl and isopropyl methanesulfonate in activesubstances ................................................................................ 183

2.5.39. Methanesulfonyl chloride in methanesulfonicacid ........................................................................................... 184

2.5.4. Iodine value .................................................................... 1672.5.40. Methyl, ethyl and isopropyl toluenesulfonate in activesubstances ................................................................................ 185

2.5.41. Methyl, ethyl and isopropyl benzenesulfonate in activesubstances ................................................................................ 186

2.5.5. Peroxide value................................................................. 1682.5.6. Saponification value....................................................... 1692.5.7. Unsaponifiable matter ................................................... 1692.5.8. Determination of primary aromatic amino-nitrogen.................................................................................... 169

2.5.9. Determination of nitrogen by sulfuric aciddigestion .................................................................................. 170

2.6. Biological tests ................................................................... 1912.6.1. Sterility ............................................................................ 1912.6.10. Histamine...................................................................... 2002.6.11. Depressor substances................................................... 2002.6.12. Microbiological examination of non-sterile products :microbial enumeration tests.................................................. 201

2.6.13. Microbiological examination of non-sterile products :test for specified micro-organisms ....................................... 205

2.6.14. Bacterial endotoxins .................................................... 2092.6.15. Prekallikrein activator ................................................. 2132.6.16. Tests for extraneous agents in viral vaccines for humanuse............................................................................................. 214

2.6.17. Test for anticomplementary activity ofimmunoglobulin..................................................................... 216

2.6.18. Test for neurovirulence of live virus vaccines .......... 2182.6.2. Mycobacteria .................................................................. 1942.6.20. Anti-A and anti-B haemagglutinins .......................... 2182.6.21. Nucleic acid amplification techniques....................... 2192.6.22. Activated coagulation factors ..................................... 2242.6.24. Avian viral vaccines : tests for extraneous agents inseed lots ................................................................................... 224

2.6.25. Avian live virus vaccines : tests for extraneous agents inbatches of finished product ................................................... 227

2.6.26. Test for anti-D antibodies in human immunoglobu-lin.............................................................................................. 230

2.6.27. Microbiological examination of cell-basedpreparations ............................................................................ 231

2.6.30. Monocyte-activation test............................................. 2332.6.31. Microbiological examination of herbal medicinalproducts for oral use and extracts used in theirpreparation .............................................................................. 239

2.6.33. Residual pertussis toxin............................................... 2412.6.34. Host-cell protein assays............................................... 2442.6.35. Quantification and characterisation of residualhost-cell DNA ......................................................................... 248

2.6.36. Microbiological examination of live biotherapeuticproducts : tests for enumeration of microbialcontaminants........................................................................... 250

2.6.38. Microbiological examination of live biotherapeuticproducts : tests for specified micro-organisms.................... 255

2.6.7. Mycoplasmas .................................................................. 1942.6.8. Pyrogens.......................................................................... 1992.7. Biological assays ................................................................ 2612.7.1. Immunochemical methods........................................... 2612.7.10. Assay of human coagulation factor VII .................... 2802.7.11. Assay of human coagulation factor IX ...................... 2812.7.12. Assay of heparin in coagulation factors .................... 281

2.7.13. Assay of human anti-D immunoglobulin ................. 2822.7.14. Assay of hepatitis A vaccine ....................................... 2842.7.15. Assay of hepatitis B vaccine (rDNA) ......................... 2852.7.16. Assay of pertussis vaccine (acellular) ........................ 2862.7.17. Assay of human antithrombin III .............................. 2882.7.18. Assay of human coagulation factor II ....................... 2882.7.19. Assay of human coagulation factor X........................ 2892.7.2. Microbiological assay of antibiotics............................. 2622.7.20. In vivo assay of poliomyelitis vaccine (inactivated).. 2892.7.21. Assay of human von Willebrand factor..................... 2902.7.22. Assay of human coagulation factor XI ...................... 2912.7.23. Numeration of CD34/CD45+ cells in haematopoieticproducts ................................................................................... 292

2.7.24. Flow cytometry ............................................................ 2932.7.25. Assay of human plasmin inhibitor............................. 2952.7.27. Flocculation value (Lf) of diphtheria and tetanus toxinsand toxoids (Ramon assay) ................................................... 295

2.7.28. Colony-forming cell assay for humanhaematopoietic progenitor cells............................................ 296

2.7.29. Nucleated cell count and viability.............................. 2972.7.30. Assay of human protein C .......................................... 2992.7.31. Assay of human protein S ........................................... 3002.7.32. Assay of human α-1-proteinase inhibitor ................. 3002.7.34. Assay of human C1-esterase inhibitor ...................... 3012.7.35. Immunonephelometry for vaccine componentassay ......................................................................................... 301

2.7.4. Assay of human coagulation factor VIII ..................... 2682.7.5. Assay of heparin............................................................. 2692.7.6. Assay of diphtheria vaccine (adsorbed) ...................... 2692.7.7. Assay of pertussis vaccine (whole cell)........................ 2742.7.8. Assay of tetanus vaccine (adsorbed)............................ 2752.7.9. Test for Fc function of immunoglobulin..................... 2792.8. Methods in pharmacognosy ............................................ 3052.8.1. Ash insoluble in hydrochloric acid .............................. 3052.8.10. Solubility in alcohol of essential oils.......................... 3062.8.11. Assay of 1,8-cineole in essential oils.......................... 3072.8.12. Essential oils in herbal drugs...................................... 3072.8.13. Pesticide residues ......................................................... 3082.8.14. Tannins in herbal drugs .............................................. 3102.8.15. Bitterness value............................................................. 3102.8.16. Dry residue of extracts ................................................ 3112.8.17. Loss on drying of extracts........................................... 3112.8.18. Determination of aflatoxin B1 in herbal drugs ......... 3112.8.2. Foreign matter ................................................................ 3052.8.20. Herbal drugs : sampling and sample preparation .... 3132.8.21. Test for aristolochic acids in herbal drugs ................ 3142.8.22. Determination of ochratoxin A in herbal drugs ...... 3162.8.23. Microscopic examination of herbal drugs ................ 3172.8.24. Foam index ................................................................... 3172.8.25. High-performance thin-layer chromatography ofherbal drugs and herbal drug preparations ........................ 318

2.8.3. Stomata and stomatal index.......................................... 3052.8.4. Swelling index................................................................. 3062.8.5. Water in essential oils .................................................... 3062.8.6. Foreign esters in essential oils ...................................... 3062.8.7. Fatty oils and resinified essential oils in essentialoils ............................................................................................ 306

2.8.8. Odour and taste of essential oils .................................. 3062.8.9. Residue on evaporation of essential oils ..................... 3062.9. Pharmaceutical technical procedures ............................. 3232.9.1. Disintegration of tablets and capsules ......................... 3232.9.10. Ethanol content ............................................................ 3392.9.11. Test for methanol and 2-propanol ............................. 3422.9.12. Sieve test........................................................................ 3432.9.14. Specific surface area by air permeability................... 3432.9.16. Flowability..................................................................... 3462.9.17. Test for extractable volume of parenteralpreparations ............................................................................ 347

2.9.18. Preparations for inhalation : aerodynamic assessmentof fine particles........................................................................ 347

2.9.19. Particulate contamination : sub-visible particles...... 3602.9.2. Disintegration of suppositories and pessaries ............ 3252.9.20. Particulate contamination : visible particles ............. 362

4260 See the information section on general monographs (cover pages)


2.9.22. Softening time determination of lipophilicsuppositories ........................................................................... 363

2.9.23. Gas pycnometric density of solids ............................. 3642.9.25. Dissolution test for medicated chewing gums ......... 3652.9.26. Specific surface area by gas adsorption ..................... 3692.9.27. Uniformity of mass of delivered doses from multidosecontainers ................................................................................ 372

2.9.29. Intrinsic dissolution..................................................... 3722.9.3. Dissolution test for solid dosage forms ....................... 3262.9.31. Particle size analysis by laser light diffraction.......... 3732.9.32. Porosity and pore-size distribution of solids bymercury porosimetry ............................................................. 377

2.9.33. Characterisation of crystalline and partially crystallinesolids by X-ray powder diffraction (XRPD) ....................... 379

2.9.34. Bulk density and tapped density of powders............ 3842.9.35. Powder fineness............................................................ 3872.9.36. Powder flow .................................................................. 3872.9.37. Optical microscopy...................................................... 3902.9.38. Particle-size distribution estimation by analyticalsieving ...................................................................................... 392

2.9.39. Water-solid interactions : determination ofsorption-desorption isotherms and of water activity......... 394

2.9.4. Dissolution test for transdermal patches .................... 3332.9.40. Uniformity of dosage units ......................................... 3982.9.41. Friability of granules and spheroids .......................... 4002.9.42. Dissolution test for lipophilic solid dosage forms ... 4012.9.43. Apparent dissolution ................................................... 4032.9.44. Preparations for nebulisation : characterisation....... 4042.9.45. Wettability of porous solids including powders....... 4062.9.47. Demonstration of uniformity of dosage units usinglarge sample sizes.................................................................... 409

2.9.49. Powder flow properties by shear cell methods......... 4112.9.5. Uniformity of mass of single-dose preparations ........ 3352.9.52. Scanning electron microscopy ................................... 4142.9.6. Uniformity of content of single-dose preparations.... 3362.9.7. Friability of uncoated tablets ........................................ 3362.9.8. Resistance to crushing of tablets .................................. 3372.9.9. Measurement of consistency by penetrometry .......... 3373.1. Materials used for the manufacture of containers ........ 4233.1.1. Materials for containers for human blood and bloodcomponents (see 3.3.1.) ......................................................... 465

3.1.10. Materials based on non-plasticised poly(vinyl chloride)for containers for non-injectable, aqueous solutions......... 437

3.1.11. Materials based on non-plasticised poly(vinylchloride) for containers for solid dosage forms for oraladministration......................................................................... 439

3.1.1.1. Materials based on plasticised poly(vinyl chloride)for containers for human blood and blood components (see3.3.2.)........................................................................................ 465

3.1.1.2. Materials based on plasticised poly(vinyl chloride) fortubing used in sets for the transfusion of blood and bloodcomponents (see 3.3.3.) ......................................................... 468

3.1.13. Plastic additives ............................................................ 4413.1.14. Materials based on plasticised poly(vinyl chloride)for containers for aqueous solutions for intravenousinfusion .................................................................................... 445

3.1.15. Polyethylene terephthalate for containers forpreparations not for parenteral use ...................................... 448

3.1.3. Polyolefins ....................................................................... 4233.1.4. Polyethylene without additives for containers forparenteral preparations and for ophthalmic preparations.. 426

3.1.5. Polyethylene with additives for containers for parenteralpreparations and for ophthalmic preparations ................... 427

3.1.6. Polypropylene for containers and closures for parenteralpreparations and ophthalmic preparations ......................... 431

3.1.7. Poly(ethylene - vinyl acetate) for containers and tubingfor total parenteral nutrition preparations .......................... 434

3.1.8. Silicone oil used as a lubricant ..................................... 4363.1.9. Silicone elastomer for closures and tubing ................. 4363.2. Containers.......................................................................... 4533.2.1. Glass containers for pharmaceutical use..................... 4533.2.2. Plastic containers and closures for pharmaceuticaluse............................................................................................. 459

3.2.2.1. Plastic containers for aqueous solutions forinfusion .................................................................................... 460

3.2.3. Sterile plastic containers for human blood andblood components (see 3.3.4.) .............................................. 471

3.2.4. Empty sterile containers of plasticised poly(vinylchloride) for human blood and blood components (see3.3.5.)........................................................................................ 473

3.2.5. Sterile containers of plasticised poly(vinyl chloride)for human blood containing anticoagulant solution (see3.3.6.)........................................................................................ 474

3.2.6. Sets for the transfusion of blood and blood components(see 3.3.7.)................................................................................ 475

3.2.8. Sterile single-use plastic syringes (see 3.3.8.) ............. 4773.2.9. Rubber closures for containers for aqueousparenteral preparations, for powders and forfreeze-dried powders.............................................................. 460

3.3. Containers for human blood and blood components, andmaterials used in their manufacture; transfusion sets andmaterials used in their manufacture; syringes .................... 463

3.3.1. Materials for containers for human blood and bloodcomponents ............................................................................. 465

3.3.2. Materials based on plasticised poly(vinyl chloride) forcontainers for human blood and blood components......... 465

3.3.3. Materials based on plasticised poly(vinyl chloride) fortubing used in sets for the transfusion of blood and bloodcomponents ............................................................................. 468

3.3.4. Sterile plastic containers for human blood andblood components .................................................................. 471

3.3.5. Empty sterile containers of plasticised poly(vinylchloride) for human blood and blood components........... 473

3.3.6. Sterile containers of plasticised poly(vinyl chloride) forhuman blood containing anticoagulant solution ............... 474

3.3.7. Sets for the transfusion of blood and bloodcomponents ............................................................................. 475

3.3.8. Sterile single-use plastic syringes ................................. 4773-O-Desacyl-4′-monophosphoryl lipid A............................ 23554. Reagents................................................................................. 4814.1. Reagents, standard solutions, buffer solutions .............. 4814.1.1. Reagents .......................................................................... 4814.1.2. Standard solutions for limit tests ................................. 5984.1.3. Buffer solutions .............................................................. 6024.2. Volumetric analysis........................................................... 6094.2.1. Primary standards for volumetric solutions ............... 6094.2.2. Volumetric solutions...................................................... 6094-Aminobenzoic acid ............................................................. 18195.1. General texts on microbiology ........................................ 6195.10. Control of impurities in substances for pharmaceuticaluse............................................................................................. 763

5.11. Characters section in monographs ............................... 7695.1.1. Methods of preparation of sterile products ................ 6195.1.10. Guidelines for using the test for bacterialendotoxins ............................................................................... 639

5.1.11. Determination of bactericidal, fungicidal or yeasticidalactivity of antiseptic medicinal products............................. 643

5.1.2. Biological indicators and related microbial preparationsused in the manufacture of sterile products........................ 622

5.12. Reference standards ........................................................ 7735.1.3. Efficacy of antimicrobial preservation ........................ 6255.14. Gene transfer medicinal products for human use ...... 7795.1.4. Microbiological quality of non-sterile pharmaceuticalpreparations and substances for pharmaceutical use......... 627

5.1.5. Application of the F0 concept to steam sterilisation ofaqueous preparations ............................................................. 628

5.15. Functionality-related characteristics of excipients...... 7935.1.6. Alternative methods for control of microbiologicalquality ...................................................................................... 628

5.16. Crystallinity ..................................................................... 7975.17. Recommendations on methods for dosage formstesting....................................................................................... 801

5.1.7. Viral safety ...................................................................... 6375.17.1. Recommendations on dissolution testing................. 8015.1.8. Microbiological quality of herbal medicinal products fororal use and extracts used in their preparation .................. 638



5.19. Extemporaneous preparation of radiopharmaceuti-cals ............................................................................................ 807

5.1.9. Guidelines for using the test for sterility..................... 6395.2. General texts on biological products .............................. 6475.20. Elemental impurities ...................................................... 8155.21. Chemometric methods applied to analytical data ...... 8195.2.1. Terminology used in monographs on biologicalproducts ................................................................................... 647

5.2.11. Carrier proteins for the production of conjugatedpolysaccharide vaccines for human use............................... 674

5.2.12. Raw materials of biological origin for the productionof cell-based and gene therapy medicinal products ........... 675

5.2.13. Healthy chicken flocks for the production of inactivatedvaccines for veterinary use .................................................... 679

5.2.14. Substitution of in vivo method(s) by in vitromethod(s)for the quality control of vaccines ........................................ 679

5.2.2. Chicken flocks free from specified pathogens for theproduction and quality control of vaccines......................... 647

5.22. Names of herbal drugs used in traditional Chinesemedicine .................................................................................. 839

5.2.3. Cell substrates for the production of vaccines for humanuse............................................................................................. 650

5.23. Monographs on herbal drug extracts (informationchapter) .................................................................................... 843

5.2.4. Cell cultures for the production of veterinaryvaccines .................................................................................... 654

5.24. Chemical imaging ........................................................... 8475.25. Process analytical technology........................................ 8555.2.5. Substances of animal origin for the production ofimmunological veterinary medicinal products .................. 656

5.2.6. Evaluation of safety of veterinary vaccines andimmunosera ........................................................................... 658

5.2.7. Evaluation of efficacy of veterinary vaccines andimmunosera ............................................................................ 661

5.2.8. Minimising the risk of transmitting animal spongiformencephalopathy agents via human and veterinary medicinalproducts ................................................................................... 661

5.2.9. Evaluation of safety of each batch of immunosera forveterinary use.......................................................................... 673

5.3. Statistical analysis of results of biological assays andtests........................................................................................... 685

5.4. Residual solvents ............................................................... 7175.5. Alcoholimetric tables........................................................ 7275.6. Assay of interferons .......................................................... 7415.7. Table of physical characteristics of radionuclidesmentioned in the European Pharmacopoeia ...................... 745

5.8. Pharmacopoeial harmonisation ...................................... 7555.9. Polymorphism ................................................................... 759

AAbacavir sulfate....................................................................... 1733Abbreviations and symbols (1.) .................................................. 3Abelmoschi corolla ................................................................. 1289Absorption spectrophotometry, infrared (2.2.24.) ................. 39Absorption spectrophotometry, ultraviolet and visible(2.2.25.) ...................................................................................... 42

Acacia ....................................................................................... 1290Acacia, dried dispersion......................................................... 1734Acamprosate calcium ............................................................. 1736Acanthopanax bark ................................................................ 1292Acarbose .................................................................................. 1736Acebutolol hydrochloride ...................................................... 1738Aceclofenac.............................................................................. 1740Acemetacin .............................................................................. 1742Acesulfame potassium............................................................ 1744Acetate trihydrate, sodium .................................................... 3797Acetazolamide......................................................................... 1745Acetic acid, glacial .................................................................. 1746Acetic acid in synthetic peptides (2.5.34.) ............................. 181Acetone .................................................................................... 1747Acetylcholine chloride ........................................................... 1748Acetylcysteine.......................................................................... 1749

β-Acetyldigoxin....................................................................... 1750Acetylene intermix (1 per cent) in nitrogen........................ 1752Acetylsalicylic acid ................................................................. 1753Acetyltryptophan, N- ............................................................. 1755Acetyltyrosine, N- ................................................................... 1757Achyranthes bidentata root ................................................... 1293Aciclovir................................................................................... 1758Acid value (2.5.1.) ..................................................................... 167Acidum picrinicum for homoeopathic preparations ......... 1698Acidum succinicum for homoeopathic preparations ........ 1698Acitretin ................................................................................... 1760Actinobacillosis vaccine (inactivated), porcine .................. 1139Activated charcoal .................................................................. 2162Activated coagulation factors (2.6.22.)................................... 224Adapalene ................................................................................ 1761Additives, plastic (3.1.13.) ....................................................... 441Adenine.................................................................................... 1762Adenosine ................................................................................ 1763Adenovirus vaccine (inactivated), canine............................ 1079Adenovirus vaccine (live), canine......................................... 1080Adipic acid............................................................................... 1765Adrenaline ............................................................................... 1766Adrenaline tartrate ................................................................. 1767Adsorption, gas, specific surface area by (2.9.26.)................ 369Aerodynamic assessment of fine particles in preparations forinhalation (2.9.18.) ................................................................. 347

Aflatoxin B1 in herbal drugs, determination of (2.8.18.) ..... 311Agar .......................................................................................... 1295Agaricus phalloides for homoeopathic preparations ......... 1699Agnus castus fruit ................................................................... 1295Agnus castus fruit dry extract ............................................... 1296Agrimony................................................................................. 1297Air, medicinal ......................................................................... 1768Air, synthetic medicinal......................................................... 1770Akebia stem ............................................................................. 1298Alanine..................................................................................... 1771Albendazole............................................................................. 1773Albumin solution, human ..................................................... 2832Alchemilla................................................................................ 1300Alcoholimetric tables (5.5.) ..................................................... 727Alcuronium chloride.............................................................. 1774Alendronate trihydrate, sodium ........................................... 3798Alexandrian senna pods ........................................................ 1622Alfacalcidol.............................................................................. 1776Alfadex ..................................................................................... 1777Alfentanil hydrochloride hydrate ......................................... 1778Alfuzosin hydrochloride ........................................................ 1780Alginate, sodium..................................................................... 3799Alginic acid.............................................................................. 1781Alimemazine hemitartrate..................................................... 1782Alkaline impurities in fatty oils (2.4.19.) ............................... 144Alkaline-earth metals and magnesium (2.4.7.)..................... 139Allantoin .................................................................................. 1783Allergen products ..................................................................... 861Allergen products, animal epithelia and outgrowths for... 1854Allergen products, Hymenoptera venoms for..................... 2908Allergen products, mites for.................................................. 3281Allergen products, moulds for .............................................. 3302Allergen products, pollens for............................................... 3583Allium sativum for homoeopathic preparations ................ 1701Allopurinol .............................................................................. 1784all-rac-α-Tocopherol............................................................... 4057all-rac-α-Tocopheryl acetate.................................................. 4059Almagate .................................................................................. 1786Almond oil, refined ................................................................ 1787Almond oil, virgin .................................................................. 1787Aloes, Barbados ...................................................................... 1301Aloes, Cape.............................................................................. 1302Aloes dry extract, standardised............................................. 1303Alovudine (18F) injection ....................................................... 1181Alphacyclodextrin .................................................................. 1777Alprazolam .............................................................................. 1788Alprenolol hydrochloride ...................................................... 1790



Alprostadil ............................................................................... 1791Alteplase for injection ............................................................ 1793Alternative methods for control of microbiological quality(5.1.6.) ...................................................................................... 628

Altizide..................................................................................... 1797Alum......................................................................................... 1798Aluminium (2.4.17.)................................................................. 143Aluminium chloride hexahydrate......................................... 1798Aluminium hydroxide, hydrated, for adsorption ............... 1798Aluminium in adsorbed vaccines (2.5.13.)............................ 171Aluminium magnesium silicate ............................................ 1799Aluminium oxide, hydrated .................................................. 1801Aluminium phosphate gel ..................................................... 1802Aluminium phosphate, hydrated.......................................... 1803Aluminium sodium silicate ................................................... 1803Aluminium stearate................................................................ 1804Aluminium sulfate.................................................................. 1806Alverine citrate........................................................................ 1807Amantadine hydrochloride ................................................... 1808Ambroxol hydrochloride ....................................................... 1809Amfetamine sulfate ................................................................ 1810Amidotrizoate, sodium .......................................................... 3800Amidotrizoic acid dihydrate ................................................. 1812Amikacin ................................................................................. 1813Amikacin sulfate ..................................................................... 1815Amiloride hydrochloride dihydrate ..................................... 1818Amino acid analysis (2.2.56.) .................................................. 100Aminobenzoic acid, 4- ........................................................... 1819Aminocaproic acid ................................................................. 1821Aminoglutethimide ................................................................ 1821Aminophylline ........................................................................ 4008Aminophylline hydrate .......................................................... 4009Aminosalicylate dihydrate, sodium...................................... 3801Amiodarone hydrochloride................................................... 1823Amisulpride............................................................................. 1825Amitriptyline hydrochloride ................................................. 1826Amlodipine besilate................................................................ 1827Ammonia (13N) injection....................................................... 1183Ammonia solution, concentrated ......................................... 1829Ammonio methacrylate copolymer (type A)...................... 1830Ammonio methacrylate copolymer (type B) ...................... 1831Ammonium (2.4.1.).................................................................. 137Ammonium bromide ............................................................. 1832Ammonium carbonicum for homoeopathic prepara-tions........................................................................................ 1701

Ammonium chloride.............................................................. 1832Ammonium glycyrrhizate ..................................................... 1833Ammonium hydrogen carbonate ......................................... 1834Amobarbital ............................................................................ 1834Amobarbital sodium .............................................................. 1835Amomum fruit........................................................................ 1304Amomum fruit, round ........................................................... 1604Amorolfine hydrochloride..................................................... 1836Amoxicillin sodium................................................................ 1838Amoxicillin trihydrate............................................................ 1840Amperometric detection, direct, and pulsed electrochemicaldetection (2.2.63.) ................................................................... 117

Amperometric titration (2.2.19.) .............................................. 35Amphotericin B ...................................................................... 1842Ampicillin ................................................................................ 1844Ampicillin sodium.................................................................. 1846Ampicillin trihydrate.............................................................. 1849Amylmetacresol ...................................................................... 1851Anacardium for homoeopathic preparations...................... 1702Anaemia vaccine (live), chicken, infectious ........................ 1122Anaesthetic ether .................................................................... 2577Analysis, thermal (2.2.34.)......................................................... 61Analytical sieving, particle-size distribution estimation by(2.9.38.) .................................................................................... 392

Anamirta cocculus for homoeopathic preparations .......... 1708Anastrozole.............................................................................. 1852Andrographis herb ................................................................. 1305Anemarrhena asphodeloides rhizome ................................. 1307

Angelica archangelica root .................................................... 1309Angelica dahurica root........................................................... 1310Angelica pubescens root ........................................................ 1312Angelica sinensis root ............................................................ 1314Animal anti-T lymphocyte immunoglobulin for humanuse........................................................................................... 1858

Animal epithelia and outgrowths for allergen products.... 1854Animal immunosera for human use ...................................... 871Animal spongiform encephalopathies, products with risk oftransmitting agents of ............................................................ 884

Animal spongiform encephalopathy agents, minimising therisk of transmitting via human and veterinary medicinalproducts (5.2.8.)...................................................................... 661

Anise oil ................................................................................... 1315Aniseed .................................................................................... 1317Anisidine value (2.5.36.) .......................................................... 182Antazoline hydrochloride...................................................... 1855Anthrax spore vaccine (live) for veterinary use.................. 1055Anthrax vaccine for human use (adsorbed, prepared fromculture filtrates)....................................................................... 947

Anti-A and anti-B haemagglutinins (2.6.20.)........................ 218Antibiotics, microbiological assay of (2.7.2.) ........................ 262Antibodies (anti-D) in human immunoglobulin, test for(2.6.26.) .................................................................................... 230

Antibodies for human use, monoclonal ................................ 878Anticoagulant and preservative solutions for human blood................................................................................................ 1856

Anticomplementary activity of immunoglobulin (2.6.17.).. 216Anti-D antibodies in human immunoglobulin, test for(2.6.26.) .................................................................................... 230

Anti-D immunoglobulin for intravenous administration,human .................................................................................... 2835

Anti-D immunoglobulin, human ......................................... 2834Anti-D immunoglobulin, human, assay of (2.7.13.) ............ 282Antimicrobial preservation, efficacy of (5.1.3.) .................... 625Antiseptic medicinal products, determination of bactericidal,fungicidal or yeasticidal activity of (5.1.11.) ....................... 643

Antiserum, European viper venom ...................................... 1174Anti-T lymphocyte immunoglobulin for human use,animal .................................................................................... 1858

Antithrombin III concentrate, human................................. 2835Antithrombin III, human, assay of (2.7.17.) ......................... 288Apis for homoeopathic preparations.................................... 1703Apomorphine hydrochloride hemihydrate ......................... 1862Apparatus (2.1.) .......................................................................... 15Apparent dissolution (2.9.43.)................................................. 403Application of the F0 concept to steam sterilisation of aqueouspreparations (5.1.5.) ............................................................... 628

Approximate pH of solutions (2.2.4.)....................................... 25Aprepitant................................................................................ 1863Aprotinin ................................................................................. 1864Aprotinin concentrated solution .......................................... 1867Arachis oil, hydrogenated...................................................... 1869Arachis oil, refined ................................................................. 1870Arginine ................................................................................... 1870Arginine aspartate .................................................................. 1871Arginine hydrochloride ......................................................... 1872Argon ....................................................................................... 1873Aripiprazole............................................................................. 1874Aristolochic acids in herbal drugs, test for (2.8.21) ............. 314Arnica flower........................................................................... 1318Arnica tincture........................................................................ 1320Arsenic (2.4.2.) .......................................................................... 137Arsenicum album for homoeopathic preparations ............ 1704Arsenious trioxide for homoeopathic preparations ........... 1704Articaine hydrochloride......................................................... 1876Artichoke leaf .......................................................................... 1321Artichoke leaf dry extract ...................................................... 1323Ascorbate, calcium ................................................................. 2045Ascorbate, sodium.................................................................. 3802Ascorbic acid ........................................................................... 1877Ascorbyl palmitate.................................................................. 1879Ash insoluble in hydrochloric acid (2.8.1.) ........................... 305



Ash leaf .................................................................................... 1324Ash, sulfated (2.4.14.)............................................................... 142Ash, total (2.4.16.) .................................................................... 143Asparagine monohydrate....................................................... 1880Aspartame................................................................................ 1881Aspartic acid............................................................................ 1883Assay of 1,8-cineole in essential oils (2.8.11.) ....................... 307Assay of diphtheria vaccine (adsorbed) (2.7.6.).................... 269Assay of heparin (2.7.5.) .......................................................... 269Assay of heparin in coagulation factors (2.7.12.) ................. 281Assay of hepatitis A vaccine (2.7.14.)..................................... 284Assay of hepatitis B vaccine (rDNA) (2.7.15.) ...................... 285Assay of human α-1-proteinase inhibitor (2.7.32.) .............. 300Assay of human anti-D immunoglobulin (2.7.13.) .............. 282Assay of human antithrombin III (2.7.17.)............................ 288Assay of human C1-esterase inhibitor (2.7.34.) .................... 301Assay of human coagulation factor II (2.7.18.)..................... 288Assay of human coagulation factor IX (2.7.11.) ................... 281Assay of human coagulation factor VII (2.7.10.).................. 280Assay of human coagulation factor VIII (2.7.4.) .................. 268Assay of human coagulation factor X (2.7.19.) ..................... 289Assay of human coagulation factor XI (2.7.22.) ................... 291Assay of human plasmin inhibitor (2.7.25.) .......................... 295Assay of human protein C (2.7.30.)........................................ 299Assay of human protein S (2.7.31.) ........................................ 300Assay of human von Willebrand factor (2.7.21.) .................. 290Assay of interferons (5.6.)........................................................ 741Assay of pertussis vaccine (acellular) (2.7.16.)...................... 286Assay of pertussis vaccine (whole cell) (2.7.7.) ..................... 274Assay of poliomyelitis vaccine (inactivated), in vivo(2.7.20.) .................................................................................... 289

Assay of tetanus vaccine (adsorbed) (2.7.8.) ......................... 275Assays (2.5.)............................................................................... 167Astragalus mongholicus root ................................................ 1325Atazanavir sulfate ................................................................... 1885Atenolol.................................................................................... 1887Atomic absorption spectrometry (2.2.23.) .............................. 37Atomic emission spectrometry (2.2.22.).................................. 36Atomic emission spectrometry, inductively coupled plasma-(2.2.57.) .................................................................................... 106

Atomoxetine hydrochloride .................................................. 1889Atorvastatin calcium trihydrate ............................................ 1890Atovaquone.............................................................................. 1892Atractylodes lancea rhizome ................................................. 1327Atractylodes rhizome, largehead .......................................... 1328Atracurium besilate ................................................................ 1894Atropine ................................................................................... 1897Atropine sulfate....................................................................... 1898Aucklandia root ...................................................................... 1329Aujeszky’s disease vaccine (inactivated) for pigs ................ 1055Aujeszky’s disease vaccine (live) for pigs for parenteraladministration....................................................................... 1057

Aurothiomalate, sodium........................................................ 3804Aurum chloratum natronatum for homoeopathicpreparations .......................................................................... 1704

Automatic rolling ball and falling ball viscometer methods(2.2.49.) ...................................................................................... 94

Avian infectious bronchitis vaccine (inactivated)............... 1059Avian infectious bronchitis vaccine (live)............................ 1060Avian infectious bursal disease vaccine (inactivated) ........ 1062Avian infectious bursal disease vaccine (live) ..................... 1063Avian infectious encephalomyelitis vaccine (live) .............. 1065Avian infectious laryngotracheitis vaccine (live)................ 1066Avian live virus vaccines : tests for extraneous agents in batchesof finished product (2.6.25.).................................................. 227

Avian paramyxovirus 1 (Newcastle disease) vaccine(inactivated) .......................................................................... 1134

Avian paramyxovirus 1 (Newcastle disease) vaccine(live) ....................................................................................... 1136

Avian paramyxovirus 3 vaccine (inactivated) for turkeys.. 1068Avian tuberculin purified protein derivative....................... 4119Avian viral tenosynovitis vaccine (live) ............................... 1069

Avian viral vaccines : tests for extraneous agents in seed lots(2.6.24.) .................................................................................... 224

Azaperone for veterinary use ................................................ 1900Azathioprine............................................................................ 1901Azelastine hydrochloride ....................................................... 1902Azithromycin .......................................................................... 1904

BB19 virus (B19V), validation of nucleic acid amplificationtechniques for the quantification of B19V DNA in plasmapools : guidelines..................................................................... 219

Bacampicillin hydrochloride ................................................. 1911Bacitracin................................................................................. 1913Bacitracin zinc......................................................................... 1917Baclofen ................................................................................... 1921Bacterial endotoxins (2.6.14.).................................................. 209Bacterial endotoxins, guidelines for using the test for(5.1.10.) .................................................................................... 639

Bactericidal, fungicidal or yeasticidal activity of antisepticmedicinal products, determination of (5.1.11.) .................. 643

Baical skullcap root ................................................................ 1331Bambuterol hydrochloride .................................................... 1922Barbados aloes ........................................................................ 1301Barbary wolfberry fruit.......................................................... 1332Barbital..................................................................................... 1923Barium chloratum for homoeopathic preparations ........... 1705Barium chloride dihydrate for homoeopathicpreparations .......................................................................... 1705

Barium sulfate ......................................................................... 1924Basic butylated methacrylate copolymer ............................. 1925BCG for immunotherapy......................................................... 948BCG vaccine, freeze-dried....................................................... 949Bearberry leaf .......................................................................... 1333Beclometasone dipropionate ................................................. 1926Beclometasone dipropionate monohydrate......................... 1929Beeswax, white ........................................................................ 1931Beeswax, yellow....................................................................... 1932Belamcanda chinensis rhizome............................................. 1334Belladonna for homoeopathic preparations........................ 1705Belladonna leaf........................................................................ 1336Belladonna leaf dry extract, standardised ........................... 1337Belladonna leaf tincture, standardised................................. 1338Belladonna, prepared ............................................................. 1339Benazepril hydrochloride ...................................................... 1932Bendroflumethiazide.............................................................. 1934Benperidol ............................................................................... 1935Benserazide hydrochloride .................................................... 1936Bentonite.................................................................................. 1938Benzalkonium chloride.......................................................... 1938Benzalkonium chloride solution........................................... 1940Benzathine benzylpenicillin tetrahydrate ............................ 1951Benzathine penicillin G tetrahydrate ................................... 1951Benzathine penicillin V tetrahydrate ................................... 3531Benzathine phenoxymethylpenicillin tetrahydrate ............ 3531Benzbromarone....................................................................... 1942Benzenesulfonate (methyl, ethyl and isopropyl) in activesubstances (2.5.41.)................................................................. 186

Benzethonium chloride ......................................................... 1943Benzocaine............................................................................... 1944Benzoic acid ............................................................................ 1945Benzoin, Siam ......................................................................... 1341Benzoin, Sumatra.................................................................... 1341Benzoin tincture, Siam........................................................... 1342Benzoin tincture, Sumatra..................................................... 1343Benzoyl peroxide, hydrous .................................................... 1946Benzydamine hydrochloride ................................................. 1947Benzyl alcohol ......................................................................... 1949Benzyl benzoate ...................................................................... 1950Benzylpenicillin (benzathine) tetrahydrate ......................... 1951Benzylpenicillin potassium ................................................... 1953Benzylpenicillin (procaine) monohydrate........................... 1955Benzylpenicillin sodium ........................................................ 1957



Betacarotene ............................................................................ 1959Betacyclodextrin ..................................................................... 1960Betacyclodextrin, poly(hydroxypropyl) ether ..................... 2901Betacyclodextrin, sodium 4-sulfonatobutyl ether .............. 3935Betadex..................................................................................... 1960Betahistine dihydrochloride.................................................. 1962Betahistine mesilate................................................................ 1963Betamethasone........................................................................ 1964Betamethasone acetate ........................................................... 1966Betamethasone dipropionate................................................. 1968Betamethasone sodium phosphate....................................... 1970Betamethasone valerate ......................................................... 1971Betaxolol hydrochloride......................................................... 1973Bezafibrate ............................................................................... 1975Bicalutamide............................................................................ 1976Bifonazole ................................................................................ 1977Bilberry fruit, dried ................................................................ 1343Bilberry fruit dry extract, fresh, refined and standardised.. 1442Bilberry fruit, fresh................................................................. 1344Biological assays (2.7.) ............................................................. 261Biological assays and tests, statistical analysis of results of(5.3.) ......................................................................................... 685

Biological indicators and related microbial preparations usedin the manufacture of sterile products (5.1.2.) ................... 622

Biological products, general texts on (5.2.) ........................... 647Biological products, terminology used in monographs on(5.2.1.) ...................................................................................... 647

Biological tests (2.6.) ................................................................ 191Biotherapeutic products for human use, live ........................ 876Biotherapeutic products (live), microbiological examination of(tests for enumeration of microbial contaminants) (2.6.36.).................................................................................................. 250

Biotherapeutic products (live), microbiological examinationof (tests for specified micro-organisms) (2.6.38.)............... 255

Biotin........................................................................................ 1979Biperiden hydrochloride........................................................ 1980Biphasic insulin injection ...................................................... 2953Biphasic isophane insulin injection...................................... 2953Birch leaf .................................................................................. 1345Bisacodyl .................................................................................. 1982Bismuth subcarbonate............................................................ 1983Bismuth subgallate.................................................................. 1984Bismuth subnitrate, heavy ..................................................... 1985Bismuth subsalicylate ............................................................. 1986Bisoprolol fumarate ................................................................ 1986Bistort rhizome ....................................................................... 1347Bitter fennel ............................................................................. 1433Bitter-fennel fruit oil .............................................................. 1348Bitter-fennel herb oil .............................................................. 1350Bitterness value (2.8.15.) .......................................................... 310Bitter-orange epicarp and mesocarp .................................... 1352Bitter-orange flower................................................................ 1353Bitter-orange-epicarp and mesocarp tincture..................... 1353Bitter-orange-flower oil.......................................................... 1550Black cohosh............................................................................ 1355Black horehound..................................................................... 1358Blackcurrant leaf ..................................................................... 1359Bleomycin sulfate.................................................................... 1989Blood and blood components, human, empty sterile containersof plasticised poly(vinyl chloride) for (3.3.5.)..................... 473

Blood and blood components, human, materials basedon plasticised poly(vinyl chloride) for containers for(3.3.2.) ...................................................................................... 465

Blood and blood components, human, materials for containersfor (3.3.1.) ................................................................................ 465

Blood and blood components, human, sterile plasticcontainers for (3.3.4.) ............................................................. 471

Blood and blood components, materials based on plasticisedpoly(vinyl chloride) for tubing used in sets for the transfusionof (3.3.3.).................................................................................. 468

Blood and blood components, sets for the transfusion of(3.3.7.) ...................................................................................... 475

Blood containing anticoagulant solution, human, sterilecontainers of plasticised poly(vinyl chloride) for (3.3.6.).. 474

Blood, human anticoagulant and preservative solutionsfor ........................................................................................... 1856

Bogbean leaf ............................................................................ 1360Boiling point (2.2.12.) ................................................................ 31Boldine ..................................................................................... 1990Boldo leaf ................................................................................. 1361Boldo leaf dry extract............................................................. 1363Borage (starflower) oil, refined ............................................. 1992Borax ........................................................................................ 1992Bordetella bronchiseptica vaccine (live) for dogs............... 1070Boric acid................................................................................. 1993Botulinum antitoxin ............................................................... 1169Botulinum toxin type A for injection .................................. 1993Botulinum toxin type B for injection................................... 1995Bovine insulin ......................................................................... 2946Bovine leptospirosis vaccine (inactivated) .......................... 1071Bovine parainfluenza virus vaccine (live)............................ 1073Bovine respiratory syncytial virus vaccine (live) ................ 1074Bovine rhinotracheitis vaccine (inactivated), infectious ... 1120Bovine rhinotracheitis vaccine (live), infectious ................ 1121Bovine serum .......................................................................... 1996Bovine tuberculin purified protein derivative..................... 4120Bovine viral diarrhoea vaccine (inactivated) ...................... 1075Brimonidine tartrate .............................................................. 1998Bromazepam ........................................................................... 1999Bromhexine hydrochloride.................................................... 2000Bromocriptine mesilate.......................................................... 2001Bromperidol ............................................................................ 2003Bromperidol decanoate.......................................................... 2005Brompheniramine maleate .................................................... 2007Bronchitis vaccine (inactivated), infectious, avian ............. 1059Bronchitis vaccine (live), infectious, avian .......................... 1060Brotizolam ............................................................................... 2008Brucellosis vaccine (live) (Brucella melitensis Rev. 1 strain) forveterinary use........................................................................ 1076

Buccal tablets and sublingual tablets...................................... 922Buckwheat herb ...................................................................... 1364Budesonide .............................................................................. 2009Bufexamac ............................................................................... 2011Buffer solutions (4.1.3.)............................................................ 602Buflomedil hydrochloride...................................................... 2012Bulk density and tapped density of powders (2.9.34.) ......... 384Bumetanide ............................................................................. 2014Bupivacaine hydrochloride.................................................... 2015Bupleurum root ...................................................................... 1365Buprenorphine ........................................................................ 2017Buprenorphine hydrochloride .............................................. 2019Bursal disease vaccine (inactivated), infectious, avian....... 1062Bursal disease vaccine (live), infectious, avian.................... 1063Buserelin .................................................................................. 2020Buspirone hydrochloride ....................................................... 2022Busulfan ................................................................................... 2024Butcher’s broom...................................................................... 1367Butyl parahydroxybenzoate................................................... 2025Butylated methacrylate copolymer, basic ............................ 1925Butylhydroxyanisole ............................................................... 2026Butylhydroxytoluene .............................................................. 2027

CCabergoline ............................................................................. 2031Cachets....................................................................................... 907Cadmium sulfate hydrate for homoeopathic prepara-tions........................................................................................ 1707

Cadmium sulfuricum for homoeopathic preparations...... 1707Caffeine .................................................................................... 2032Caffeine monohydrate............................................................ 2033Calcifediol monohydrate ....................................................... 2035Calcipotriol.............................................................................. 2036Calcipotriol monohydrate ..................................................... 2038Calcitonin (salmon)................................................................ 2040



Calcitriol .................................................................................. 2043Calcium (2.4.3.)......................................................................... 138Calcium acetate....................................................................... 2044Calcium ascorbate .................................................................. 2045Calcium carbonate.................................................................. 2046Calcium carboxymethylcellulose .......................................... 2093Calcium chloride dihydrate................................................... 2047Calcium chloride hexahydrate .............................................. 2047Calcium dobesilate monohydrate ......................................... 2048Calcium edetate, sodium ....................................................... 3807Calcium fluoratum for homoeopathic preparations .......... 1707Calcium folinate hydrate........................................................ 2049Calcium glucoheptonate ........................................................ 2051Calcium gluconate .................................................................. 2052Calcium gluconate, anhydrous.............................................. 2052Calcium gluconate for injection ........................................... 2053Calcium glycerophosphate .................................................... 2054Calcium hydrogen phosphate ............................................... 2055Calcium hydrogen phosphate dihydrate.............................. 2056Calcium hydroxide ................................................................. 2057Calcium in adsorbed vaccines (2.5.14.) ................................. 172Calcium iodatum for homoeopathic preparations ............. 1708Calcium iodide tetrahydrate for homoeopathicpreparations .......................................................................... 1708

Calcium lactate........................................................................ 2058Calcium lactate monohydrate ............................................... 2058Calcium lactate pentahydrate................................................ 2059Calcium lactate trihydrate ..................................................... 2059Calcium levofolinate hydrate ................................................ 2060Calcium levulinate dihydrate ................................................ 2062Calcium pantothenate ............................................................ 2063Calcium pentetate (sodium) for radiopharmaceuticalpreparations .......................................................................... 1223

Calcium phosphate ................................................................. 2065Calcium stearate ..................................................................... 2065Calcium sulfate dihydrate...................................................... 2067Calendula flower..................................................................... 1368Calf coronavirus diarrhoea vaccine (inactivated)............... 1077Calf rotavirus diarrhoea vaccine (inactivated).................... 1078Calicivirosis vaccine (inactivated), feline ............................ 1106Calicivirosis vaccine (live), feline ......................................... 1107Camphor, D-............................................................................ 2067Camphor, racemic .................................................................. 2069Candesartan cilexetil .............................................................. 2070Canine adenovirus vaccine (inactivated)............................. 1079Canine adenovirus vaccine (live).......................................... 1080Canine distemper vaccine (live) ........................................... 1081Canine leptospirosis vaccine (inactivated) .......................... 1082Canine parainfluenza virus vaccine (live) ........................... 1084Canine parvovirosis vaccine (inactivated)........................... 1085Canine parvovirosis vaccine (live)........................................ 1086Cape aloes................................................................................ 1302Cape jasmine fruit .................................................................. 1369Capecitabine............................................................................ 2072Capillary electrophoresis (2.2.47.) ............................................ 87Capillary viscometer method (2.2.9.)....................................... 27Caprylate, sodium................................................................... 3808Caprylic acid ........................................................................... 2073Caprylocaproyl macrogolglycerides ..................................... 2074Capsicum ................................................................................. 1371Capsicum oleoresin, refined and standardised ................... 1373Capsicum soft extract, standardised .................................... 1374Capsicum tincture, standardised .......................................... 1375Capsules ..................................................................................... 906Capsules and tablets, disintegration of (2.9.1.) ..................... 323Capsules, gastro-resistant ........................................................ 907Capsules, hard ........................................................................... 906Capsules, intrauterine .............................................................. 914Capsules, modified-release ...................................................... 907Capsules, oromucosal............................................................... 922Capsules, rectal ......................................................................... 934Capsules, soft............................................................................. 906Capsules, vaginal....................................................................... 941

Captopril .................................................................................. 2075Caraway fruit........................................................................... 1376Caraway oil .............................................................................. 1377Carbachol................................................................................. 2078Carbamazepine ....................................................................... 2078Carbasalate calcium................................................................ 2080Carbidopa ................................................................................ 2081Carbimazole ............................................................................ 2083Carbocisteine........................................................................... 2084Carbomers ............................................................................... 2085Carbon dioxide ....................................................................... 2086Carbon dioxide in gases (2.5.24.) ........................................... 174Carbon monoxide................................................................... 2088Carbon monoxide (15O) ......................................................... 1184Carbon monoxide in gases (2.5.25.)....................................... 175Carbon monoxide intermix (5 per cent) in nitrogen ......... 2089Carboplatin.............................................................................. 2089Carboprost trometamol ......................................................... 2090Carboxymethylcellulose......................................................... 2092Carboxymethylcellulose calcium.......................................... 2093Carboxymethylcellulose sodium........................................... 2093Carboxymethylcellulose sodium, cross-linked ................... 2318Carboxymethylcellulose sodium, low-substituted....

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