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Home , Alcuronium chloride, Alfacalcidol, Alovudine, Alprenolol, Aluminium phosphate, Aluminium triacetate

EUROPEAN PHARMACOPOEIA 10.0 Index

1. General notices...... 3 2.2.66. Detection and measurement of radioactivity...... 119 2.1. Apparatus ...... 15 2.2.7. ...... 26 2.1.1. Droppers ...... 15 2.2.8. Viscosity ...... 27 2.1.2. Comparative table of porosity of sintered-glass filters.. 15 2.2.9. Capillary viscometer method ...... 27 2.1.3. Ultraviolet ray lamps for analytical purposes...... 15 2.3. Identification...... 129 2.1.4. Sieves ...... 16 2.3.1. Identification reactions of and functional 2.1.5. Tubes for comparative tests ...... 17 groups ...... 129 2.1.6. detector tubes...... 17 2.3.2. Identification of fatty by thin-layer 2.2. Physical and physico-chemical methods...... 21 chromatography...... 132 2.2.1. Clarity and degree of opalescence of liquids ...... 21 2.3.3. Identification of by thin-layer 2.2.10. Viscosity - Rotating viscometer method...... 28 chromatography...... 133 2.2.11. Distillation range ...... 30 2.3.4. Odour ...... 133 2.2.12. Boiling point...... 31 2.4. Limit tests...... 137 2.2.13. Determination of by distillation...... 31 2.4.1. Ammonium ...... 137 2.2.14. - capillary method...... 32 2.4.10. in ...... 142 2.2.15. Melting point - open capillary method...... 33 2.4.11. Phosphates ...... 142 2.2.16. Melting point - instantaneous method...... 33 2.4.12. ...... 142 2.2.17. Drop point ...... 33 2.4.13. ...... 142 2.2.18. Freezing point...... 35 2.4.14. Sulfated ash...... 142 2.2.19. Amperometric titration...... 35 2.4.15. in polyols...... 143 2.2.2. Degree of coloration of liquids...... 22 2.4.16. Total ash ...... 143 2.2.20. Potentiometric titration ...... 35 2.4.17. ...... 143 2.2.21. Fluorimetry...... 36 2.4.18. Free formaldehyde ...... 143 2.2.22. Atomic emission spectrometry ...... 36 2.4.19. Alkaline impurities in fatty oils...... 144 2.2.23. Atomic absorption spectrometry...... 37 2.4.2. ...... 137 2.2.24. Absorption spectrophotometry, infrared...... 39 2.4.20. Determination of elemental impurities...... 144 2.2.25. Absorption spectrophotometry, ultraviolet and 2.4.21. Foreign oils in fatty oils by thin-layer visible ...... 42 chromatography...... 147 2.2.26. Paper chromatography ...... 46 2.4.22. Composition of fatty by gas chromatography.. 147 2.2.27. Thin-layer chromatography...... 47 2.4.23. Sterols in fatty oils...... 150 2.2.28. Gas chromatography...... 48 2.4.24. Identification and control of residual solvents...... 152 2.2.29. Liquid chromatography...... 49 2.4.25. oxide and dioxan...... 157 2.2.3. Potentiometric determination of pH...... 24 2.4.26. N,N-Dimethylaniline...... 158 2.2.30. Size-exclusion chromatography ...... 51 2.4.27. in herbal and herbal 2.2.31. Electrophoresis...... 51 preparations ...... 158 2.2.32. Loss on drying...... 57 2.4.28. 2-Ethylhexanoic ...... 160 2.2.33. Nuclear magnetic resonance spectrometry ...... 58 2.4.29. Composition of fatty acids in oils rich in omega-3 2.2.34. Thermal analysis ...... 61 acids...... 161 2.2.35. Osmolality...... 63 2.4.3. ...... 138 2.2.36. Potentiometric determination of ionic 2.4.30. and diethylene glycol in ethoxylated concentration using -selective electrodes ...... 64 substances...... 163 2.2.37. X-ray fluorescence spectrometry ...... 65 2.4.31. Nickel in hydrogenated vegetable oils ...... 163 2.2.38. Conductivity...... 66 2.4.32. Total in oils rich in omega-3 acids...... 163 2.2.39. Molecular mass distribution in ...... 68 2.4.4. Chlorides...... 138 2.2.4. Approximate pH of ...... 25 2.4.5. Fluorides...... 138 2.2.40. Near- ...... 70 2.4.6. ...... 138 2.2.41. Circular dichroism...... 75 2.4.7. Magnesium and alkaline-earth metals ...... 139 2.2.42. of solids...... 76 2.4.8. Heavy metals...... 139 2.2.43. ...... 77 2.4.9. ...... 142 2.2.44. Total organic in water for pharmaceutical 2,4-Dichlorobenzyl ...... 2390 use...... 79 2.5. Assays ...... 167 2.2.45. Supercritical fluid chromatography...... 80 2.5.1. Acid value...... 167 2.2.46. Chromatographic separation techniques...... 80 2.5.10. -flask method ...... 170 2.2.47. Capillary electrophoresis...... 87 2.5.11. Complexometric titrations...... 170 2.2.48. Raman spectroscopy...... 92 2.5.12. Water: semi-micro determination ...... 171 2.2.49. Falling ball and automatic rolling ball viscometer 2.5.13. Aluminium in adsorbed vaccines ...... 171 methods ...... 94 2.5.14. Calcium in adsorbed vaccines...... 172 2.2.5. Relative density...... 25 2.5.15. in immunosera and vaccines...... 172 2.2.54. Isoelectric focusing ...... 95 2.5.16. Protein in polysaccharide vaccines...... 172 2.2.55. Peptide mapping ...... 97 2.5.17. Nucleic acids in polysaccharide vaccines...... 172 2.2.56. analysis...... 100 2.5.18. in polysaccharide vaccines ...... 172 2.2.57. Inductively coupled plasma-atomic emission 2.5.19. O-Acetyl in polysaccharide vaccines ...... 173 spectrometry ...... 106 2.5.2. value...... 167 2.2.58. Inductively coupled plasma-mass spectrometry...... 108 2.5.20. Hexosamines in polysaccharide vaccines...... 173 2.2.59. Glycan analysis of glycoproteins ...... 109 2.5.21. Methylpentoses in polysaccharide vaccines...... 173 2.2.6. ...... 26 2.5.22. Uronic acids in polysaccharide vaccines...... 174 2.2.61. Characterisation of crystalline solids by 2.5.23. Sialic acid in polysaccharide vaccines ...... 174 microcalorimetry and calorimetry...... 115 2.5.24. in ...... 174 2.2.63. Direct amperometric and pulsed electrochemical 2.5.25. in gases ...... 175 detection ...... 117 2.5.26. monoxide and nitrogen dioxide in gases.. 176 2.2.64. Peptide identification by nuclear magnetic resonance 2.5.27. Oxygen in gases...... 176 spectrometry ...... 118 2.5.28. Water in gases...... 176 2.2.65. Voltametric titration...... 119 2.5.29. dioxide ...... 177

General Notices (1) apply to all monographs and other texts 4259 Index EUROPEAN PHARMACOPOEIA 10.0

2.5.3. Hydroxyl value ...... 167 2.7.13. Assay of human anti-D immunoglobulin...... 282 2.5.30. Oxidising substances ...... 177 2.7.14. Assay of A vaccine ...... 284 2.5.31. in polysaccharide vaccines...... 177 2.7.15. Assay of vaccine (rDNA)...... 285 2.5.32. Water: micro determination...... 178 2.7.16. Assay of pertussis vaccine (acellular) ...... 286 2.5.33. Total protein ...... 178 2.7.17. Assay of human III ...... 288 2.5.34. in synthetic peptides...... 181 2.7.18. Assay of human factor II ...... 288 2.5.35. in gases ...... 182 2.7.19. Assay of human coagulation ...... 289 2.5.36. Anisidine value...... 182 2.7.2. Microbiological assay of ...... 262 2.5.37. Methyl, ethyl and isopropyl methanesulfonate in 2.7.20. assay of poliomyelitis vaccine (inactivated).. 289 methanesulfonic acid ...... 182 2.7.21. Assay of human von Willebrand factor...... 290 2.5.38. Methyl, ethyl and isopropyl methanesulfonate in active 2.7.22. Assay of human coagulation factor XI...... 291 substances...... 183 2.7.23. Numeration of CD34/CD45+ cells in haematopoietic 2.5.39. Methanesulfonyl chloride in methanesulfonic products...... 292 acid ...... 184 2.7.24. Flow cytometry ...... 293 2.5.4. value ...... 167 2.7.25. Assay of human plasmin inhibitor...... 295 2.5.40. Methyl, ethyl and isopropyl toluenesulfonate in active 2.7.27. Flocculation value (Lf) of diphtheria and tetanus toxins substances...... 185 and toxoids (Ramon assay) ...... 295 2.5.41. Methyl, ethyl and isopropyl benzenesulfonate in active 2.7.28. Colony-forming assay for human substances...... 186 haematopoietic progenitor cells...... 296 2.5.5. value...... 168 2.7.29. Nucleated cell count and viability...... 297 2.5.6. Saponification value...... 169 2.7.30. Assay of human ...... 299 2.5.7. Unsaponifiable matter ...... 169 2.7.31. Assay of human protein S ...... 300 2.5.8. Determination of primary aromatic amino- 2.7.32. Assay of human α-1-proteinase inhibitor ...... 300 nitrogen...... 169 2.7.34. Assay of human C1-esterase inhibitor ...... 301 2.5.9. Determination of nitrogen by 2.7.35. Immunonephelometry for vaccine component ...... 170 assay ...... 301 2.6. Biological tests...... 191 2.7.4. Assay of human coagulation factor VIII...... 268 2.6.1. Sterility ...... 191 2.7.5. Assay of ...... 269 2.6.10. ...... 200 2.7.6. Assay of diphtheria vaccine (adsorbed) ...... 269 2.6.11. Depressor substances...... 200 2.7.7. Assay of pertussis vaccine (whole cell)...... 274 2.6.12. Microbiological examination of non-sterile products: 2.7.8. Assay of tetanus vaccine (adsorbed)...... 275 microbial enumeration tests...... 201 2.7.9. Test for Fc function of immunoglobulin...... 279 2.6.13. Microbiological examination of non-sterile products: 2.8. Methods in pharmacognosy ...... 305 test for specified micro-organisms ...... 205 2.8.1. Ash insoluble in ...... 305 2.6.14. Bacterial endotoxins ...... 209 2.8.10. in alcohol of essential oils...... 306 2.6.15. Prekallikrein activator ...... 213 2.8.11. Assay of 1,8-cineole in essential oils...... 307 2.6.16. Tests for extraneous agents in viral vaccines for human 2.8.12. Essential oils in herbal drugs...... 307 use...... 214 2.8.13. residues ...... 308 2.6.17. Test for anticomplementary activity of 2.8.14. Tannins in herbal drugs ...... 310 immunoglobulin...... 216 2.8.15. Bitterness value...... 310 2.6.18. Test for neurovirulence of live virus vaccines ...... 218 2.8.16. Dry residue of extracts ...... 311 2.6.2. Mycobacteria ...... 194 2.8.17. Loss on drying of extracts...... 311 2.6.20. Anti-A and anti-B haemagglutinins ...... 218 2.8.18. Determination of aflatoxin B1 in herbal drugs...... 311 2.6.21. Nucleic acid amplification techniques...... 219 2.8.2. Foreign matter ...... 305 2.6.22. Activated coagulation factors ...... 224 2.8.20. Herbal drugs: sampling and sample preparation .... 313 2.6.24. Avian viral vaccines: tests for extraneous agents in 2.8.21. Test for aristolochic acids in herbal drugs...... 314 seed lots ...... 224 2.8.22. Determination of ochratoxin A in herbal drugs...... 316 2.6.25. Avian live virus vaccines: tests for extraneous agents in 2.8.23. Microscopic examination of herbal drugs ...... 317 batches of finished product ...... 227 2.8.24. Foam index ...... 317 2.6.26. Test for anti-D antibodies in human immunoglobu- 2.8.25. High-performance thin-layer chromatography of lin...... 230 herbal drugs and herbal drug preparations ...... 318 2.6.27. Microbiological examination of cell-based 2.8.3. Stomata and stomatal index...... 305 preparations ...... 231 2.8.4. Swelling index...... 306 2.6.30. Monocyte-activation test...... 233 2.8.5. Water in essential oils...... 306 2.6.31. Microbiological examination of herbal medicinal 2.8.6. Foreign in essential oils ...... 306 products for oral use and extracts used in their 2.8.7. Fatty oils and resinified essential oils in essential preparation ...... 239 oils ...... 306 2.6.33. Residual pertussis toxin...... 241 2.8.8. Odour and of essential oils ...... 306 2.6.34. Host-cell protein assays...... 244 2.8.9. Residue on evaporation of essential oils ...... 306 2.6.35. Quantification and characterisation of residual 2.9. Pharmaceutical technical procedures...... 323 host-cell DNA ...... 248 2.9.1. Disintegration of tablets and capsules...... 323 2.6.36. Microbiological examination of live biotherapeutic 2.9.10. content ...... 339 products: tests for enumeration of microbial 2.9.11. Test for and 2-propanol ...... 342 contaminants...... 250 2.9.12. Sieve test...... 343 2.6.38. Microbiological examination of live biotherapeutic 2.9.14. Specific surface area by air permeability...... 343 products: tests for specified micro-organisms...... 255 2.9.16. Flowability...... 346 2.6.7. Mycoplasmas ...... 194 2.9.17. Test for extractable volume of parenteral 2.6.8. Pyrogens...... 199 preparations ...... 347 2.7. Biological assays ...... 261 2.9.18. Preparations for inhalation: aerodynamic assessment 2.7.1. Immunochemical methods...... 261 of fine particles...... 347 2.7.10. Assay of human coagulation factor VII ...... 280 2.9.19. Particulate contamination: sub-visible particles...... 360 2.7.11. Assay of human coagulation factor IX...... 281 2.9.2. Disintegration of suppositories and pessaries ...... 325 2.7.12. Assay of heparin in coagulation factors ...... 281 2.9.20. Particulate contamination: visible particles ...... 362

4260 See the information section on general monographs (cover pages) EUROPEAN PHARMACOPOEIA 10.0 Index

2.9.22. Softening time determination of lipophilic 3.2.2.1. Plastic containers for aqueous solutions for suppositories ...... 363 infusion...... 460 2.9.23. Gas pycnometric density of solids ...... 364 3.2.3. Sterile plastic containers for human and 2.9.25. Dissolution test for medicated chewing gums ...... 365 blood components (see 3.3.4.) ...... 471 2.9.26. Specific surface area by gas adsorption...... 369 3.2.4. Empty sterile containers of plasticised poly(vinyl 2.9.27. Uniformity of mass of delivered doses from multidose chloride) for human blood and blood components (see containers ...... 372 3.3.5.)...... 473 2.9.29. Intrinsic dissolution...... 372 3.2.5. Sterile containers of plasticised poly(vinyl chloride) 2.9.3. Dissolution test for solid dosage forms...... 326 for human blood containing solution (see 2.9.31. Particle size analysis by laser light diffraction...... 373 3.3.6.)...... 474 2.9.32. Porosity and pore-size distribution of solids by 3.2.6. Sets for the transfusion of blood and blood components porosimetry ...... 377 (see 3.3.7.)...... 475 2.9.33. Characterisation of crystalline and partially crystalline 3.2.8. Sterile single-use plastic syringes (see 3.3.8.) ...... 477 solids by X-ray powder diffraction (XRPD) ...... 379 3.2.9. Rubber closures for containers for aqueous 2.9.34. Bulk density and tapped density of powders...... 384 parenteral preparations, for powders and for 2.9.35. Powder fineness...... 387 freeze-dried powders...... 460 2.9.36. Powder flow ...... 387 3.3. Containers for human blood and blood components, and 2.9.37. Optical microscopy...... 390 materials used in their manufacture; transfusion sets and 2.9.38. Particle-size distribution estimation by analytical materials used in their manufacture; syringes...... 463 sieving ...... 392 3.3.1. Materials for containers for human blood and blood 2.9.39. Water-solid interactions: determination of components...... 465 sorption-desorption isotherms and of water activity...... 394 3.3.2. Materials based on plasticised poly(vinyl chloride) for 2.9.4. Dissolution test for transdermal patches ...... 333 containers for human blood and blood components...... 465 2.9.40. Uniformity of dosage units...... 398 3.3.3. Materials based on plasticised poly(vinyl chloride) for 2.9.41. Friability of granules and spheroids ...... 400 tubing used in sets for the transfusion of blood and blood 2.9.42. Dissolution test for lipophilic solid dosage forms ... 401 components...... 468 2.9.43. Apparent dissolution ...... 403 3.3.4. Sterile plastic containers for human blood and 2.9.44. Preparations for nebulisation: characterisation...... 404 blood components...... 471 2.9.45. Wettability of porous solids including powders...... 406 3.3.5. Empty sterile containers of plasticised poly(vinyl 2.9.47. Demonstration of uniformity of dosage units using chloride) for human blood and blood components...... 473 large sample sizes...... 409 3.3.6. Sterile containers of plasticised poly(vinyl chloride) for 2.9.49. Powder flow properties by shear cell methods...... 411 human blood containing anticoagulant solution ...... 474 2.9.5. Uniformity of mass of single-dose preparations...... 335 3.3.7. Sets for the transfusion of blood and blood 2.9.52. Scanning electron microscopy ...... 414 components...... 475 2.9.6. Uniformity of content of single-dose preparations.... 336 3.3.8. Sterile single-use plastic syringes ...... 477 2.9.7. Friability of uncoated tablets ...... 336 3-O-Desacyl-4′-monophosphoryl lipid A...... 2355 2.9.8. Resistance to crushing of tablets ...... 337 4. Reagents...... 481 2.9.9. Measurement of consistency by penetrometry ...... 337 4.1. Reagents, standard solutions, buffer solutions...... 481 3.1. Materials used for the manufacture of containers ...... 423 4.1.1. Reagents ...... 481 3.1.1. Materials for containers for human blood and blood 4.1.2. Standard solutions for limit tests ...... 598 components (see 3.3.1.) ...... 465 4.1.3. Buffer solutions ...... 602 3.1.10. Materials based on non-plasticised poly(vinyl chloride) 4.2. Volumetric analysis...... 609 for containers for non-injectable, aqueous solutions...... 437 4.2.1. Primary standards for volumetric solutions...... 609 3.1.11. Materials based on non-plasticised poly(vinyl 4.2.2. Volumetric solutions...... 609 chloride) for containers for solid dosage forms for oral 4-Aminobenzoic acid ...... 1819 administration...... 439 5.1. General texts on microbiology ...... 619 3.1.1.1. Materials based on plasticised poly(vinyl chloride) 5.10. Control of impurities in substances for pharmaceutical for containers for human blood and blood components (see use...... 763 3.3.2.)...... 465 5.11. Characters section in monographs ...... 769 3.1.1.2. Materials based on plasticised poly(vinyl chloride) for 5.1.1. Methods of preparation of sterile products ...... 619 tubing used in sets for the transfusion of blood and blood 5.1.10. Guidelines for using the test for bacterial components (see 3.3.3.) ...... 468 endotoxins ...... 639 3.1.13. Plastic additives...... 441 5.1.11. Determination of bactericidal, fungicidal or yeasticidal 3.1.14. Materials based on plasticised poly(vinyl chloride) activity of medicinal products...... 643 for containers for aqueous solutions for intravenous 5.1.2. Biological indicators and related microbial preparations infusion...... 445 used in the manufacture of sterile products...... 622 3.1.15. Polyethylene terephthalate for containers for 5.12. Reference standards...... 773 preparations not for parenteral use...... 448 5.1.3. Efficacy of antimicrobial preservation ...... 625 3.1.3. Polyolefins...... 423 5.14. Gene transfer medicinal products for human use ...... 779 3.1.4. Polyethylene without additives for containers for 5.1.4. Microbiological quality of non-sterile pharmaceutical parenteral preparations and for ophthalmic preparations.. 426 preparations and substances for pharmaceutical use...... 627 3.1.5. Polyethylene with additives for containers for parenteral 5.1.5. Application of the F0 concept to steam sterilisation of preparations and for ophthalmic preparations...... 427 aqueous preparations ...... 628 3.1.6. for containers and closures for parenteral 5.15. Functionality-related characteristics of ...... 793 preparations and ophthalmic preparations...... 431 5.1.6. Alternative methods for control of microbiological 3.1.7. Poly(ethylene - vinyl ) for containers and tubing quality ...... 628 for total parenteral nutrition preparations...... 434 5.16. Crystallinity ...... 797 3.1.8. Silicone used as a ...... 436 5.17. Recommendations on methods for dosage forms 3.1.9. Silicone elastomer for closures and tubing ...... 436 testing...... 801 3.2. Containers...... 453 5.1.7. Viral safety ...... 637 3.2.1. Glass containers for pharmaceutical use...... 453 5.17.1. Recommendations on dissolution testing...... 801 3.2.2. Plastic containers and closures for pharmaceutical 5.1.8. Microbiological quality of herbal medicinal products for use...... 459 oral use and extracts used in their preparation ...... 638

General Notices (1) apply to all monographs and other texts 4261 Index EUROPEAN PHARMACOPOEIA 10.0

5.19. Extemporaneous preparation of radiopharmaceuti- β-Acetyldigoxin...... 1750 cals...... 807 Acetylene intermix (1 per cent) in nitrogen...... 1752 5.1.9. Guidelines for using the test for sterility...... 639 Acetylsalicylic acid ...... 1753 5.2. General texts on biological products...... 647 Acetyltryptophan, N- ...... 1755 5.20. Elemental impurities ...... 815 Acetyltyrosine, N-...... 1757 5.21. Chemometric methods applied to analytical data ...... 819 Achyranthes bidentata root ...... 1293 5.2.1. Terminology used in monographs on biological ...... 1758 products...... 647 Acid value (2.5.1.)...... 167 5.2.11. Carrier proteins for the production of conjugated Acidum picrinicum for homoeopathic preparations ...... 1698 polysaccharide vaccines for human use...... 674 Acidum succinicum for homoeopathic preparations ...... 1698 5.2.12. Raw materials of biological origin for the production ...... 1760 of cell-based and gene therapy medicinal products...... 675 Actinobacillosis vaccine (inactivated), porcine ...... 1139 5.2.13. Healthy chicken flocks for the production of inactivated Activated charcoal ...... 2162 vaccines for veterinary use ...... 679 Activated coagulation factors (2.6.22.)...... 224 5.2.14. Substitution of in vivo method(s) by method(s) ...... 1761 for the quality control of vaccines ...... 679 Additives, plastic (3.1.13.) ...... 441 5.2.2. Chicken flocks free from specified pathogens for the ...... 1762 production and quality control of vaccines...... 647 ...... 1763 5.22. Names of herbal drugs used in traditional Chinese Adenovirus vaccine (inactivated), canine...... 1079 ...... 839 Adenovirus vaccine (live), canine...... 1080 5.2.3. Cell substrates for the production of vaccines for human Adipic acid...... 1765 use...... 650 ...... 1766 5.23. Monographs on herbal drug extracts (information Adrenaline tartrate ...... 1767 chapter)...... 843 Adsorption, gas, specific surface area by (2.9.26.)...... 369 5.2.4. Cell cultures for the production of veterinary Aerodynamic assessment of fine particles in preparations for vaccines...... 654 inhalation (2.9.18.) ...... 347 5.24. Chemical imaging...... 847 Aflatoxin B1 in herbal drugs, determination of (2.8.18.) ..... 311 5.25. Process analytical technology...... 855 Agar ...... 1295 5.2.5. Substances of animal origin for the production of Agaricus phalloides for homoeopathic preparations ...... 1699 immunological veterinary medicinal products ...... 656 Agnus castus fruit...... 1295 5.2.6. Evaluation of safety of veterinary vaccines and Agnus castus fruit dry extract...... 1296 immunosera ...... 658 Agrimony...... 1297 5.2.7. Evaluation of efficacy of veterinary vaccines and Air, medicinal ...... 1768 immunosera ...... 661 Air, synthetic medicinal...... 1770 5.2.8. Minimising the risk of transmitting animal spongiform Akebia stem...... 1298 encephalopathy agents via human and veterinary medicinal ...... 1771 products...... 661 ...... 1773 5.2.9. Evaluation of safety of each batch of immunosera for Albumin solution, human ...... 2832 veterinary use...... 673 Alchemilla...... 1300 5.3. Statistical analysis of results of biological assays and Alcoholimetric tables (5.5.) ...... 727 tests...... 685 ...... 1774 5.4. Residual solvents ...... 717 Alendronate trihydrate, ...... 3798 5.5. Alcoholimetric tables...... 727 Alexandrian pods ...... 1622 5.6. Assay of ...... 741 Alfacalcidol...... 1776 5.7.Tableofphysicalcharacteristicsofradionuclides Alfadex...... 1777 mentioned in the European Pharmacopoeia ...... 745 hydrochloride hydrate ...... 1778 5.8. Pharmacopoeial harmonisation ...... 755 hydrochloride...... 1780 5.9. Polymorphism ...... 759 Alginate, sodium...... 3799 Alginic acid...... 1781 A hemitartrate...... 1782 ...... 1733 Alkaline impurities in fatty oils (2.4.19.)...... 144 Abbreviations and symbols (1.) ...... 3 Alkaline-earth metals and magnesium (2.4.7.)...... 139 Abelmoschi corolla...... 1289 Allantoin ...... 1783 Absorption spectrophotometry, infrared (2.2.24.)...... 39 Allergen products ...... 861 Absorption spectrophotometry, ultraviolet and visible Allergen products, animal epithelia and outgrowths for... 1854 (2.2.25.) ...... 42 Allergen products, Hymenoptera venoms for...... 2908 Acacia...... 1290 Allergen products, for...... 3281 Acacia, dried dispersion...... 1734 Allergen products, moulds for ...... 3302 calcium ...... 1736 Allergen products, pollens for...... 3583 Acanthopanax bark ...... 1292 Allium sativum for homoeopathic preparations ...... 1701 Acarbose ...... 1736 ...... 1784 hydrochloride...... 1738 all-rac-α-...... 4057 ...... 1740 all-rac-α-Tocopheryl acetate...... 4059 ...... 1742 ...... 1786 ...... 1744 Almond oil, refined ...... 1787 Acetate trihydrate, sodium ...... 3797 Almond oil, virgin ...... 1787 ...... 1745 Aloes, Barbados ...... 1301 Acetic acid, glacial ...... 1746 Aloes, Cape...... 1302 Aloes dry extract, standardised...... 1303 Acetic acid in synthetic peptides (2.5.34.)...... 181 18 ...... 1747 ( F) injection ...... 1181 chloride ...... 1748 Alphacyclodextrin ...... 1777 ...... 1749 ...... 1788 hydrochloride ...... 1790

4262 See the information section on general monographs (cover pages) EUROPEAN PHARMACOPOEIA 10.0 Index

Alprostadil...... 1791 Angelica archangelica root ...... 1309 for injection...... 1793 Angelica dahurica root...... 1310 Alternative methods for control of microbiological quality Angelica pubescens root ...... 1312 (5.1.6.) ...... 628 root ...... 1314 Altizide...... 1797 Animal anti-T lymphocyte immunoglobulin for human ...... 1798 use...... 1858 Aluminium (2.4.17.)...... 143 Animal epithelia and outgrowths for allergen products.... 1854 hexahydrate...... 1798 Animal immunosera for human use ...... 871 , hydrated, for adsorption ...... 1798 Animal spongiform encephalopathies, products with risk of Aluminium in adsorbed vaccines (2.5.13.)...... 171 transmitting agents of ...... 884 Aluminium magnesium silicate...... 1799 Animal spongiform encephalopathy agents, minimising the , hydrated ...... 1801 risk of transmitting via human and veterinary medicinal gel ...... 1802 products (5.2.8.)...... 661 Aluminium phosphate, hydrated...... 1803 Anise oil...... 1315 Aluminium ...... 1803 Aniseed ...... 1317 Aluminium stearate...... 1804 Anisidine value (2.5.36.) ...... 182 ...... 1806 hydrochloride...... 1855 Alverine citrate...... 1807 spore vaccine (live) for veterinary use...... 1055 hydrochloride ...... 1808 Anthrax vaccine for human use (adsorbed, prepared from hydrochloride ...... 1809 culture filtrates)...... 947 Amfetamine sulfate ...... 1810 Anti-A and anti-B haemagglutinins (2.6.20.)...... 218 Amidotrizoate, sodium...... 3800 Antibiotics, microbiological assay of (2.7.2.) ...... 262 Amidotrizoic acid dihydrate ...... 1812 Antibodies (anti-D) in human immunoglobulin, test for ...... 1813 (2.6.26.) ...... 230 Amikacin sulfate...... 1815 Antibodies for human use, monoclonal ...... 878 hydrochloride dihydrate ...... 1818 Anticoagulant and solutions for human blood Amino acid analysis (2.2.56.) ...... 100 ...... 1856 Aminobenzoic acid, 4-...... 1819 Anticomplementary activity of immunoglobulin (2.6.17.).. 216 ...... 1821 Anti-D antibodies in human immunoglobulin, test for ...... 1821 (2.6.26.) ...... 230 ...... 4008 Anti-D immunoglobulin for intravenous administration, Aminophylline hydrate ...... 4009 human ...... 2835 Aminosalicylate dihydrate, sodium...... 3801 Anti-D immunoglobulin, human ...... 2834 hydrochloride...... 1823 Anti-D immunoglobulin, human, assay of (2.7.13.) ...... 282 ...... 1825 Antimicrobial preservation, efficacy of (5.1.3.) ...... 625 hydrochloride ...... 1826 Antiseptic medicinal products, determination of bactericidal, besilate...... 1827 fungicidal or yeasticidal activity of (5.1.11.) ...... 643 (13N) injection...... 1183 Antiserum, European viper venom...... 1174 Ammonia solution, concentrated...... 1829 Anti-T lymphocyte immunoglobulin for human use, Ammonio methacrylate copolymer (type A)...... 1830 animal ...... 1858 Ammonio methacrylate copolymer (type B) ...... 1831 Antithrombin III concentrate, human...... 2835 Ammonium (2.4.1.)...... 137 Antithrombin III, human, assay of (2.7.17.) ...... 288 Ammonium ...... 1832 Apis for homoeopathic preparations...... 1703 Ammonium carbonicum for homoeopathic prepara- hydrochloride hemihydrate ...... 1862 tions...... 1701 Apparatus (2.1.) ...... 15 ...... 1832 Apparent dissolution (2.9.43.)...... 403 Ammonium glycyrrhizate ...... 1833 Application of the F0 concept to steam sterilisation of aqueous Ammonium ...... 1834 preparations (5.1.5.) ...... 628 ...... 1834 Approximate pH of solutions (2.2.4.)...... 25 Amobarbital sodium ...... 1835 ...... 1863 Amomum fruit...... 1304 ...... 1864 Amomum fruit, round...... 1604 Aprotinin concentrated solution ...... 1867 Amorolfine hydrochloride...... 1836 Arachis oil, hydrogenated...... 1869 sodium...... 1838 Arachis oil, refined ...... 1870 Amoxicillin trihydrate...... 1840 ...... 1870 Amperometric detection, direct, and pulsed electrochemical Arginine aspartate ...... 1871 detection (2.2.63.)...... 117 Arginine hydrochloride ...... 1872 Amperometric titration (2.2.19.) ...... 35 Argon ...... 1873 ...... 1842 ...... 1874 Ampicillin...... 1844 Aristolochic acids in herbal drugs, test for (2.8.21) ...... 314 Ampicillin sodium...... 1846 Arnica flower...... 1318 Ampicillin trihydrate...... 1849 Arnica tincture...... 1320 Amylmetacresol ...... 1851 Arsenic (2.4.2.)...... 137 Anacardium for homoeopathic preparations...... 1702 Arsenicum album for homoeopathic preparations...... 1704 Anaemia vaccine (live), chicken, infectious ...... 1122 Arsenious trioxide for homoeopathic preparations ...... 1704 Anaesthetic ...... 2577 hydrochloride...... 1876 Analysis, thermal (2.2.34.)...... 61 Artichoke leaf...... 1321 Analytical sieving, particle-size distribution estimation by Artichoke leaf dry extract...... 1323 (2.9.38.) ...... 392 Ascorbate, calcium ...... 2045 Anamirta cocculus for homoeopathic preparations ...... 1708 Ascorbate, sodium...... 3802 ...... 1852 Ascorbic acid...... 1877 Andrographis herb ...... 1305 Ascorbyl palmitate...... 1879 Anemarrhena asphodeloides rhizome ...... 1307 Ash insoluble in hydrochloric acid (2.8.1.) ...... 305

General Notices (1) apply to all monographs and other texts 4263 Index EUROPEAN PHARMACOPOEIA 10.0

Ash leaf ...... 1324 Avian viral vaccines: tests for extraneous agents in seed lots Ash, sulfated (2.4.14.)...... 142 (2.6.24.) ...... 224 Ash, total (2.4.16.) ...... 143 for veterinary use ...... 1900 Asparagine monohydrate...... 1880 ...... 1901 ...... 1881 hydrochloride...... 1902 ...... 1883 ...... 1904 Assay of 1,8-cineole in essential oils (2.8.11.) ...... 307 Assay of diphtheria vaccine (adsorbed) (2.7.6.)...... 269 B Assay of heparin (2.7.5.) ...... 269 B19 virus (B19V), validation of nucleic acid amplification Assay of heparin in coagulation factors (2.7.12.) ...... 281 techniques for the quantification of B19V DNA in plasma Assay of hepatitis A vaccine (2.7.14.)...... 284 pools: guidelines...... 219 Assay of hepatitis B vaccine (rDNA) (2.7.15.) ...... 285 Bacampicillin hydrochloride...... 1911 Assay of human α-1-proteinase inhibitor (2.7.32.) ...... 300 ...... 1913 Assay of human anti-D immunoglobulin (2.7.13.) ...... 282 Bacitracin ...... 1917 Assay of human antithrombin III (2.7.17.)...... 288 ...... 1921 Assay of human C1-esterase inhibitor (2.7.34.)...... 301 Bacterial endotoxins (2.6.14.)...... 209 Assay of human coagulation factor II (2.7.18.)...... 288 Bacterial endotoxins, guidelines for using the test for Assay of human coagulation factor IX (2.7.11.) ...... 281 (5.1.10.) ...... 639 Assay of human coagulation factor VII (2.7.10.)...... 280 Bactericidal, fungicidal or yeasticidal activity of antiseptic Assay of human coagulation factor VIII (2.7.4.) ...... 268 medicinal products, determination of (5.1.11.)...... 643 Assay of human coagulation factor X (2.7.19.)...... 289 Baical skullcap root ...... 1331 Assay of human coagulation factor XI (2.7.22.) ...... 291 hydrochloride ...... 1922 Assay of human plasmin inhibitor (2.7.25.)...... 295 Barbados aloes ...... 1301 Assay of human protein C (2.7.30.)...... 299 Barbary wolfberry fruit...... 1332 Assay of human protein S (2.7.31.) ...... 300 ...... 1923 Assay of human von Willebrand factor (2.7.21.)...... 290 chloratum for homoeopathic preparations ...... 1705 Assay of interferons (5.6.)...... 741 dihydrate for homoeopathic Assay of pertussis vaccine (acellular) (2.7.16.)...... 286 preparations ...... 1705 Assay of pertussis vaccine (whole cell) (2.7.7.) ...... 274 ...... 1924 Assay of poliomyelitis vaccine (inactivated), in vivo Basic butylated methacrylate copolymer...... 1925 (2.7.20.) ...... 289 BCG for immunotherapy...... 948 Assay of tetanus vaccine (adsorbed) (2.7.8.) ...... 275 BCG vaccine, freeze-dried...... 949 Assays (2.5.)...... 167 Bearberry leaf...... 1333 Astragalus mongholicus root ...... 1325 dipropionate...... 1926 sulfate ...... 1885 Beclometasone dipropionate monohydrate...... 1929 ...... 1887 Beeswax, white ...... 1931 Atomic absorption spectrometry (2.2.23.) ...... 37 Beeswax, yellow...... 1932 Atomic emission spectrometry (2.2.22.)...... 36 Belamcanda chinensis rhizome...... 1334 Atomic emission spectrometry, inductively coupled plasma- Belladonna for homoeopathic preparations...... 1705 (2.2.57.) ...... 106 Belladonna leaf...... 1336 hydrochloride ...... 1889 Belladonna leaf dry extract, standardised ...... 1337 Atorvastatin calcium trihydrate...... 1890 Belladonna leaf tincture, standardised...... 1338 ...... 1892 Belladonna, prepared ...... 1339 Atractylodes lancea rhizome...... 1327 Benazepril hydrochloride ...... 1932 Atractylodes rhizome, largehead ...... 1328 Bendroflumethiazide...... 1934 ...... 1894 ...... 1935 ...... 1897 hydrochloride...... 1936 Atropine sulfate...... 1898 Bentonite...... 1938 Aucklandia root ...... 1329 ...... 1938 Aujeszky’s disease vaccine (inactivated) for pigs ...... 1055 Benzalkonium chloride solution...... 1940 Aujeszky’s disease vaccine (live) for pigs for parenteral Benzathine tetrahydrate...... 1951 administration...... 1057 Benzathine G tetrahydrate ...... 1951 Aurothiomalate, sodium...... 3804 Benzathine penicillin V tetrahydrate ...... 3531 Aurum chloratum natronatum for homoeopathic Benzathine phenoxymethylpenicillin tetrahydrate ...... 3531 preparations ...... 1704 ...... 1942 Automatic rolling ball and falling ball viscometer methods Benzenesulfonate (methyl, ethyl and isopropyl) in active (2.2.49.) ...... 94 substances (2.5.41.)...... 186 Avian infectious bronchitis vaccine (inactivated)...... 1059 ...... 1943 Avian infectious bronchitis vaccine (live)...... 1060 ...... 1944 Avian infectious bursal disease vaccine (inactivated) ...... 1062 ...... 1945 Avian infectious bursal disease vaccine (live)...... 1063 Benzoin, Siam ...... 1341 Avian infectious encephalomyelitis vaccine (live)...... 1065 Benzoin, Sumatra...... 1341 Avian infectious laryngotracheitis vaccine (live)...... 1066 Benzoin tincture, Siam...... 1342 Avian live virus vaccines: tests for extraneous agents in batches Benzoin tincture, Sumatra...... 1343 of finished product (2.6.25.)...... 227 , hydrous ...... 1946 Avian paramyxovirus 1 (Newcastle disease) vaccine hydrochloride ...... 1947 (inactivated) ...... 1134 ...... 1949 Avian paramyxovirus 1 (Newcastle disease) vaccine ...... 1950 (live) ...... 1136 Benzylpenicillin (benzathine) tetrahydrate...... 1951 Avian paramyxovirus 3 vaccine (inactivated) for turkeys.. 1068 Benzylpenicillin potassium ...... 1953 Avian tuberculin purified protein derivative...... 4119 Benzylpenicillin () monohydrate...... 1955 Avian viral tenosynovitis vaccine (live) ...... 1069 Benzylpenicillin sodium ...... 1957

4264 See the information section on general monographs (cover pages) EUROPEAN PHARMACOPOEIA 10.0 Index

Betacarotene...... 1959 Blood containing anticoagulant solution, human, sterile Betacyclodextrin ...... 1960 containers of plasticised poly(vinyl chloride) for (3.3.6.).. 474 Betacyclodextrin, poly(hydroxypropyl) ether ...... 2901 Blood, human anticoagulant and preservative solutions Betacyclodextrin, sodium 4-sulfonatobutyl ether ...... 3935 for ...... 1856 Betadex...... 1960 Bogbean leaf ...... 1360 Betahistine dihydrochloride...... 1962 Boiling point (2.2.12.) ...... 31 Betahistine mesilate...... 1963 Boldine...... 1990 ...... 1964 Boldo leaf...... 1361 ...... 1966 Boldo leaf dry extract...... 1363 Betamethasone dipropionate...... 1968 Borage (starflower) oil, refined ...... 1992 Betamethasone sodium phosphate...... 1970 Borax ...... 1992 ...... 1971 Bordetella bronchiseptica vaccine (live) for ...... 1070 hydrochloride...... 1973 ...... 1993 Bezafibrate ...... 1975 Botulinum antitoxin...... 1169 ...... 1976 type A for injection ...... 1993 ...... 1977 Botulinum toxin type B for injection...... 1995 Bilberry fruit, dried ...... 1343 Bovine insulin ...... 2946 Bilberry fruit dry extract, fresh, refined and standardised..1442 Bovine leptospirosis vaccine (inactivated) ...... 1071 Bilberry fruit, fresh...... 1344 Bovine parainfluenza virus vaccine (live)...... 1073 Biological assays (2.7.) ...... 261 Bovine respiratory syncytial virus vaccine (live)...... 1074 Biological assays and tests, statistical analysis of results of Bovine rhinotracheitis vaccine (inactivated), infectious ... 1120 (5.3.) ...... 685 Bovine rhinotracheitis vaccine (live), infectious ...... 1121 Biological indicators and related microbial preparations used Bovine serum ...... 1996 in the manufacture of sterile products (5.1.2.) ...... 622 Bovine tuberculin purified protein derivative...... 4120 Biological products, general texts on (5.2.) ...... 647 Bovine viral diarrhoea vaccine (inactivated) ...... 1075 Biological products, terminology used in monographs on tartrate ...... 1998 (5.2.1.) ...... 647 ...... 1999 Biological tests (2.6.) ...... 191 hydrochloride...... 2000 Biotherapeutic products for human use, live ...... 876 mesilate...... 2001 Biotherapeutic products (live), microbiological examination of ...... 2003 (tests for enumeration of microbial contaminants) (2.6.36.) Bromperidol decanoate...... 2005 ...... 250 maleate...... 2007 Biotherapeutic products (live), microbiological examination Bronchitis vaccine (inactivated), infectious, avian...... 1059 of (tests for specified micro-organisms) (2.6.38.)...... 255 Bronchitis vaccine (live), infectious, avian...... 1060 ...... 1979 ...... 2008 hydrochloride...... 1980 Brucellosis vaccine (live) (Brucella melitensis Rev. 1 strain) for Biphasic insulin injection ...... 2953 veterinary use...... 1076 Biphasic isophane insulin injection...... 2953 Buccal tablets and sublingual tablets...... 922 Birch leaf...... 1345 Buckwheat herb ...... 1364 ...... 1982 ...... 2009 subcarbonate...... 1983 ...... 2011 Bismuth subgallate...... 1984 Buffer solutions (4.1.3.)...... 602 Bismuth subnitrate, heavy ...... 1985 Buflomedil hydrochloride...... 2012 Bismuth subsalicylate...... 1986 Bulk density and tapped density of powders (2.9.34.) ...... 384 fumarate...... 1986 ...... 2014 Bistort rhizome ...... 1347 hydrochloride...... 2015 Bitter fennel...... 1433 Bupleurum root ...... 1365 Bitter-fennel fruit oil ...... 1348 ...... 2017 Bitter-fennel herb oil...... 1350 Buprenorphine hydrochloride ...... 2019 Bitterness value (2.8.15.)...... 310 Bursal disease vaccine (inactivated), infectious, avian...... 1062 Bitter-orange epicarp and mesocarp...... 1352 Bursal disease vaccine (live), infectious, avian...... 1063 Bitter-orange flower...... 1353 Buserelin ...... 2020 Bitter-orange-epicarp and mesocarp tincture...... 1353 hydrochloride ...... 2022 Bitter-orange-flower oil...... 1550 Busulfan ...... 2024 Black cohosh...... 1355 Butcher’s broom...... 1367 Black horehound...... 1358 Butyl parahydroxybenzoate...... 2025 Blackcurrant leaf...... 1359 Butylated methacrylate copolymer, basic...... 1925 Bleomycin sulfate...... 1989 Butylhydroxyanisole...... 2026 Blood and blood components, human, empty sterile containers Butylhydroxytoluene ...... 2027 of plasticised poly(vinyl chloride) for (3.3.5.)...... 473 Blood and blood components, human, materials based C on plasticised poly(vinyl chloride) for containers for ...... 2031 (3.3.2.) ...... 465 Cachets...... 907 Blood and blood components, human, materials for containers sulfate hydrate for homoeopathic prepara- for (3.3.1.)...... 465 tions...... 1707 Blood and blood components, human, sterile plastic Cadmium sulfuricum for homoeopathic preparations...... 1707 containers for (3.3.4.)...... 471 ...... 2032 Blood and blood components, materials based on plasticised Caffeine monohydrate...... 2033 poly(vinyl chloride) for tubing used in sets for the transfusion monohydrate ...... 2035 of (3.3.3.)...... 468 ...... 2036 Blood and blood components, sets for the transfusion of Calcipotriol monohydrate ...... 2038 (3.3.7.) ...... 475 Calcitonin (salmon)...... 2040

General Notices (1) apply to all monographs and other texts 4265 Index EUROPEAN PHARMACOPOEIA 10.0

Calcitriol ...... 2043 ...... 2075 Calcium (2.4.3.)...... 138 Caraway fruit...... 1376 ...... 2044 Caraway oil...... 1377 Calcium ascorbate ...... 2045 ...... 2078 ...... 2046 ...... 2078 Calcium carboxymethylcellulose...... 2093 Carbasalate calcium...... 2080 dihydrate...... 2047 ...... 2081 Calcium chloride hexahydrate ...... 2047 ...... 2083 monohydrate...... 2048 ...... 2084 Calcium edetate, sodium ...... 3807 Carbomers ...... 2085 Calcium fluoratum for homoeopathic preparations ...... 1707 Carbon dioxide ...... 2086 Calcium folinate hydrate...... 2049 Carbon dioxide in gases (2.5.24.) ...... 174 ...... 2051 Carbon monoxide...... 2088 ...... 2052 Carbon monoxide (15O)...... 1184 Calcium gluconate, anhydrous...... 2052 Carbon monoxide in gases (2.5.25.)...... 175 Calcium gluconate for injection ...... 2053 Carbon monoxide intermix (5 per cent) in nitrogen...... 2089 Calcium glycerophosphate ...... 2054 Carboplatin...... 2089 Calcium hydrogen phosphate ...... 2055 trometamol ...... 2090 Calcium hydrogen phosphate dihydrate...... 2056 Carboxymethylcellulose...... 2092 Calcium hydroxide ...... 2057 Carboxymethylcellulose calcium...... 2093 Calcium in adsorbed vaccines (2.5.14.) ...... 172 Carboxymethylcellulose sodium...... 2093 Calcium iodatum for homoeopathic preparations...... 1708 Carboxymethylcellulose sodium, cross-linked ...... 2318 Calciumiodidetetrahydrateforhomoeopathic Carboxymethylcellulose sodium, low-substituted...... 2094 preparations ...... 1708 ...... 2091 ...... 2058 Carmellose...... 2092 Calcium lactate monohydrate ...... 2058 Carmellose calcium ...... 2093 Calcium lactate pentahydrate...... 2059 Carmellose sodium...... 2093 Calcium lactate trihydrate ...... 2059 Carmellose sodium and microcrystalline ...... 3269 Calcium levofolinate hydrate ...... 2060 Carmellose sodium, low-substituted...... 2094 Calcium levulinate dihydrate ...... 2062 Carmustine...... 2095 Calcium pantothenate...... 2063 Carnauba ...... 2096 Calcium pentetate (sodium) for for veterinary use...... 2097 preparations ...... 1223 Carrageenan ...... 2098 Calcium phosphate...... 2065 Carrier proteins for the production of conjugated Calcium stearate ...... 2065 polysaccharide vaccines for human use (5.2.11.) ...... 674 dihydrate...... 2067 hydrochloride...... 2099 Calendula flower...... 1368 ...... 2101 Calf coronavirus diarrhoea vaccine (inactivated)...... 1077 Cascara...... 1378 Calf rotavirus diarrhoea vaccine (inactivated)...... 1078 Cascara dry extract, standardised...... 1380 Calicivirosis vaccine (inactivated), feline ...... 1106 Cassia oil...... 1381 Calicivirosis vaccine (live), feline ...... 1107 , hydrogenated...... 2102 , D-...... 2067 Castor oil, polyoxyl...... 3144 Camphor, racemic ...... 2069 Castor oil, polyoxyl hydrogenated...... 3144 Candesartan cilexetil...... 2070 Castor oil, refined ...... 2103 Canine adenovirus vaccine (inactivated)...... 1079 Castor oil, virgin ...... 2104 Canine adenovirus vaccine (live)...... 1080 Catgut, sterile ...... 1269 Canine distemper vaccine (live) ...... 1081 Catgut, sterile, in distributor for veterinary use ...... 1281 Canine leptospirosis vaccine (inactivated) ...... 1082 CD34/CD45+ cells in haematopoietic products, numeration Canine parainfluenza virus vaccine (live) ...... 1084 of (2.7.23.)...... 292 Canine parvovirosis vaccine (inactivated)...... 1085 Cefaclor...... 2105 Canine parvovirosis vaccine (live)...... 1086 Cefadroxil monohydrate...... 2106 Cape aloes...... 1302 Cefalexin monohydrate...... 2108 Cape jasmine fruit ...... 1369 Cefalotin sodium ...... 2109 Capecitabine...... 2072 Cefamandole nafate...... 2111 Capillary electrophoresis (2.2.47.)...... 87 Cefapirin sodium...... 2112 Capillary viscometer method (2.2.9.)...... 27 Cefatrizine propylene glycol...... 2113 Caprylate, sodium...... 3808 Cefazolin sodium...... 2114 Caprylic acid ...... 2073 Cefepime dihydrochloride monohydrate ...... 2117 Caprylocaproyl macrogolglycerides ...... 2074 Cefixime...... 2119 Capsicum ...... 1371 Cefoperazone sodium ...... 2120 Capsicum oleoresin, refined and standardised ...... 1373 Cefotaxime sodium ...... 2122 Capsicum soft extract, standardised ...... 1374 Cefoxitin sodium ...... 2124 Capsicum tincture, standardised ...... 1375 Cefpodoxime proxetil ...... 2126 Capsules ...... 906 Cefprozil monohydrate...... 2128 Capsules and tablets, disintegration of (2.9.1.) ...... 323 ...... 2130 Capsules, gastro-resistant ...... 907 Ceftazidime pentahydrate...... 2132 Capsules, hard...... 906 Ceftazidime pentahydrate with for Capsules, intrauterine ...... 914 injection...... 2134 Capsules, modified-release ...... 907 Ceftriaxone sodium...... 2136 Capsules, oromucosal...... 922 Cefuroxime axetil ...... 2138 Capsules, rectal ...... 934 Cefuroxime sodium...... 2139 Capsules, soft...... 906 Celandine, greater...... 1463 Capsules, vaginal...... 941 ...... 2141

4266 See the information section on general monographs (cover pages) EUROPEAN PHARMACOPOEIA 10.0 Index

Celiprolol hydrochloride ...... 2142 maleate ...... 2187 Cell count and viability, nucleated (2.7.29.)...... 297 hydrochloride ...... 2188 Cell cultures for the production of veterinary vaccines hydrochloride...... 2189 (5.2.4.) ...... 654 Chlortalidone ...... 2191 Cell substrates for the production of vaccines for human use hydrochloride...... 2193 (5.2.3.) ...... 650 ...... 2195 Cell-based and gene therapy medicinal products, raw materials Cholecalciferol concentrate (oily form)...... 2197 of biological origin for the production of (5.2.12.) ...... 675 Cholecalciferol concentrate (powder form) ...... 2198 Cell-based preparations, microbiological examination of Cholecalciferol concentrate (water-dispersible form)...... 2199 (2.6.27.) ...... 231 vaccine (inactivated), fowl...... 1117 Cellulose acetate ...... 2143 Cholera vaccine (inactivated, oral)...... 951 Cellulose acetate butyrate ...... 2144 Cholesterol...... 2201 Cellulose acetate ...... 2145 Cholesterol for parenteral use...... 2202 Cellulose, microcrystalline ...... 2146 Cholesterol in oils rich in omega-3 acids, total (2.4.32.) ..... 163 Cellulose (microcrystalline) and carmellose sodium...... 3269 ([11C]methyl) injection...... 1185 Cellulose, powdered ...... 2150 sodium ...... 2203 Centaury ...... 1382 Chromatographic separation techniques (2.2.46.) ...... 80 Centella ...... 1383 Chromatography, gas (2.2.28.)...... 48 dihydrochloride ...... 2153 Chromatography, liquid (2.2.29.) ...... 49 Cetostearyl alcohol...... 2155 Chromatography, paper (2.2.26.) ...... 46 Cetostearyl alcohol (type A), emulsifying...... 2156 Chromatography, size-exclusion (2.2.30.) ...... 51 Cetostearyl alcohol (type B), emulsifying ...... 2157 Chromatography, supercritical fluid (2.2.45.)...... 80 Cetostearyl isononanoate ...... 2159 Chromatography, thin-layer (2.2.27.) ...... 47 Cetostearyl sulfate, sodium ...... 3810 (51Cr) edetate injection ...... 1186 ...... 2159 Chymotrypsin ...... 2205 ...... 2160 ...... 2206 Cetyl palmitate...... 2160 ...... 2208 ...... 2161 Ciclopirox olamine ...... 2209 Ceylon cinnamon bark oil...... 1391 Ciclosporin ...... 2210 Ceylon cinnamon leaf oil...... 1391 sodium...... 2212 CFC assay for human haematopoietic progenitor cells Cilazapril...... 2214 (2.7.28.) ...... 296 ...... 2215 Chamomile flower, Roman ...... 1384 Cimetidine hydrochloride ...... 2217 Characterisation of crystalline and partially crystalline solids hydrochloride...... 2218 by X-ray powder diffraction (XRPD) (2.9.33.)...... 379 Cinchona bark...... 1387 Characterisation of crystalline solids by microcalorimetry and Cinchona liquid extract, standardised ...... 1389 solution calorimetry (2.2.61.)...... 115 Cineole ...... 2220 Characterisation of preparations for nebulisation (2.9.44.).. 404 Cineole in essential oils, 1,8-, assay of (2.8.11.)...... 307 Characters section in monographs (5.11.) ...... 769 Cineole type niaouli oil...... 1554 Charcoal, activated ...... 2162 Cinnamon...... 1390 Chemical imaging (5.24.) ...... 847 Cinnamon bark oil, Ceylon...... 1391 Chemical precursors for radiopharmaceutical Cinnamon leaf oil, Ceylon...... 1391 preparations ...... 863 ...... 2221 Chemometric methods applied to analytical data (5.21.) ... 819 Ciprofibrate ...... 2222 Chenodeoxycholic acid ...... 2163 Ciprofloxacin...... 2223 Chewable tablets ...... 939 Ciprofloxacin hydrochloride ...... 2225 Chewing gums, medicated ...... 907 Circular dichroism (2.2.41.) ...... 75 Chewing gums, medicated, dissolution test for (2.9.25.)..... 365 ...... 2226 Chicken anaemia vaccine (live), infectious ...... 1122 Cisplatin...... 2231 Chicken flocks free from specified pathogens for the hydrobromide...... 2232 production and quality control of vaccines (5.2.2.) ...... 647 Citalopram hydrochloride...... 2234 Chinese goldthread rhizome ...... 1386 ...... 2235 Chitosan hydrochloride ...... 2164 Citric acid monohydrate...... 2236 Chlamydiosis vaccine (inactivated), feline ...... 1108 Citronella oil...... 1392 hydrate ...... 2165 Cladribine...... 2237 Chlorambucil ...... 2166 ...... 2238 Chloramine...... 4074 Clarity and degree of opalescence of liquids (2.2.1.)...... 21 ...... 2167 Clary sage oil...... 1393 Chloramphenicol palmitate...... 2168 Classical swine- vaccine (live, prepared in cell Chloramphenicol sodium succinate...... 2170 cultures) ...... 1159 hydrochloride...... 2171 Clazuril for veterinary use...... 2241 ...... 2172 malate ...... 2243 Chlordiazepoxide hydrochloride...... 2173 fumarate ...... 2244 diacetate...... 2174 Clematis armandii stem...... 1394 Chlorhexidine digluconate solution...... 2176 hydrochloride ...... 2246 Chlorhexidine dihydrochloride ...... 2178 hydrochloride ...... 2247 Chlorides (2.4.4.) ...... 138 Clindamycin phosphate ...... 2248 acetate...... 2180 ...... 2251 ...... 2182 ...... 2252 Chlorobutanol hemihydrate...... 2183 propionate ...... 2253 Chlorocresol ...... 2184 butyrate...... 2255 Chloroquine phosphate ...... 2185 Clodronate disodium tetrahydrate ...... 2257 Chloroquine sulfate...... 2186 Clofazimine ...... 2258

General Notices (1) apply to all monographs and other texts 4267 Index EUROPEAN PHARMACOPOEIA 10.0

Clofibrate ...... 2259 Colistin sulfate ...... 2309 citrate ...... 2260 Colloidal anhydrous silica ...... 3787 hydrochloride ...... 2261 Colloidal hydrated silica ...... 3788 ...... 2263 Colloidal silica, hydrophobic ...... 3789 hydrochloride...... 2264 Colloidal , for external use ...... 3790 Clopamide ...... 2265 Colony-forming cell assay for human haematopoietic besilate...... 2267 progenitor cells (2.7.28.) ...... 296 Clopidogrel hydrochloride ...... 2268 Colophony ...... 1401 Clopidogrel hydrogen sulfate ...... 2270 Coloration of liquids (2.2.2.)...... 22 , dipotassium monohydrate ...... 2439 Common selfheal fruit-spike ...... 1401 Closantel sodium dihydrate for veterinary use...... 2272 Common stinging nettle for homoeopathic preparations.. 1728 Clostridium botulinum vaccine for veterinary use ...... 1087 Comparative table of porosity of sintered-glass filters Clostridium chauvoei vaccine for veterinary use ...... 1088 (2.1.2.) ...... 15 Clostridium novyi (type B) vaccine for veterinary use...... 1088 Complexometric titrations (2.5.11.)...... 170 Clostridium perfringens vaccine for veterinary use...... 1090 Composition of fatty acids by gas chromatography Clostridium septicum vaccine for veterinary use...... 1092 (2.4.22.) ...... 147 Closures and containers for parenteral preparations and Composition of fatty acids in oils rich in omega-3 acids ophthalmic preparations, polypropylene for (3.1.6.) ...... 431 (2.4.29.) ...... 161 Closures and containers for pharmaceutical use, plastic Compressed lozenges ...... 922 (3.2.2.) ...... 459 Concentrated solutions for haemodialysis ...... 2798 Closures and tubing, silicone elastomer for (3.1.9.)...... 436 Concentrated solutions for haemofiltration and Closures for containers for aqueous parenteral preparations, haemodiafiltration...... 2801 for powders and for freeze-dried powders, rubber Concentrates for injections or infusions...... 924 (3.2.9.) ...... 460 Concentrates for intrauterine solutions...... 914 ...... 2273 Conductivity (2.2.38.) ...... 66 Clove...... 1396 Coneflower herb, purple...... 1589 Clove oil...... 1396 Coneflower root, narrow-leaved...... 1548 Cloxacillin sodium ...... 2275 Coneflower root, pale...... 1568 ...... 2276 Coneflower root, purple...... 1591 Coagulation factor II, human, assay of (2.7.18.)...... 288 Conjugated ...... 2561 Coagulation factor IX, human ...... 2846 Conjugated polysaccharide vaccines for human use, carrier Coagulation factor IX, human, assay of (2.7.11.) ...... 281 proteins for the production of (5.2.11.) ...... 674 Coagulation factor IX (rDNA) concentrated solution, Consistency by penetrometry, measurement of (2.9.9.)...... 337 human ...... 2848 Containers (3.2.) ...... 453 CoagulationfactorIX(rDNA)powderforsolutionfor Containers and closures for parenteral preparations and injection, human...... 2853 ophthalmic preparations, polypropylene for (3.1.6.) ...... 431 Coagulation factor VII, human ...... 2838 Containers and closures for pharmaceutical use, plastic Coagulation factor VII, human, assay of (2.7.10.)...... 280 (3.2.2.) ...... 459 Coagulation factor VIIa (rDNA) concentrated solution, Containers and tubing for total parenteral nutrition human ...... 2840 preparations, poly(ethylene - vinyl acetate) for (3.1.7.)..... 434 Coagulation factor VIII, human...... 2844 Containers for aqueous solutions for infusion, plastic Coagulation factor VIII, human, assay of (2.7.4.) ...... 268 (3.2.2.1.) ...... 460 Coagulation factor VIII (rDNA), human ...... 2845 Containers for aqueous solutions for intravenous infusion, Coagulation factor X, assay of (2.7.19.) ...... 289 materials based on, plasticised poly(vinyl chloride) for Coagulation factor XI, human ...... 2855 (3.1.14.) ...... 445 Coagulation factor XI, human, assay of (2.7.22.) ...... 291 Containers for human blood and blood components, and Coagulation factors, activated (2.6.22.) ...... 224 materials used in their manufacture; transfusion sets and Coagulation factors, assay of heparin (2.7.12.)...... 281 materials used in their manufacture; syringes (3.3.)...... 463 Coated granules ...... 912 Containers for human blood and blood components, materials Coated tablets...... 938 based on plasticised poly(vinyl chloride) for (3.3.2.)...... 465 hydrochloride...... 2278 Containers for human blood and blood components, materials Coccidiosis vaccine (live) for chickens ...... 1094 for (3.3.1.)...... 465 Cocculus for homoeopathic preparations ...... 1708 Containers for human blood and blood components, plastic, Cocoa butter...... 2279 sterile (3.3.4.)...... 471 Coconut oil, refined...... 2279 Containers for non-injectable aqueous solutions, materials Cocoyl caprylocaprate...... 2280 based on non-plasticised poly(vinyl chloride) for hydrochloride dihydrate...... 2281 (3.1.10.) ...... 437 Codeine monohydrate...... 2283 Containers for parenteral preparations and for ophthalmic Codeine phosphate hemihydrate...... 2285 preparations, polyethylene with additives for (3.1.5.)...... 427 Codeine phosphate sesquihydrate ...... 2288 Containers for parenteral preparations and for ophthalmic Codergocrine mesilate ...... 2290 preparations, polyethylene without additives for (3.1.4.).. 426 Cod- oil, farmed...... 2291 Containers for pharmaceutical use, glass (3.2.1.)...... 453 Cod-liver oil (type A)...... 2295 Containers for preparations not for parenteral use, Cod-liver oil (type B) ...... 2299 polyethylene terephthalate for (3.1.15)...... 448 Codonopsis root ...... 1397 Containers for solid dosage forms for , Coix seed...... 1398 materials based on non-plasticised poly(vinyl chloride) for Cola ...... 1400 (3.1.11.) ...... 439 ...... 2303 Containers, materials used for the manufacture of (3.1.).... 423 Cold-water vibriosis vaccine (inactivated) for salmonids.. 1163 Containers of plasticised poly(vinyl chloride) for human blood Colestyramine ...... 2305 and blood components, empty sterile (3.3.5.)...... 473 Colibacillosis vaccine (inactivated), neonatal piglet ...... 1132 Containers of plasticised poly(vinyl chloride) for human blood Colibacillosis vaccine (inactivated), neonatal .... 1133 containing anticoagulant solution, sterile (3.3.6.)...... 474 Colistimethate sodium...... 2306

4268 See the information section on general monographs (cover pages) EUROPEAN PHARMACOPOEIA 10.0 Index

Contamination, microbial: microbial enumeration tests ...... 2332 (2.6.12.) ...... 201 Contamination, microbial: microbial enumeration tests (live D biotherapeutic products) (2.6.36.)...... 250 Dacarbazine...... 2337 Contamination, microbial: test for specified micro-organisms ...... 2338 (2.6.13.) ...... 205 sodium...... 2340 Contamination, microbial: tests for specified micro-organisms Dandelion herb with root...... 1408 (live biotherapeutic products) (2.6.38.) ...... 255 Dandelion root...... 1409 Content uniformity of single-dose preparations (2.9.6.) ..... 336 ...... 2342 Control of impurities in substances for pharmaceutical use Daunorubicin hydrochloride ...... 2343 (5.10.) ...... 763 D-Camphor...... 2067 Control of microbiological quality, alternative methods for Decyl oleate ...... 2344 (5.1.6.) ...... 628 ...... 2344 Copolymer, basic butylated methacrylate ...... 1925 Deferiprone oral solution ...... 2345 Copolymer, grafted, poly(vinyl alcohol) ...... 3140 Deferiprone tablets ...... 2346 Copolymer, methacrylic acid - ethyl acrylate (1:1)...... 3214 mesilate...... 2347 Copolymer, methacrylic acid - ethyl acrylate (1:1) dispersion Degree of coloration of liquids (2.2.2.) ...... 22 30 per cent...... 3216 Dembrexine hydrochloride monohydrate for veterinary Copolymer, methacrylic acid – methyl methacrylate use...... 2350 (1:1) ...... 3217 hydrochloride ...... 2351 Copolymer, methacrylic acid - methyl methacrylate Demonstrationofuniformityofdosageunitsusinglarge (1:2) ...... 3218 sample sizes (2.9.47.)...... 409 Copolymer (type A), ammonio methacrylate...... 1830 Density of powders, bulk density and tapped (2.9.34.)...... 384 Copolymer (type B), ammonio methacrylate ...... 1831 Density of solids (2.2.42.) ...... 76 Copovidone ...... 2311 Density of solids, gas pycnometric (2.9.23.)...... 364 acetate monohydrate for homoeopathic Density, relative (2.2.5.) ...... 25 preparations ...... 1711 Dental type silica ...... 3788 Copper for homoeopathic preparations ...... 1712 Depressor substances (2.6.11.)...... 200 Copper sulfate ...... 2313 citrate...... 2353 Copper sulfate pentahydrate ...... 2314 chloride...... 2354 Copper tetramibi tetrafluoroborate for radiopharmaceutical Desacyl-4′-monophosphoryl lipid A, 3-O- ...... 2355 preparations ...... 1187 Desflurane...... 2357 Coriander...... 1403 hydrochloride...... 2358 Coriander oil ...... 1404 ...... 2359 Coronavirus diarrhoea vaccine (inactivated), calf ...... 1077 Desloratadine ...... 2360 acetate ...... 2315 ...... 2361 Corydalis rhizome ...... 1405 ...... 2363 , absorbent...... 2316 Detection and measurement of radioactivity (2.2.66.) ...... 119 Cottonseed oil, hydrogenated ...... 2317 Detection, direct amperometric and pulsed electrochemical Couch grass rhizome...... 1407 (2.2.63.) ...... 117 Creams ...... 936 Detector tubes, gas (2.1.6.) ...... 17 , crude ...... 2318 Determination of aflatoxin B1 in herbal drugs (2.8.18.) ...... 311 Crocus for homoeopathic preparations...... 1710 Determination of bactericidal, fungicidal or yeasticidal activity Cromoglicate, sodium...... 3813 of antiseptic medicinal products (5.1.11.) ...... 643 Croscarmellose sodium ...... 2318 Determination of elemental impurities (2.4.20.)...... 144 Crospovidone...... 2319 Determinationofnitrogenbysulfuricaciddigestion ...... 2321 (2.5.9.) ...... 170 Crystalline and partially crystalline solids, characterisation Determination of primary aromatic amino-nitrogen by X-ray powder diffraction (XRPD) of (2.9.33.)...... 379 (2.5.8.) ...... 169 Crystalline solids, characterisation by microcalorimetry and Determination of water by distillation (2.2.13.) ...... 31 solution calorimetry (2.2.61.)...... 115 hydrochloride for veterinary use ...... 2364 Crystallinity (5.16.)...... 797 Devil’s claw dry extract ...... 1410 Cuprum aceticum for homoeopathic preparations...... 1711 Devil’s claw root...... 1411 Cuprum metallicum for homoeopathic preparations...... 1712 ...... 2365 Cutaneous application, liquid preparations for ...... 916 ...... 2367 Cutaneous application, powders for...... 925 Dexamethasone isonicotinate ...... 2369 Cutaneous application, semi-solid preparations for ...... 935 Dexamethasone sodium phosphate...... 2370 Cutaneous application, veterinary liquid preparations for.. 941 Dexamfetamine sulfate ...... 2373 Cutaneous foams ...... 916 Dexchlorpheniramine maleate...... 2374 Cutaneous patches...... 935 Dexpanthenol...... 2375 ...... 2322 1 for injection...... 2376 Cyanocobalamin (57Co) capsules...... 1188 57 Dextran 40 for injection ...... 2377 Cyanocobalamin ( Co) solution ...... 1188 Dextran 60 for injection ...... 2378 Cyanocobalamin (58Co) capsules...... 1189 58 Dextran 70 for injection ...... 2379 Cyanocobalamin ( Co) solution ...... 1189 ...... 2380 Cyclamate, sodium ...... 3814 Dextrans, molecular mass distribution in (2.2.39.)...... 68 hydrochloride...... 2323 Dextrin...... 2380 Cyclopentolate hydrochloride...... 2324 hydrobromide...... 2381 ...... 2326 tartrate ...... 2382 hydrochloride...... 2326 hydrochloride...... 2383 acetate...... 2327 Dextrose...... 2758 hydrochloride monohydrate...... 2329 Dextrose monohydrate...... 2761 Cystine ...... 2331

General Notices (1) apply to all monographs and other texts 4269 Index EUROPEAN PHARMACOPOEIA 10.0

Diacerein...... 2384 Diphtheria, tetanus, pertussis (acellular, component) and ...... 2386 poliomyelitis (inactivated) vaccine (adsorbed, reduced ...... 2388 antigen(s) content) ...... 966 diisetionate ...... 2388 Diphtheria, tetanus, pertussis (acellular, component), Dibutyl phthalate...... 2389 hepatitis B (rDNA), poliomyelitis (inactivated) and Dichlorobenzyl alcohol, 2,4- ...... 2390 haemophilus type b conjugate vaccine (adsorbed) ...... 968 ...... 3235 Diphtheria, tetanus, pertussis (acellular, component), for veterinary use...... 2391 poliomyelitis (inactivated) and haemophilus type b conjugate potassium...... 2393 vaccine (adsorbed) ...... 970 Diclofenac sodium...... 2394 Diphtheria, tetanus, pertussis (whole cell) and poliomyelitis sodium ...... 2396 (inactivated) vaccine (adsorbed) ...... 973 Dicyclomine hydrochloride...... 2397 Diphtheria, tetanus, pertussis (whole cell), poliomyelitis hydrochloride...... 2397 (inactivated) and haemophilus type b conjugate vaccine ...... 2398 (adsorbed) ...... 974 ...... 2400 Diphtheria vaccine (adsorbed)...... 977 Diethyl phthalate ...... 2402 Diphtheria vaccine (adsorbed), assay of (2.7.6.)...... 269 citrate...... 2403 Diphtheria vaccine (adsorbed, reduced antigen content) ... 978 Diethylene glycol and ethylene glycol in ethoxylated hydrochloride...... 2437 substances (2.4.30.)...... 163 Dipotassium clorazepate monohydrate ...... 2439 Diethylene glycol monoethyl ether ...... 2404 Dipotassium phosphate ...... 2440 Diethylene glycol palmitostearate...... 2405 ...... 2441 ...... 2406 ...... 2442 Diffraction, laser light, particle size analysis by (2.9.31.) ... 373 Direct amperometric and pulsed electrochemical detection Difloxacin hydrochloride trihydrate for veterinary use..... 2407 (2.2.63.) ...... 117 for homoeopathic preparations...... 1712 ...... 2444 Digitalis leaf...... 1412 Disintegration of suppositories and pessaries (2.9.2.) ...... 325 ...... 2409 Disintegration of tablets and capsules (2.9.1.) ...... 323 ...... 2410 Disodium clodronate tetrahydrate ...... 2257 Dihydralazine sulfate, hydrated ...... 2413 Disodium edetate...... 2445 hydrogen tartrate...... 2414 Disodium etidronate ...... 2589 mesilate...... 2415 Disodium pamidronate pentahydrate...... 3474 mesilate...... 2418 Disodium phosphate ...... 2446 sulfate for veterinary use ...... 2420 Disodium phosphate dihydrate...... 2447 ...... 2422 Disodium phosphate dodecahydrate...... 2447 hydrochloride...... 2423 ...... 2448 ...... 2425 Disopyramide phosphate...... 2449 ...... 2426 Dispersible tablets...... 939 Dimethyl sulfoxide ...... 2427 Dissolution, apparent (2.9.43.)...... 403 Dimethylacetamide ...... 2428 Dissolution, intrinsic (2.9.29.) ...... 372 Dimethylaniline, N,N- (2.4.26.) ...... 158 Dissolutiontestforlipophilicsoliddosageforms(2.9.42.)..401 Dimeticone ...... 2429 Dissolution test for medicated chewing gums (2.9.25.)...... 365 maleate ...... 2429 Dissolution test for solid dosage forms (2.9.3.) ...... 326 Dinoprost trometamol ...... 2431 Dissolution test for transdermal patches (2.9.4.)...... 333 Dinoprostone ...... 2432 Dissolution testing, recommendations on (5.17.1.) ...... 801 Dioscorea nipponica rhizome...... 1413 Distemper vaccine (live), canine...... 1081 Dioscorea oppositifolia rhizome...... 1414 Distemper vaccine (live) for mustelids ...... 1097 ...... 2433 Distillation range (2.2.11.)...... 30 Dioxan and ethylene oxide (2.4.25.)...... 157 Distribution estimation by analytical sieving, particle-size Dip concentrates...... 942 (2.9.38.) ...... 392 hydrochloride...... 2435 Disulfiram...... 2450 hydrochloride...... 2436 Dithranol ...... 2451 Diphtheria and tetanus toxins and toxoids, flocculation value DL- ...... 3225 (Lf) of, (Ramon assay) (2.7.27.)...... 295 DL-α-Tocopheryl hydrogen succinate...... 4062 Diphtheria and tetanus vaccine (adsorbed) ...... 952 DNA, residual host-cell, quantification and characterisation of Diphtheria and tetanus vaccine (adsorbed, reduced antigen(s) (2.6.35.) ...... 248 content)...... 953 Dobesilate monohydrate, calcium ...... 2048 Diphtheria antitoxin...... 1170 hydrochloride...... 2452 Diphtheria, tetanus and hepatitis B (rDNA) vaccine ...... 2453 (adsorbed) ...... 954 Docetaxel trihydrate...... 2455 Diphtheria, tetanus and pertussis (acellular, component) sodium ...... 2457 vaccine (adsorbed) ...... 955 Dodecyl gallate...... 2457 Diphtheria, tetanus and pertussis (acellular, component) rose...... 1415 vaccine (adsorbed, reduced antigen(s) content)...... 956 ...... 2458 Diphtheria, tetanus and pertussis (whole cell) vaccine Domperidone maleate...... 2460 (adsorbed) ...... 958 hydrochloride ...... 2461 Diphtheria, tetanus and poliomyelitis (inactivated) vaccine dihydrochloride ...... 2463 (adsorbed, reduced antigen(s) content)...... 959 Dorzolamide hydrochloride...... 2464 Diphtheria, tetanus, pertussis (acellular, component) and Dosage forms (glossary) ...... 905 haemophilus type b conjugate vaccine (adsorbed) ...... 961 Dosage units, demonstration of uniformity using large sample Diphtheria, tetanus, pertussis (acellular, component) and sizes (2.9.47.)...... 409 hepatitis B (rDNA) vaccine (adsorbed) ...... 963 Dosage units, uniformity of (2.9.40.) ...... 398 Diphtheria, tetanus, pertussis (acellular, component) and hydrochloride...... 2466 poliomyelitis (inactivated) vaccine (adsorbed)...... 964 DOTATOC (gallium (68Ga)) injection ...... 1208

4270 See the information section on general monographs (cover pages) EUROPEAN PHARMACOPOEIA 10.0 Index

Doxapram hydrochloride ...... 2467 Endotoxins, bacterial, guidelines for using the test for mesilate...... 2468 (5.1.10.) ...... 639 hydrochloride...... 2470 Enilconazole for veterinary use ...... 2500 Doxorubicin hydrochloride...... 2471 ...... 2502 hyclate...... 2472 ...... 2504 Doxycycline monohydrate...... 2474 Enrofloxacin for veterinary use...... 2505 hydrogen succinate...... 2476 ...... 2507 hydrochloride...... 2477 monohydrate...... 2508 Drop point (2.2.17.)...... 33 Enteric redmouth disease vaccine (inactivated) for rainbow ...... 2478 trout...... 1102 Droppers (2.1.1.)...... 15 Enumeration of microbial contaminants in live biotherapeutic Drops (nasal) and sprays (liquid nasal) ...... 919 products (2.6.36.)...... 250 Drops, oral...... 918 Enzootic vaccine (inactivated), porcine...... 1141 ...... 2480 Ephedra herb...... 1425 Dry extracts...... 868 ...... 2510 Dry residue of extracts (2.8.16.)...... 311 Ephedrine hemihydrate ...... 2511 Drying, loss on (2.2.32.)...... 57 Ephedrine hydrochloride...... 2511 Drynaria rhizome ...... 1416 Ephedrine hydrochloride, racemic...... 2513 Duck plague vaccine (live)...... 1098 Epinastine hydrochloride...... 2513 Duck viral hepatitis type I vaccine (live) ...... 1099 Epinephrine...... 1766 hydrochloride...... 2481 Epinephrine tartrate ...... 1767 ...... 2483 Epirubicin hydrochloride ...... 2514 Dwarf lilyturf tuber ...... 1418 ...... 2516 Dwarf pine oil ...... 1419 Eptacog alfa (activated) concentrated solution...... 2840 ...... 2485 Equine herpesvirus vaccine (inactivated)...... 1103 Equine influenza vaccine (inactivated)...... 1104 E Equisetum stem ...... 1426 Ear drops and ear sprays...... 908 ...... 2518 Ear powders...... 909 mesilates...... 2290 Ear preparations...... 908 maleate ...... 2520 Ear preparations, semi-solid ...... 908 tartrate ...... 2521 Ear sprays and ear drops...... 908 Erysipelas vaccine (inactivated), swine...... 1158 Ear tampons ...... 909 ...... 2522 Ear washes ...... 909 ...... 2524 Ebastine...... 2489 Erythromycin estolate ...... 2527 Eclipta herb ...... 1420 Erythromycin ethylsuccinate...... 2531 ...... 2490 Erythromycin lactobionate...... 2533 Econazole ...... 2491 Erythromycin stearate...... 2537 Edetate (chromium (51Cr)) injection...... 1186 Erythropoietin concentrated solution...... 2540 Edetate, disodium...... 2445 ...... 2544 Edetate, sodium calcium...... 3807 Escitalopram ...... 2546 Edetic acid ...... 2492 Eserine salicylate...... 3554 Edotreotide (gallium (68Ga)) injection...... 1208 hydrochloride...... 2548 Edrophonium chloride...... 2493 magnesium dihydrate ...... 2549 Effervescent granules ...... 912 Esomeprazole magnesium trihydrate...... 2551 Effervescent powders ...... 927 Esomeprazole sodium...... 2553 Effervescent tablets...... 939 Essential oils...... 864 Efficacy of antimicrobial preservation (5.1.3.)...... 625 Essential oils, assay of 1,8-cineole in (2.8.11.)...... 307 Efficacy of veterinary vaccines and immunosera, evaluation of Essential oils, fatty oils and resinified essential oils in (5.2.7.) ...... 661 (2.8.7.) ...... 306 Egg drop syndrome ′76 vaccine (inactivated)...... 1100 Essential oils, foreign esters in (2.8.6.)...... 306 Egg phospholipids for injection...... 2494 Essential oils in herbal drugs (2.8.12.)...... 307 Elder flower ...... 1421 Essential oils, odour and taste (2.8.8.) ...... 306 Electrochemical detection, pulsed, and direct amperometric Essential oils, residue on evaporation (2.8.9.)...... 306 detection (2.2.63.)...... 117 Essential oils, solubility in alcohol (2.8.10.) ...... 306 Electrophoresis (2.2.31.) ...... 51 Essential oils, water in (2.8.5.)...... 306 Electrophoresis, capillary (2.2.47.) ...... 87 Ester value (2.5.2.) ...... 167 Elemental impurities (5.20.)...... 815 benzoate ...... 2555 Elemental impurities, determination of (2.4.20.) ...... 144 Estradiol hemihydrate...... 2556 Eleutherococcus...... 1423 ...... 2557 Emedastine difumarate...... 2496 ...... 2559 Empty sterile containers of plasticised poly(vinyl chloride) for Estrogens, conjugated...... 2561 human blood and blood components (3.3.5.)...... 473 Etacrynic acid...... 2563 Emulsifying cetostearyl alcohol (type A)...... 2156 ...... 2565 Emulsifying cetostearyl alcohol (type B)...... 2157 Etanercept...... 2566 , solutions and suspensions, oral ...... 917 monohydrate...... 2570 Enalapril maleate ...... 2497 Ethambutol hydrochloride ...... 2571 Enalaprilat dihydrate...... 2499 Ethanol (96 per cent)...... 2573 Encephalitis vaccine (inactivated), tick-borne...... 1043 Ethanol, anhydrous...... 2575 Encephalomyelitis vaccine (live), infectious, avian ...... 1065 Ethanol content (2.9.10.) ...... 339 Endotoxins, bacterial (2.6.14.) ...... 209 Ether ...... 2577 Ether, anaesthetic...... 2577 ...... 2578

General Notices (1) apply to all monographs and other texts 4271 Index EUROPEAN PHARMACOPOEIA 10.0

Ethionamide ...... 2580 F ...... 2581 F0 concept to steam sterilisation of aqueous preparations, Ethoxylated substances, ethylene glycol and diethylene glycol application of (5.1.5.) ...... 628 in (2.4.30.) ...... 163 Factor II, human coagulation, assay of (2.7.18.)...... 288 ...... 2582 Factor IX, human coagulation ...... 2846 Ethyl acrylate - methacrylic acid copolymer (1:1)...... 3214 Factor IX, human coagulation, assay of (2.7.11.) ...... 281 Ethyl acrylate - methacrylic acid copolymer (1:1) dispersion Factor IX (rDNA) concentrated solution, human 30 per cent...... 3216 coagulation ...... 2848 Ethyl oleate ...... 2583 Factor IX (rDNA) powder for solution for injection, human Ethyl parahydroxybenzoate...... 2583 coagulation ...... 2853 Ethyl parahydroxybenzoate sodium...... 3816 Factor VII, human coagulation...... 2838 Ethylcellulose...... 2585 Factor VII, human coagulation, assay of (2.7.10.)...... 280 Ethylene glycol and diethylene glycol in ethoxylated substances Factor VIIa (rDNA) concentrated solution, human coagulation (2.4.30.) ...... 163 ...... 2840 Ethylene glycol monopalmitostearate ...... 2586 Factor VIII, human coagulation ...... 2844 Ethylene glycol monostearate...... 2586 Factor VIII, human coagulation, assay of (2.7.4.) ...... 268 Ethylene oxide and dioxan (2.4.25.) ...... 157 Factor VIII (rDNA), human coagulation ...... 2845 Ethylenediamine ...... 2587 Factor X, human coagulation, assay of (2.7.19.)...... 289 Ethylhexanoic acid, 2- (2.4.28.)...... 160 Factor XI, human coagulation ...... 2855 hydrochloride...... 2587 Factor XI, human coagulation, assay of (2.7.22.) ...... 291 Etidronate disodium...... 2589 Falling ball and automatic rolling ball viscometer methods hydrochloride...... 2589 (2.2.49.) ...... 94 ...... 2591 Famotidine...... 2609 ...... 2593 Fat, hard...... 2811 ...... 2595 Fat, hard with additives...... 2812 Etoposide ...... 2596 Fatty acids, composition by gas chromatography (2.4.22.).. 147 Eucalyptus leaf ...... 1428 Fatty acids in oils rich in omega-3 acids, composition of Eucalyptus oil ...... 1429 (2.4.29.) ...... 161 Eucommia bark...... 1430 Fatty oils, alkaline impurities in (2.4.19.) ...... 144 ...... 2599 Fatty oils and resinified essential oils in essential oils European goldenrod...... 1460 (2.8.7.) ...... 306 European viper venom antiserum ...... 1174 Fatty oils, foreign oils in, by thin-layer chromatography Evaluation of efficacy of veterinary vaccines and immunosera (2.4.21.) ...... 147 (5.2.7.) ...... 661 Fatty oils, identification by thin-layer chromatography Evaluation of safety of each batch of immunosera for (2.3.2.) ...... 132 veterinary use (5.2.9.)...... 673 Fatty oils, sterols in (2.4.23.)...... 150 Evaluation of safety of veterinary vaccines and immunosera Fatty oils, vegetable...... 901 (5.2.6.) ...... 658 Fc function of immunoglobulin, test for (2.7.9.)...... 279 Evening primrose oil, refined...... 2601 Febantel for veterinary use ...... 2610 Everolimus...... 2601 Feeding stuffs for veterinary use, medicated, premixes for.. 927 Evodia fruit...... 1431 ...... 2611 Excipients, functionality-related characteristics of (5.15.) .. 793 Feline calicivirosis vaccine (inactivated)...... 1106 ...... 2604 Feline calicivirosis vaccine (live)...... 1107 Extemporaneous preparation of Feline chlamydiosis vaccine (inactivated) ...... 1108 (5.19.) ...... 807 Feline infectious enteritis (feline panleucopenia) vaccine Extractablevolumeofparenteralpreparations,testfor (inactivated) ...... 1109 (2.9.17.) ...... 347 Feline infectious enteritis (feline panleucopenia) vaccine Extracts, dry ...... 868 (live) ...... 1110 Extracts, dry residue of (2.8.16.)...... 311 Feline leukaemia vaccine (inactivated) ...... 1112 Extracts, herbal drug...... 865 Feline panleucopenia vaccine (inactivated)...... 1109 Extracts, herbal drug, monographs on (information chapter) Feline panleucopenia vaccine (live) ...... 1110 (5.23.) ...... 843 Feline viral rhinotracheitis vaccine (inactivated) ...... 1113 Extracts, liquid (fluid)...... 867 Feline viral rhinotracheitis vaccine (live) ...... 1114 Extracts, loss on drying of (2.8.17.)...... 311 ...... 2612 Extracts, soft...... 867 Felypressin ...... 2614 Extracts used in the preparation of herbal medicinal products for veterinary use...... 2615 for oral use, microbiological examination (2.6.31.) ...... 239 ...... 2616 Extracts used in the preparation of herbal medicinal products Fennel, bitter ...... 1433 for oral use, microbiological quality (5.1.8.)...... 638 Fennel, sweet ...... 1434 Extracts, water for preparation of...... 4206 Fenofibrate...... 2617 Extraneous agents in viral vaccines for human use, tests for hydrobromide...... 2618 (2.6.16.) ...... 214 ...... 2619 Extraneous agents: tests in batches of finished product of Fentanyl citrate...... 2621 avian live virus vaccines (2.6.25.) ...... 227 nitrate...... 2622 Extraneous agents: tests in seed lots of avian viral vaccines Fenugreek ...... 1435 (2.6.24.) ...... 224 Fermentation, products of...... 882 Eye drops ...... 909 Ferric chloride hexahydrate...... 2624 Eye lotions ...... 910 Ferrous fumarate...... 2624 Eye preparations ...... 909 Ferrous gluconate ...... 2625 Eye preparations, semi-solid ...... 910 Ferrous sulfate, dried...... 2626 Ferrous sulfate heptahydrate ...... 2627 Ferrum metallicum for homoeopathic preparations ...... 1714

4272 See the information section on general monographs (cover pages) EUROPEAN PHARMACOPOEIA 10.0 Index

FET (18F) injection...... 1201 Folinate hydrate, calcium...... 2049 Feverfew...... 1436 Follitropin...... 2691 Fexofenadine hydrochloride...... 2628 Follitropin concentrated solution...... 2697 Fibrin sealant kit...... 2630 Foot-and-mouth disease () vaccine , human...... 2856 (inactivated) ...... 1115 Filgrastim concentrated solution...... 2631 Foreign esters in essential oils (2.8.6.)...... 306 Filgrastim injection ...... 2634 Foreign matter (2.8.2.) ...... 305 Films, orodispersible ...... 922 Foreign oils in fatty oils by thin-layer chromatography ...... 2636 (2.4.21.) ...... 147 Fineness, powder (2.9.35.)...... 387 Formaldehyde, free (2.4.18.)...... 143 Fingolimod hydrochloride...... 2637 Formaldehyde solution (35 per cent)...... 2703 for veterinary use...... 2639 Formic acid...... 2703 Fish oil, rich in omega-3 acids ...... 2639 fumarate dihydrate...... 2704 hydrochloride...... 2642 sodium hexahydrate ...... 2706 acetate...... 2643 Fosfomycin calcium...... 2708 Fleeceflower root...... 1437 Fosfomycin sodium ...... 2709 Flocculation value (Lf) of diphtheria and tetanus toxins and Fosfomycin trometamol...... 2710 toxoids (Ramon assay) (2.7.27.)...... 295 sodium ...... 2711 Flow cytometry (2.7.24.)...... 293 Fourstamen stephania root...... 1438 Flowability (2.9.16.)...... 346 Fowl cholera vaccine (inactivated) ...... 1117 FLT (18F) injection ...... 1181 Fowl-pox vaccine (live)...... 1118 ...... 2644 Framycetin sulfate ...... 2714 magnesium octahydrate ...... 2645 Frangula bark ...... 1439 Flucloxacillin sodium...... 2647 Frangula bark dry extract, standardised...... 1441 ...... 2649 Frankincense, Indian...... 1480 ...... 2650 Fraxinus rhynchophylla bark ...... 1441 Fludarabine phosphate...... 2652 Free formaldehyde (2.4.18.)...... 143 Fludeoxyglucose (18F) injection ...... 1190 Freezing point (2.2.18.)...... 35 acetate...... 2654 Fresh bilberry fruit dry extract, refined and standardised.. 1442 ...... 2655 Friability of granules and spheroids (2.9.41.)...... 400 Flumazenil (N-[11C]methyl) injection...... 1192 Friability of uncoated tablets (2.9.7.) ...... 336 Flumequine...... 2657 Fructose...... 2715 pivalate...... 2658 Fucus ...... 1494 dihydrochloride...... 2659 ...... 2716 ...... 2660 Fumitory ...... 1444 for veterinary use ...... 2661 Functional groups and ions, identification reactions of acetonide...... 2662 (2.3.1.) ...... 129 pivalate...... 2665 Functionality-related characteristics of excipients (5.15.)... 793 Fluorescein ...... 2666 Fungicidal, bactericidal or yeasticidal activity of antiseptic Fluorescein sodium ...... 2667 medicinal products, determination of (5.1.11.)...... 643 Fluoride (18F) solution for radiolabelling...... 1194 ...... 2718 Fluorides (2.4.5.)...... 138 Furunculosis vaccine (inactivated, oil-adjuvanted, injectable) Fluorimetry (2.2.21.) ...... 36 for salmonids...... 1119 Fluorocholine (18F) injection...... 1195 Fusidate, sodium...... 3818 Fluorodeoxythymidine (18F) injection ...... 1181 ...... 2719 (18F) (prepared by electrophilic substitution) injection...... 1197 G 18 Fluorodopa ( F) (prepared by nucleophilic substitution) ...... 2725 injection...... 1198 monohydrate ...... 2726 Fluoroethyl-L- (18F) injection ...... 1201 18 hydrate...... 2728 Fluoromisonidazole ( F) injection...... 1204 ...... 2730 Fluorouracil...... 2669 hydrobromide ...... 2731 hydrochloride...... 2670 Gallium (67Ga) citrate injection ...... 1206 dihydrochloride...... 2672 Gallium (68Ga) chloride solution for radiolabelling...... 1206 decanoate...... 2674 Gallium (68Ga) DOTATOC injection...... 1208 Fluphenazine dihydrochloride...... 2675 Gallium (68Ga) edotreotide injection ...... 1208 Fluphenazine enantate ...... 2677 Gammacyclodextrin...... 2734 monohydrochloride ...... 2679 Gammadex ...... 2734 ...... 2680 ...... 2735 ...... 2681 Gargles ...... 921 ...... 2682 Garlic for homoeopathic preparations...... 1701 propionate...... 2683 Garlic powder...... 1446 ...... 2685 Gas adsorption, specific surface area by (2.9.26.)...... 369 Fluvastatin sodium ...... 2686 Gas chromatography (2.2.28.)...... 48 maleate...... 2688 18 Gas detector tubes (2.1.6.) ...... 17 FMISO ( F) injection ...... 1204 Gas pycnometric density of solids (2.9.23.)...... 364 Foam index (2.8.24.)...... 317 Gases, carbon dioxide in (2.5.24.) ...... 174 Foams, cutaneous ...... 916 Gases, carbon monoxide in (2.5.25.)...... 175 Foams, intrauterine ...... 914 Gases, nitrogen monoxide and nitrogen dioxide in Foams, medicated ...... 911 (2.5.26.) ...... 176 Foams, rectal ...... 935 Gases, nitrous oxide in (2.5.35.) ...... 182 Foams, vaginal...... 941 Gases, oxygen in (2.5.27.) ...... 176 Folic acid hydrate...... 2690

General Notices (1) apply to all monographs and other texts 4273 Index EUROPEAN PHARMACOPOEIA 10.0

Gases, water in (2.5.28.)...... 176 hydrochloride...... 2787 Gas-gangrene antitoxin, mixed...... 1170 Granules...... 912 Gas-gangrene antitoxin (novyi)...... 1171 Granules and powders for oral solutions and suspensions.. 917 Gas-gangrene antitoxin (perfringens)...... 1171 Granules and powders for syrups...... 918 Gas-gangrene antitoxin (septicum)...... 1172 Granules and spheroids, friability of (2.9.41.)...... 400 Gastrodia rhizome...... 1447 Granules, coated ...... 912 Gastro-resistant capsules ...... 907 Granules, effervescent...... 912 Gastro-resistant granules...... 913 Granules, gastro-resistant...... 913 Gastro-resistant tablets ...... 938 Granules, modified-release...... 912 Gefitinib...... 2737 Greater celandine...... 1463 Gelatin...... 2738 Green tea...... 1464 Gels...... 936 ...... 2788 Gels for injections...... 925 Guaiacol ...... 2789 Gemcitabine hydrochloride...... 2739 ...... 2791 Gemfibrozil...... 2740 monosulfate...... 2792 Gene transfer medicinal products for human use (5.14.).... 779 Guar...... 1466 General notices (1.) ...... 3 Guar galactomannan...... 2793 General texts on biological products (5.2.) ...... 647 Guarana...... 1467 General texts on microbiology (5.1.) ...... 619 Guidelines for using the test for bacterial endotoxins Genetically modified cells...... 779 (5.1.10.) ...... 639 sulfate...... 2742 Guidelines for using the test for sterility (5.1.9.)...... 639 Gentian root ...... 1448 Gentian tincture...... 1449 H ...... 2744 Haemagglutinins, anti-A and anti-B (2.6.20.)...... 218 Ginger ...... 1450 Haematopoietic products, numeration of CD34/CD45+ cells Gingival solutions...... 921 in (2.7.23.) ...... 292 Ginkgo dry extract, refined and quantified...... 1451 Haematopoietic progenitor cells, human, colony-forming cell Ginkgo leaf ...... 1454 assay for (2.7.28.)...... 296 ...... 1455 Haematopoietic stem cells, human...... 2857 Ginseng dry extract ...... 1457 Haemodiafiltration and haemofiltration, concentrated Glass containers for pharmaceutical use (3.2.1.)...... 453 solutions for...... 2801 ...... 2746 Haemodiafiltration and haemofiltration, solutions for...... 2803 ...... 2747 Haemodialysis, concentrated solutions for ...... 2798 ...... 2749 Haemodialysis solutions, concentrated, water for ...... 2751 diluting...... 2797 Glossary (dosage forms) ...... 905 Haemodialysis, solutions for ...... 2798 Glucagon, human ...... 2753 Haemofiltration and haemodiafiltration, concentrated Glucoheptonate, calcium ...... 2051 solutions for...... 2801 hydrochloride...... 2754 Haemofiltration and haemodiafiltration, solutions for...... 2803 Glucosamine sulfate ...... 2755 Haemophilus type b and meningococcal group C conjugate Glucosamine sulfate ...... 2757 vaccine ...... 979 ...... 2758 Haemophilus type b (conjugate), diphtheria, tetanus and Glucose, liquid ...... 2759 pertussis (acellular, component) vaccine (adsorbed)...... 961 Glucose, liquid, spray-dried ...... 2760 Haemophilus type b (conjugate), diphtheria, tetanus, pertussis Glucose monohydrate ...... 2761 (acellular, component) and poliomyelitis (inactivated) ...... 2762 vaccine (adsorbed) ...... 970 ...... 2763 Haemophilus type b (conjugate), diphtheria, tetanus, pertussis Glycan analysis of glycoproteins (2.2.59.) ...... 109 (acellular, component), hepatitis B (rDNA) and poliomyelitis ...... 2765 (inactivated) vaccine (adsorbed) ...... 968 Glycerol (85 per cent) ...... 2766 Haemophilus type b (conjugate), diphtheria, tetanus, Glycerol dibehenate...... 2767 pertussis (whole cell) and poliomyelitis (inactivated) vaccine Glycerol distearate ...... 2768 (adsorbed) ...... 974 Glycerol formal ...... 2769 Haemophilus type b conjugate vaccine...... 980 Glycerol monocaprylate...... 2770 Haemorrhagic disease vaccine (inactivated), rabbit...... 1147 Glycerol monocaprylocaprate...... 2771 Halofantrine hydrochloride...... 2805 Glycerol monolinoleate...... 2772 ...... 2806 Glycerol mono-oleate...... 2773 ...... 2808 Glycerol monostearate 40-55 ...... 2774 ...... 2809 Glycerol triacetate...... 4083 Hamamelis bark...... 1468 Glyceryl trinitrate solution...... 2775 Hamamelis leaf...... 1469 ...... 2777 Hard capsules ...... 906 Glycoproteins, glycan analysis of (2.2.59.) ...... 109 Hard fat...... 2811 ...... 2779 Hard fat with additives...... 2812 Glycyrrhizate ammonium...... 1833 Hard paraffin...... 3483 Goldenrod...... 1458 Harmonisation, pharmacopoeial (5.8.)...... 755 Goldenrod, European...... 1460 Hawthorn berries...... 1470 Goldenseal rhizome...... 1461 Hawthorn leaf and flower...... 1471 Gonadorelin acetate...... 2781 Hawthorn leaf and flower dry extract...... 1472 Gonadotrophin, chorionic...... 2782 Hawthorn leaf and flower liquid extract, quantified...... 1473 Gonadotrophin, equine serum, for veterinary use...... 2783 HCP assays (2.6.34.)...... 244 ...... 2783 Healthy chicken flocks for the production of inactivated Grafted copolymer, macrogol poly(vinyl alcohol) ...... 3140 vaccines for veterinary use (5.2.13.)...... 679 ...... 2785

4274 See the information section on general monographs (cover pages) EUROPEAN PHARMACOPOEIA 10.0 Index

Heavy bismuth subnitrate...... 1985 Histamine (2.6.10.) ...... 200 Heavy kaolin...... 3031 Histamine dihydrochloride ...... 2825 Heavy ...... 3153 Histaminum for homoeopathic preparations ...... 1716 Heavy ...... 3159 Histidine ...... 2826 Heavy metals (2.4.8.)...... 139 Histidine hydrochloride monohydrate ...... 2827 Heavy metals in herbal drugs and herbal drug preparations Homatropine hydrobromide ...... 2829 (2.4.27.) ...... 158 Homatropine methylbromide ...... 2830 Hedera helix for homoeopathic preparations ...... 1715 Homoeopathic pillules, coated...... 1697 Helium ...... 2814 Homoeopathic pillules, impregnated...... 1697 Heparin, assay of (2.7.5.) ...... 269 Homoeopathic preparations...... 1679 Heparin calcium ...... 2814 Homoeopathic preparations, acidum picrinicum for ...... 1698 Heparin in coagulation factors, assay of (2.7.12.)...... 281 Homoeopathic preparations, acidum succinicum for...... 1698 Heparin sodium...... 2816 Homoeopathic preparations, Agaricus phalloides for ...... 1699 , low-molecular-mass ...... 2818 Homoeopathic preparations, Allium sativum for ...... 1701 Hepatitis A immunoglobulin, human...... 2858 Homoeopathic preparations, ammonium carbonicum Hepatitis A (inactivated, adsorbed) and typhoid polysaccharide for ...... 1701 vaccine ...... 982 Homoeopathic preparations, Anacardium for...... 1702 Hepatitis A (inactivated) and hepatitis B (rDNA) vaccine Homoeopathic preparations, Apis for...... 1703 (adsorbed) ...... 983 Homoeopathic preparations, arsenicum album for ...... 1704 Hepatitis A vaccine, assay of (2.7.14.)...... 284 Homoeopathic preparations, aurum chloratum natronatum Hepatitis A vaccine (inactivated, adsorbed)...... 984 for ...... 1704 Hepatitis A vaccine (inactivated, virosome) ...... 985 Homoeopathic preparations, barium chloratum for...... 1705 Hepatitis B immunoglobulin for intravenous administration, Homoeopathic preparations, Belladonna for...... 1705 human ...... 2859 Homoeopathic preparations, cadmium sulfuricum for..... 1707 Hepatitis B immunoglobulin, human ...... 2858 Homoeopathic preparations, calcium fluoratum for ...... 1707 Hepatitis B (rDNA), diphtheria and tetanus vaccine Homoeopathic preparations, calcium iodatum for ...... 1708 (adsorbed) ...... 954 Homoeopathic preparations, Cocculus for ...... 1708 Hepatitis B (rDNA), diphtheria, tetanus and pertussis Homoeopathic preparations, Crocus for ...... 1710 (acellular, component) vaccine (adsorbed)...... 963 Homoeopathic preparations, cuprum aceticum for...... 1711 Hepatitis B (rDNA), diphtheria, tetanus, pertussis (acellular, Homoeopathic preparations, cuprum metallicum for...... 1712 component), poliomyelitis (inactivated) and haemophilus Homoeopathic preparations, digitalis for ...... 1712 type b conjugate vaccine (adsorbed)...... 968 Homoeopathic preparations, ferrum metallicum for ...... 1714 Hepatitis B vaccine (rDNA) ...... 988 Homoeopathic preparations, hedera helix for ...... 1715 Hepatitis B vaccine (rDNA), assay of (2.7.15.)...... 285 Homoeopathic preparations, herbal drugs for...... 1680 virus (HCV), validation of nucleic acid Homoeopathic preparations, histaminum for ...... 1716 amplification techniques for the detection of HCV RNA in Homoeopathic preparations, hydrastis canadensis for...... 1716 plasma pools: guidelines ...... 219 Homoeopathic preparations, hyoscyamus for ...... 1717 Hepatitis type I vaccine (live), viral, duck ...... 1099 Homoeopathic preparations, hypericum for...... 1718 hydrochloride...... 2821 Homoeopathic preparations: introduction ...... 1679 Herbal drug extracts...... 865 Homoeopathic preparations, kalium bichromicum for..... 1721 Herbal drug extracts, monographs on (information chapter) Homoeopathic preparations, magnesium fluoratum for... 1722 (5.23.) ...... 843 Homoeopathic preparations, magnesium phosphoricum Herbal drug preparations ...... 869 for ...... 1722 Herbal drugs...... 869 Homoeopathic preparations, mother tinctures for ...... 1681 Herbal drugs and herbal drug preparations, heavy metals in Homoeopathic preparations, Nux-vomica for...... 1723 (2.4.27.) ...... 158 Homoeopathic preparations, petroleum rectificatum for.. 1725 Herbal drugs and herbal drug preparations, high-performance Homoeopathic preparations, pillules for...... 1696 thin-layer chromatography of (2.8.25.)...... 318 Homoeopathic preparations, for...... 1725 Herbal drugs, determination of aflatoxin B1 in (2.8.18.) ..... 311 Homoeopathic preparations, Staphysagria for...... 1726 Herbal drugs, essential oils in (2.8.12.)...... 307 Homoeopathic preparations, sulfur for ...... 1727 Herbal drugs for homoeopathic preparations...... 1680 Homoeopathic preparations, Urtica dioica for...... 1728 Herbal drugs: introduction ...... 1289 Homoeopathic stocks (methods of preparation of) and Herbal drugs, microscopic examination of (2.8.23)...... 317 potentisation ...... 1682 Herbal drugs: sampling and sample preparation (2.8.20.).. 313 Homoepathic preparations, Ignatia for...... 1719 Herbal drugs, tannins in (2.8.14.)...... 310 Honey...... 2831 Herbal drugs, test for aristolochic acids in (2.8.21) ...... 314 Honey bee for homoeopathic preparations...... 1703 Herbal medicinal products for oral use and extracts used in Hop strobile...... 1474 their preparation, microbiological examination (2.6.31.).. 239 Horse-chestnut...... 1475 Herbal medicinal products for oral use and extracts used in Horse-chestnut dry extract, standardised...... 1477 their preparation, microbiological quality (5.1.8.) ...... 638 Host-cell DNA, residual, quantification and characterisation Herbal preparations...... 869 of (2.6.35.)...... 248 Herbal substances...... 869 Host-cell protein assays (2.6.34.) ...... 244 Herbal teas...... 870 Houttuynia herb...... 1478 Herbal teas, instant...... 871 Human α-1-proteinase inhibitor ...... 2869 Herpes zoster (shingles) vaccine (live)...... 1036 Human α-1-proteinase inhibitor, assay of (2.7.32.)...... 300 Herpesvirus vaccine (inactivated), equine...... 1103 Human albumin injection, iodinated (125I) ...... 1210 diisetionate ...... 2822 Human albumin solution ...... 2832 ...... 2823 Human anti-D immunoglobulin ...... 2834 Hexosamines in polysaccharide vaccines (2.5.20.)...... 173 Human anti-D immunoglobulin, assay of (2.7.13.) ...... 282 ...... 2824 Human anti-D immunoglobulin for intravenous High-molecular-mass ...... 3147 administration...... 2835 High-performance thin-layer chromatography of herbal drugs Human antithrombin III, assay of (2.7.17.)...... 288 and herbal drug preparations (2.8.25.) ...... 318 Human antithrombin III concentrate ...... 2835

General Notices (1) apply to all monographs and other texts 4275 Index EUROPEAN PHARMACOPOEIA 10.0

Human C1-esterase inhibitor...... 2837 Hydrous wool fat ...... 4216 Human C1-esterase inhibitor, assay of (2.7.34.)...... 301 acetate...... 2892 Human coagulation factor II, assay of (2.7.18.)...... 288 Hydroxocobalamin chloride...... 2893 Human coagulation factor IX ...... 2846 Hydroxocobalamin sulfate...... 2894 Human coagulation factor IX, assay of (2.7.11.) ...... 281 ...... 2895 Human coagulation factor IX (rDNA) concentrated sulfate...... 2896 solution ...... 2848 Hydroxyethyl salicylate...... 2897 Human coagulation factor IX (rDNA) powder for solution for Hydroxyethyl starches...... 3892 injection...... 2853 Hydroxyethylcellulose...... 2898 Human coagulation factor VII...... 2838 Hydroxyethylmethylcellulose...... 3237 Human coagulation factor VII, assay of (2.7.10.)...... 280 Hydroxyl value (2.5.3.)...... 167 Human coagulation factor VIIa (rDNA) concentrated Hydroxypropyl starch...... 3888 solution ...... 2840 Hydroxypropyl starch, pregelatinised ...... 3890 Human coagulation factor VIII ...... 2844 Hydroxypropylbetadex...... 2901 Human coagulation factor VIII, assay of (2.7.4.) ...... 268 Hydroxypropylcellulose ...... 2903 Human coagulation factor VIII (rDNA) ...... 2845 Hydroxypropylcellulose, low-substituted ...... 2904 Human coagulation factor X, assay of (2.7.19.)...... 289 Hydroxypropylmethylcellulose ...... 2914 Human coagulation factor XI ...... 2855 Hydroxypropylmethylcellulose phthalate...... 2916 Human coagulation factor XI, assay of (2.7.22.) ...... 291 hydrochloride...... 2906 Human fibrinogen ...... 2856 ...... 2907 Human glucagon...... 2753 Hymenoptera venoms for allergen products...... 2908 Human haematopoietic progenitor cells, colony-forming cell Hyoscine ...... 2909 assay for (2.7.28.)...... 296 ...... 2910 Human haematopoietic stem cells...... 2857 Hyoscine hydrobromide ...... 2911 Human hepatitis A immunoglobulin...... 2858 sulfate...... 2913 Human hepatitis B immunoglobulin ...... 2858 Hyoscyamus for homoeopathic preparations ...... 1717 Human hepatitis B immunoglobulin for intravenous Hypericum...... 1631 administration...... 2859 Hypericum for homoeopathic preparations...... 1718 Human insulin ...... 2951 Hypromellose ...... 2914 Human measles immunoglobulin ...... 2859 Hypromellose phthalate...... 2916 Human normal immunoglobulin for intramuscular administration...... 2860 I Human normal immunoglobulin for intravenous ...... 2921 administration...... 2862 Iceland moss...... 1480 Human normal immunoglobulin for subcutaneous ICH (5.8.)...... 755 administration...... 2864 Ichthammol ...... 2923 Human papillomavirus vaccine (rDNA) ...... 989 Identification (2.3.)...... 129 Human plasma for fractionation ...... 2865 Identification and control of residual solvents (2.4.24.) ...... 152 Human plasma (pooled and treated for virus Identification of fatty oils by thin-layer chromatography inactivation) ...... 2867 (2.3.2.) ...... 132 Human plasmin inhibitor, assay of (2.7.25.)...... 295 Identification of phenothiazines by thin-layer chromatography Human protein C, assay of (2.7.30.)...... 299 (2.3.3.) ...... 133 Human protein S, assay of (2.7.31.)...... 300 Identification reactions of ions and functional groups Human prothrombin complex...... 2870 (2.3.1.) ...... 129 Human rabies immunoglobulin ...... 2871 ...... 2924 Human rubella immunoglobulin ...... 2872 Ifosfamide...... 2925 Human tetanus immunoglobulin ...... 2873 Ignatia for homoeopathic preparations ...... 1719 Human varicella immunoglobulin ...... 2875 mesilate ...... 2926 Human varicella immunoglobulin for intravenous Imidacloprid for veterinary use ...... 2929 administration...... 2875 monohydrate ...... 2930 Human von Willebrand factor...... 2875 hydrochloride ...... 2931 Human von Willebrand factor, assay of (2.7.21.)...... 290 Immunochemical methods (2.7.1.) ...... 261 Hyaluronate, sodium...... 3821 Immunoglobulin for human use, anti-T lymphocyte, Hyaluronidase ...... 2877 animal ...... 1858 hydrochloride...... 2878 Immunoglobulin for intramuscular administration, human Hydrastis canadensis for homoeopathic preparations...... 1716 normal...... 2860 Hydrochloric acid, concentrated ...... 2879 Immunoglobulin for intravenous administration, human Hydrochloric acid, dilute...... 2879 anti-D...... 2835 ...... 2879 Immunoglobulin for intravenous administration, human hydrogen tartrate 2.5-hydrate ...... 2881 hepatitis B...... 2859 ...... 2883 Immunoglobulin for intravenous administration, human ...... 2886 normal...... 2862 Hydrocortisone hydrogen succinate...... 2888 Immunoglobulin for intravenous administration, human solution (3 per cent) ...... 2889 varicella...... 2875 Hydrogen peroxide solution (30 per cent) ...... 2890 Immunoglobulin for subcutaneous administration, human Hydrogenated arachis oil...... 1869 normal...... 2864 Hydrogenated castor oil...... 2102 Immunoglobulin, human anti-D...... 2834 Hydrogenated cottonseed oil...... 2317 Immunoglobulin, human anti-D, assay of (2.7.13.) ...... 282 Hydrogenated soya-bean oil...... 3872 Immunoglobulin, human hepatitis A ...... 2858 Hydrogenated vegetable oils, nickel in (2.4.31.) ...... 163 Immunoglobulin, human hepatitis B...... 2858 Hydrogenated wool fat...... 4215 Immunoglobulin, human measles...... 2859 hydrochloride...... 2890 Immunoglobulin, human rabies ...... 2871 Hydrophobic colloidal silica...... 3789

4276 See the information section on general monographs (cover pages) EUROPEAN PHARMACOPOEIA 10.0 Index

Immunoglobulin, human rubella ...... 2872 Inhalation, preparations for ...... 927 Immunoglobulin, human tetanus...... 2873 Inhalation, preparations for: aerodynamic assessment of fine Immunoglobulin, human varicella...... 2875 particles (2.9.18.) ...... 347 Immunoglobulin, test for anticomplementary activity of Injectable insulin preparations...... 2959 (2.6.17.) ...... 216 Injections ...... 923 Immunoglobulin, test for Fc function of (2.7.9.)...... 279 Injections, gels for...... 925 Immunological veterinary medicinal products, substances of Injections or infusions, concentrates for ...... 924 animal origin for the production of (5.2.5.)...... 656 Injections or infusions, powders for...... 924 Immunonephelometry for vaccine component assay , myo- ...... 2944 (2.7.35.) ...... 301 Inserts, ophthalmic...... 910 Immunosera and vaccines, phenol in (2.5.15.) ...... 172 Instant herbal teas ...... 871 Immunosera and vaccines, veterinary, evaluation of efficacy Insulin aspart...... 2945 of (5.2.7.)...... 661 Insulin, bovine ...... 2946 Immunosera and vaccines, veterinary, evaluation of safety Insulin glargine ...... 2949 (5.2.6.) ...... 658 Insulin, human...... 2951 Immunosera for human use, animal...... 871 Insulin injection, biphasic ...... 2953 Immunosera for veterinary use...... 873 Insulin injection, biphasic isophane...... 2953 Immunosera for veterinary use, evaluation of the safety of Insulin injection, isophane ...... 2954 each batch (5.2.9.)...... 673 Insulin injection, soluble ...... 2954 Implants ...... 925 Insulin lispro ...... 2954 Impurities, elemental, determination of (2.4.20.)...... 144 Insulin, porcine...... 2957 Impurities in substances for pharmaceutical use, control of Insulin preparations, injectable...... 2959 (5.10.) ...... 763 Insulin zinc injectable ...... 2961 In vitro method(s) for the quality control of vaccines, Insulin zinc injectable suspension (amorphous) ...... 2962 substitution of in vivo method(s) by (5.2.14.)...... 679 Insulin zinc injectable suspension (crystalline)...... 2962 In vivo assay of poliomyelitis vaccine (inactivated) alfa-2 concentrated solution...... 2963 (2.7.20.) ...... 289 Interferon beta-1a concentrated solution ...... 2965 Inactivated vaccines for veterinary use, healthy chicken flocks -1b concentrated solution ...... 2968 for the production of (5.2.13.) ...... 679 Interferons, assay of (5.6.)...... 741 Indapamide...... 2932 International System (SI) units (1.)...... 3 Index, foam (2.8.24.) ...... 317 Intramammary preparations for veterinary use ...... 913 Indian frankincense...... 1480 Intraruminal delivery systems ...... 913 Indicators, approximate pH of solutions (2.2.4.)...... 25 Intrauterine capsules ...... 914 Indigo leaf...... 1481 Intrauterine foams...... 914 sulfate...... 2934 Intrauterine preparations for veterinary use...... 914 Indium (111In) chloride solution ...... 1211 Intrauterine solutions, suspensions...... 914 Indium (111In) oxine solution...... 1212 Intrauterine sticks...... 914 Indium (111In) pentetate injection ...... 1213 Intrauterine tablets ...... 914 ...... 2936 Intrinsic dissolution (2.9.29.) ...... 372 Inductively coupled plasma-atomic emission spectrometry (123I) injection ...... 1213 (2.2.57.) ...... 106 Iobenguane (131I) injection for diagnostic use...... 1214 Inductively coupled plasma-mass spectrometry (2.2.58.) ... 108 Iobenguane (131I) injection for therapeutic use...... 1215 Infectious bovine rhinotracheitis vaccine (inactivated)..... 1120 Iobenguane sulfate for radiopharmaceutical prepara- Infectious bovine rhinotracheitis vaccine (live)...... 1121 tions...... 1216 Infectious bronchitis vaccine (inactivated), avian ...... 1059 Iodinated (125I) human albumin injection ...... 1210 Infectious bronchitis vaccine (live), avian ...... 1060 Iodinated povidone ...... 3615 Infectious bursal disease vaccine (inactivated), avian...... 1062 Iodine ...... 2971 Infectious bursal disease vaccine (live), avian...... 1063 Iodine value (2.5.4.)...... 167 Infectious chicken anaemia vaccine (live)...... 1122 ...... 2971 Infectious encephalomyelitis vaccine (live), avian...... 1065 Iodohippurate (sodium) dihydrate for radiopharmaceutical Infectious enteritis vaccine (inactivated), feline ...... 1109 preparations ...... 1234 Infectious enteritis vaccine (live), feline ...... 1110 Iodomethylnorcholesterol (131I) injection...... 1217 Infectious laryngotracheitis vaccine (live), avian ...... 1066 ...... 2974 Infectious pancreatic necrosis vaccine (inactivated, Ionic concentration, potentiometric determination of using oil-adjuvanted, injectable) for salmonids ...... 1124 ion-selective electrodes (2.2.36.)...... 64 Infectious rhinotracheitis vaccine (live), turkey ...... 1162 Ions and functional groups, identification reactions of Infliximab concentrated solution...... 2938 (2.3.1.) ...... 129 Influenza vaccine (inactivated), equine ...... 1104 Ion-selective electrodes, potentiometric determination of Influenza vaccine (inactivated), porcine...... 1142 ionic concentration (2.2.36.) ...... 64 Influenza vaccine (live, nasal) ...... 992 ...... 2978 Influenza vaccine (split virion, inactivated) ...... 995 ...... 2980 Influenza vaccine (surface antigen, inactivated)...... 996 ...... 2981 Influenza vaccine (surface antigen, inactivated, prepared in ...... 2984 cell cultures) ...... 998 ...... 2986 Influenza vaccine (surface antigen, inactivated, Ipecacuanha liquid extract, standardised ...... 1483 virosome)...... 1000 Ipecacuanha, prepared ...... 1483 Influenza vaccine (whole virion, inactivated) ...... 1002 Ipecacuanha root ...... 1485 Influenza vaccine (whole virion, inactivated, prepared in cell Ipecacuanha tincture, standardised...... 1486 cultures) ...... 1003 Ipratropium bromide ...... 2988 Infrared absorption spectrophotometry (2.2.24.)...... 39 Irbesartan...... 2990 Infusions ...... 924 Irinotecan hydrochloride trihydrate...... 2991 Inhalation gas, krypton (81mKr)...... 1217 Iron (2.4.9.)...... 142 Inhalation powders...... 931 Iron for homoeopathic preparations...... 1714

General Notices (1) apply to all monographs and other texts 4277 Index EUROPEAN PHARMACOPOEIA 10.0

Irrigation, preparations for...... 932 Laryngotracheitis vaccine (live), infectious, avian ...... 1066 Isatis root ...... 1487 Laser light diffraction, particle size analysis by (2.9.31.) .... 373 ...... 2993 Laurilsulfate, sodium...... 3827 Isoconazole nitrate...... 2994 Lauromacrogol 400...... 3065 Isoelectric focusing (2.2.54.) ...... 95 Lauroyl macrogolglycerides...... 3068 Isoflurane...... 2996 Lavender flower ...... 1497 ...... 2997 ...... 1499 ...... 2998 Lavender oil, spike...... 1630 ...... 3000 Lead in sugars (2.4.10.) ...... 142 Isophane insulin injection ...... 2954 Leflunomide ...... 3069 hydrochloride ...... 3001 Lemon oil...... 1500 Isoprenaline sulfate...... 3002 Lemon verbena leaf ...... 1502 ...... 3003 Leptospirosis vaccine (inactivated), bovine...... 1071 Isopropyl isostearate...... 3004 Leptospirosis vaccine (inactivated), canine...... 1082 Isopropyl myristate...... 3004 ...... 3070 Isopropyl palmitate...... 3005 ...... 3071 , diluted ...... 3006 Leukaemia vaccine (inactivated), feline...... 1112 , diluted ...... 3007 ...... 3073 Isotherms (sorption-desorption) and water activity, for veterinary use ...... 3074 determination of (water-solid interactions) (2.9.39.)...... 394 Levamisole hydrochloride ...... 3075 ...... 3009 ...... 3077 hydrochloride...... 3010 Levocabastine hydrochloride ...... 3078 Ispaghula husk ...... 1488 Levocarnitine...... 3080 Ispaghula seed...... 1489 Levodopa ...... 3082 ...... 3012 ...... 3083 ...... 3013 Levofloxacin hemihydrate ...... 3085 ...... 3015 Levofolinate hydrate, calcium ...... 2060 Ivy leaf...... 1489 Levomenthol...... 3086 hydrochloride...... 3087 J Levomepromazine maleate...... 3088 Java tea ...... 1491 hydrochloride...... 3089 Javanese turmeric...... 1652 ...... 3091 ...... 3021 sodium ...... 3094 Josamycin propionate...... 3023 Levulinate dihydrate, calcium...... 2062 Juniper...... 1492 ...... 3095 Juniper oil ...... 1493 Lidocaine hydrochloride monohydrate ...... 3097 Light liquid paraffin ...... 3483 K Light magnesium carbonate...... 3153 Light magnesium oxide...... 3160 Kalium bichromicum for homoeopathic preparations...... 1721 Lightyellow sophora root...... 1503 Kanamycin acid sulfate ...... 3029 Ligusticum root and rhizome ...... 1505 Kanamycin monosulfate ...... 3030 flower...... 1506 Kaolin, heavy...... 3031 Limit tests (2.4.) ...... 137 Kelp...... 1494 Limit tests, standard solutions for (4.1.2.)...... 598 hydrochloride ...... 3031 hydrochloride ...... 3098 hydrochloride ...... 3032 Linen thread, sterile, in distributor for veterinary use ..... 1282 ...... 3033 Linoleoyl macrogolglycerides...... 3100 ...... 3035 Linseed...... 1507 trometamol ...... 3037 Linseed oil, virgin...... 3101 hydrogen fumarate ...... 3038 sodium...... 3101 Knotgrass...... 1495 81m Lipophilic solid dosage forms, dissolution test for Krypton ( Kr) inhalation gas ...... 1217 (2.9.42.) ...... 401 Kudzuvine root ...... 1496 Liquid chromatography (2.2.29.)...... 49 Kudzuvine root, Thomson...... 1644 Liquid extraction preparations ...... 867 Liquid (fluid) extracts ...... 867 L Liquid glucose ...... 2759 hydrochloride...... 3043 Liquid glucose, spray-dried...... 2760 ...... 3045 Liquid ...... 3058 Lacosamide infusion ...... 3046 Liquid ...... 3171 Lacosamide oral solution...... 3047 Liquid paraffin ...... 3484 Lacosamide tablets...... 3049 Liquid paraffin, light ...... 3483 ...... 3050 Liquid preparations for cutaneous application...... 916 Lactic acid, (S)- ...... 3051 Liquid preparations for cutaneous application, veterinary.. 941 monohydrate...... 3051 Liquid preparations for oral use ...... 916 Lactobionic acid...... 3053 Liquid (crystallising)...... 3867 ...... 3054 Liquid sorbitol (non-crystallising) ...... 3867 Lactose monohydrate...... 3055 Liquid sorbitol, partially dehydrated...... 3868 Lactulose...... 3056 Liquid ...... 3908 Lactulose, liquid...... 3058 Liquids, clarity and degree of opalescence of (2.2.1.) ...... 21 ...... 3060 dry extract for flavouring purposes...... 1508 ...... 3063 Liquorice root ...... 1509 ...... 3064 Lisinopril dihydrate...... 3103 Largehead atractylodes rhizome...... 1328 carbonate ...... 3104

4278 See the information section on general monographs (cover pages) EUROPEAN PHARMACOPOEIA 10.0 Index

Lithium citrate ...... 3105 Magnesium glycerophosphate...... 3158 Live biotherapeutic products for human use ...... 876 ...... 3158 Live biotherapeutic products, microbiological examination dihydrate ...... 3159 of (tests for enumeration of microbial contaminants) Magnesium oxide, heavy ...... 3159 (2.6.36.) ...... 250 Magnesium oxide, light...... 3160 Live biotherapeutic products, microbiological examination of ...... 3161 (tests for specified micro-organisms) (2.6.38.) ...... 255 Magnesium phosphoricum for homoeopathic L-Methionine ([11C]methyl) injection...... 1220 preparations ...... 1722 hydrochloride...... 3105 ...... 3161 Lomustine...... 3107 Magnesium stearate...... 3163 Long pepper ...... 1510 heptahydrate...... 3165 Loosestrife ...... 1511 Magnesium trisilicate...... 3165 hydrochloride...... 3108 Magnolia biondii flower bud...... 1515 Loperamide oxide monohydrate...... 3109 Magnolia officinalis bark ...... 1517 ...... 3111 Magnolia officinalis flower ...... 1519 ...... 3114 Maize oil, refined ...... 3166 ...... 3116 Maize starch ...... 3167 potassium ...... 3117 ...... 3167 Loss on drying (2.2.32.) ...... 57 ...... 3168 Loss on drying of extracts (2.8.17.) ...... 311 Malic acid ...... 3169 Lovage root...... 1512 Mallow flower...... 1520 ...... 3120 Mallow leaf ...... 1521 Low-molecular-mass heparins...... 2818 Maltitol...... 3170 Low-substituted carmellose sodium...... 2094 Maltitol, liquid ...... 3171 Low-substituted hydroxypropylcellulose...... 2904 Maltodextrin...... 3172 Lozenges and pastilles...... 922 Mandarin epicarp and mesocarp...... 1522 Lozenges, compressed...... 922 Mandarin oil...... 1524 Lubricant, silicone oil (3.1.8.)...... 436 Manganese gluconate ...... 3173 Lufenuron for veterinary use ...... 3121 Manganese glycerophosphate, hydrated ...... 3174 Lutetium (177Lu) solution for radiolabelling...... 1218 Manganese sulfate monohydrate ...... 3174 Lycopus lucidus herb...... 1514 Mannheimia vaccine (inactivated) for cattle...... 1125 ...... 3123 Mannheimia vaccine (inactivated) for sheep ...... 1126 ...... 3125 ...... 3175 Lyophilisates, oral ...... 939 hydrochloride ...... 3177 acetate ...... 3126 Marbofloxacin for veterinary use ...... 3178 Lysine hydrochloride...... 3127 Marek’s disease vaccine (live)...... 1128 Marshmallow leaf ...... 1525 M Marshmallow root ...... 1526 Macrogol 15 hydroxystearate ...... 3133 Mass spectrometry (2.2.43.) ...... 77 Macrogol 20 glycerol monostearate...... 3134 Mass spectrometry, inductively coupled plasma- (2.2.58.).. 108 Macrogol 30 dipolyhydroxystearate ...... 3135 Mass uniformity of delivered doses from multidose containers Macrogol 40 sorbitol heptaoleate...... 3135 (2.9.27.) ...... 372 Macrogol 6 glycerol caprylocaprate...... 3133 Mass uniformity of single-dose preparations (2.9.5.) ...... 335 Macrogol cetostearyl ether ...... 3136 Mastic...... 1526 Macrogol isotridecyl ether...... 3137 Mate leaf...... 1527 Macrogol lauryl ether...... 3137 Materials based on non-plasticised poly(vinyl chloride) Macrogol oleate...... 3139 for containers for non-injectable, aqueous solutions Macrogol oleyl ether...... 3140 (3.1.10.) ...... 437 Macrogol poly(vinyl alcohol) grafted copolymer ...... 3140 Materials based on non-plasticised poly(vinyl chloride) for Macrogol stearate...... 3142 containers for solid dosage forms for oral administration Macrogol stearyl ether ...... 3142 (3.1.11.) ...... 439 Macrogolglycerol cocoates...... 3143 Materials based on plasticised poly(vinyl chloride) for Macrogolglycerol hydroxystearate...... 3144 containers for aqueous solutions for intravenous infusion Macrogolglycerol ricinoleate...... 3144 (3.1.14.) ...... 445 Macrogols ...... 3145 Materials based on plasticised poly(vinyl chloride) for Macrogols, high-molecular-mass ...... 3147 containers for human blood and blood components ...... 3148 (3.3.2.) ...... 465 Magnesium (2.4.6.)...... 138 Materials based on plasticised poly(vinyl chloride) for Magnesium acetate tetrahydrate...... 3149 tubing used in sets for the transfusion of blood and blood Magnesium aluminium silicate...... 1799 components (3.3.3.)...... 468 Magnesium aluminometasilicate...... 3150 Materials for containers for human blood and blood Magnesium and alkaline-earth metals (2.4.7.)...... 139 components (3.3.1.)...... 465 dihydrate...... 3151 Materials used for the manufacture of containers (3.1.)...... 423 Magnesium carbonate, heavy...... 3153 Matricaria flower ...... 1529 Magnesium carbonate, light...... 3153 Matricaria liquid extract...... 1530 4.5-hydrate...... 3154 Matricaria oil...... 1531 Magnesium chloride hexahydrate ...... 3155 Meadowsweet ...... 1533 ...... 3155 Measles immunoglobulin, human...... 2859 Magnesium citrate dodecahydrate...... 3156 Measles, mumps and rubella vaccine (live)...... 1005 Magnesium citrate nonahydrate ...... 3157 Measles, mumps, rubella and varicella vaccine (live) ...... 1006 Magnesium fluoratum for homoeopathic preparations..... 1722 Measles vaccine (live)...... 1007 ...... 3157 Measurement and detection of radioactivity (2.2.66.) ...... 119 Measurement of consistency by penetrometry (2.9.9.)...... 337

General Notices (1) apply to all monographs and other texts 4279 Index EUROPEAN PHARMACOPOEIA 10.0

Mebendazole ...... 3180 Methanesulfonic acid, methyl, ethyl and isopropyl hydrochloride ...... 3181 methanesulfonate in (2.5.37.)...... 182 Meclozine dihydrochloride...... 3183 Methanesulfonyl chloride in methanesulfonic acid Medicated chewing gums ...... 907 (2.5.39.) ...... 184 Medicated chewing gums, dissolution test for (2.9.25.)...... 365 Methanol...... 3222 Medicated feeding stuffs for veterinary use, premixes for .. 927 Methanol and 2-propanol, test for (2.9.11.) ...... 342 Medicated foams...... 911 Methenamine ...... 3223 Medicated plasters ...... 936 Methionine ...... 3223 Medicated tampons ...... 940 Methionine ([11C]methyl) injection, L-...... 1220 Medicated vaginal tampons...... 941 Methionine, DL- ...... 3225 Medicinal air ...... 1768 Methods in pharmacognosy (2.8.)...... 305 Medicinal air, synthetic...... 1770 Methods of preparation of homoeopathic stocks and Medium-chain ...... 4096 potentisation ...... 1682 Medronic acid for radiopharmaceutical preparations ...... 1219 Methods of preparation of sterile products (5.1.1.) ...... 619 acetate...... 3184 ...... 3225 ...... 3186 Methyl, ethyl and isopropyl benzenesulfonate in active Mefloquine hydrochloride...... 3187 substances (2.5.41.)...... 186 acetate ...... 3189 Methyl, ethyl and isopropyl methanesulfonate in active Meglumine...... 3191 substances (2.5.38.)...... 183 Meldonium dihydrate...... 3192 Methyl, ethyl and isopropyl methanesulfonate in Melilot...... 1534 methanesulfonic acid (2.5.37.)...... 182 Melissa leaf ...... 1536 Methyl, ethyl and isopropyl toluenesulfonate in active Melissa leaf dry extract ...... 1537 substances (2.5.40.)...... 185 ...... 3193 Methyl methacrylate – methacrylic acid copolymer (1:1).. 3217 Melphalan ...... 3194 Methyl methacrylate - methacrylic acid copolymer (1:2).. 3218 Melting point - capillary method (2.2.14.) ...... 32 Methyl nicotinate...... 3228 Melting point - instantaneous method (2.2.16.)...... 33 Methyl parahydroxybenzoate...... 3229 Melting point - open capillary method (2.2.15.) ...... 33 Methyl parahydroxybenzoate, sodium...... 3830 ...... 3196 ...... 3230 Meningococcal group A, C, W135 and Y conjugate Methylcellulose ...... 3231 vaccine ...... 1009 ...... 3233 Meningococcal group C and haemophilus type b conjugate ...... 3250 vaccine ...... 979 Methylene chloride...... 3235 Meningococcal group C conjugate vaccine...... 1010 maleate ...... 3236 Meningococcal polysaccharide vaccine ...... 1012 Methylhydroxyethylcellulose...... 3237 , racemic...... 3197 Methylpentoses in polysaccharide vaccines (2.5.21.)...... 173 hydrochloride...... 3198 hydrochloride ...... 3238 ...... 3200 ...... 3239 maleate...... 3200 ...... 3240 Mercaptopurine ...... 3201 Methylprednisolone acetate...... 3243 Mercuric chloride ...... 3202 Methylprednisolone hydrogen succinate...... 3245 Mercury porosimetry, porosity and pore-size distribution of Methylpyrrolidone, N- ...... 3246 solids by (2.9.32.)...... 377 Methylrosanilinium chloride ...... 3247 Meropenem trihydrate...... 3203 ...... 3249 ...... 3204 Methylthioninium chloride hydrate...... 3250 ...... 3207 hydrochloride...... 3251 ...... 3208 ...... 3252 ...... 3209 Metoclopramide hydrochloride monohydrate...... 3253 Metabisulfite, potassium ...... 3607 Metolazone ...... 3255 Metabisulfite, sodium...... 3829 succinate...... 3256 Metacresol...... 3210 Metoprolol tartrate ...... 3258 Metal catalyst or metal reagent residues (5.20.)...... 815 ...... 3259 Metal catalyst or metal reagent residues, determination of ...... 3261 (2.4.20.) ...... 144 Metronidazole benzoate...... 3262 sodium monohydrate...... 3211 hydrochloride ...... 3263 Metered-dose preparations for inhalation, non- hydrochloride...... 3264 pressurised...... 930 ...... 3266 Metered-dose preparations for inhalation, pressurised...... 928 Miconazole nitrate...... 3267 hydrochloride...... 3213 Micro determination of water (2.5.32.)...... 178 Methacrylate copolymer, basic butylated ...... 1925 Microbial enumeration tests (microbiological examination of Methacrylic acid - ethyl acrylate copolymer (1:1)...... 3214 non-sterile products) (2.6.12.) ...... 201 Methacrylic acid - ethyl acrylate copolymer (1:1) dispersion Microbiological assay of antibiotics (2.7.2.) ...... 262 30 per cent...... 3216 Microbiological examination of cell-based preparations Methacrylic acid - methyl methacrylate copolymer (1:1).. 3217 (2.6.27.) ...... 231 Methacrylic acid - methyl methacrylate copolymer (1:2).. 3218 Microbiological examination of herbal medicinal products for hydrochloride ...... 3219 oral use and extracts used in their preparation (2.6.31.)... 239 Methane ...... 3220 Microbiological examination of live biotherapeutic Methane intermix (2 per cent) in nitrogen ...... 3221 products: tests for enumeration of microbial contaminants Methanesulfonate (methyl, ethyl and isopropyl) in active (2.6.36.) ...... 250 substances (2.5.38.)...... 183 Microbiological examination of live biotherapeutic products: Methanesulfonic acid, methanesulfonyl chloride in tests for specified micro-organisms (2.6.38.) ...... 255 (2.5.39.) ...... 184 Microbiological examination of non-sterile products: microbial enumeration tests (2.6.12.) ...... 201

4280 See the information section on general monographs (cover pages) EUROPEAN PHARMACOPOEIA 10.0 Index

Microbiological examination of non-sterile products: test for Mycoplasma gallisepticum vaccine (inactivated) ...... 1129 specified micro-organisms (2.6.13.) ...... 205 Mycoplasmas (2.6.7.)...... 194 Microbiological quality, alternative methods for control of myo-Inositol ...... 2944 (5.1.6.) ...... 628 Myrrh ...... 1546 Microbiological quality of herbal medicinal products for oral Myrrh tincture ...... 1547 use and extracts used in their preparation (5.1.8.)...... 638 Myxomatosis vaccine (live) for rabbits ...... 1131 Microbiological quality of non-sterile pharmaceutical preparations and substances for pharmaceutical use N (5.1.4.) ...... 627 ...... 3317 Microbiology, general texts on (5.1.) ...... 619 N-Acetyltryptophan ...... 1755 Microcalorimetry and solution calorimetry, characterisation N-Acetyltyrosine...... 1757 of crystalline solids by (2.2.61.) ...... 115 ...... 3318 Microcrystalline cellulose...... 2146 ...... 3319 Microcrystalline cellulose and carmellose sodium ...... 3269 hydrogen oxalate ...... 3322 Microscopic examination of herbal drugs (2.8.23) ...... 317 Nalidixic acid ...... 3323 Microscopy, optical (2.9.37.)...... 390 hydrochloride dihydrate...... 3325 Microscopy, scanning electron (2.9.52.)...... 414 hydrochloride...... 3327 ...... 3270 Names of herbal drugs used in traditional Chinese medicine for veterinary use ...... 3272 (5.22.) ...... 839 Milk thistle dry extract, refined and standardised ...... 1538 decanoate ...... 3328 Milk thistle fruit...... 1539 hydrochloride...... 3330 Minimising the risk of transmitting animal spongiform Naphazoline nitrate ...... 3331 encephalopathy agents via human and veterinary medicinal ...... 3333 products (5.2.8.)...... 661 Naproxen sodium ...... 3335 hydrochloride dihydrate...... 3275 Narrow-leaved coneflower root ...... 1548 ...... 3277 Nasal drops and liquid nasal sprays ...... 919 Mint oil, partly dementholised ...... 1541 Nasal powders ...... 920 ...... 3278 Nasal preparations...... 918 ...... 3279 Nasal preparations, semi-solid...... 920 Mites for allergen products ...... 3281 Nasal sprays (liquid) and nasal drops ...... 918 Mitomycin ...... 3282 Nasal sticks ...... 920 Mitoxantrone hydrochloride...... 3283 Nasal washes...... 920 Modafinil ...... 3285 ...... 3337 Modified-release capsules...... 907 Near-infrared spectroscopy (2.2.40.)...... 70 Modified-release granules...... 912 Nebulisation, characterisation of preparations for Modified-release tablets...... 939 (2.9.44.) ...... 404 Mofetil mycophenolate ...... 3312 Nebulisation, liquid preparations for...... 928 Molecular mass distribution in dextrans (2.2.39.)...... 68 Neohesperidin-dihydrochalcone ...... 3339 Molgramostim concentrated solution...... 3286 sulfate ...... 3340 ...... 3288 Neonatal piglet colibacillosis vaccine (inactivated)...... 1132 Molybdate dihydrate, sodium ...... 3831 Neonatal ruminant colibacillosis vaccine (inactivated)..... 1133 furoate...... 3290 Neostigmine bromide...... 3342 Mometasone furoate monohydrate ...... 3293 Neostigmine metilsulfate...... 3343 Monoclonal antibodies for human use ...... 878 Neroli oil...... 1550 Monocyte-activation test (2.6.30.)...... 233 sulfate...... 3344 Monographs on herbal drug extracts (information chapter) Nettle leaf...... 1551 (5.23.) ...... 843 ′ Nettle root...... 1553 Monophosphoryl lipid A, 3-O-desacyl-4 - ...... 2355 Neurovirulence test of live viral vaccines (2.6.18.)...... 218 sodium...... 3295 ...... 3346 hydrogen tartrate for veterinary use ...... 3298 Nevirapine hemihydrate ...... 3347 hydrochloride ...... 3299 Newcastle disease vaccine (inactivated)...... 1134 Morphine sulfate...... 3300 Newcastle disease vaccine (live)...... 1136 Moss, Iceland...... 1480 Niaouli oil, cineole type ...... 1554 Mother tinctures for homoeopathic preparations...... 1681 hydrochloride ...... 3348 Motherwort ...... 1542 ...... 3349 Moulds for allergen products...... 3302 Nickel in hydrogenated vegetable oils (2.4.31.) ...... 163 Moutan bark...... 1543 Nickel in polyols (2.4.15.)...... 143 ...... 921 ...... 3351 for veterinary use...... 3303 Niclosamide monohydrate ...... 3352 Moxifloxacin hydrochloride...... 3306 ...... 3353 Moxonidine ...... 3308 ...... 3354 Mucoadhesive preparations...... 922 ...... 3355 Mullein flower...... 1545 Nicotine ditartrate dihydrate...... 3356 Multidose containers, uniformity of mass of delivered doses Nicotine resinate...... 3357 (2.9.27.) ...... 372 Nicotinic acid ...... 3359 Mumps, measles and rubella vaccine (live)...... 1005 ...... 3360 Mumps, measles, rubella and varicella vaccine (live) ...... 1006 Niflumic acid...... 3362 Mumps vaccine (live) ...... 1014 Nifuroxazide...... 3363 Mupirocin...... 3309 Nikethamide...... 3364 Mupirocin calcium ...... 3310 Nilotinib hydrochloride monohydrate...... 3365 Mycobacteria (2.6.2.)...... 194 ...... 3367 Mycophenolate mofetil ...... 3312 ...... 3368 Mycophenolate sodium...... 3314

General Notices (1) apply to all monographs and other texts 4281 Index EUROPEAN PHARMACOPOEIA 10.0

Nimodipine ...... 3369 Oils, fatty, identification by thin-layer chromatography ...... 3371 (2.3.2.) ...... 132 ...... 3372 Oils, fatty, vegetable...... 901 Nitric acid...... 3373 Oils rich in omega-3 acids, composition of fatty acids in ...... 3373 (2.4.29.) ...... 161 Nitrofural...... 3374 Oils rich in omega-3 acids, total cholesterol in (2.4.32.) ..... 163 Nitrofurantoin...... 3375 Ointments...... 936 Nitrogen...... 3376 ...... 3410 Nitrogen determination by sulfuric acid digestion (2.5.9.).. 170 ...... 3411 Nitrogen determination, primary aromatic amino (2.5.8.).. 169 Oleoresins ...... 868 Nitrogen, low-oxygen...... 3377 Oleoyl macrogolglycerides ...... 3411 Nitrogen monoxide and nitrogen dioxide in gases ...... 3412 (2.5.26.) ...... 176 Olive leaf...... 1557 Nitroprusside, sodium ...... 3832 Olive leaf dry extract...... 1559 Nitrous oxide...... 3377 Olive oil, refined ...... 3413 Nitrous oxide in gases (2.5.35.)...... 182 Olive oil, virgin ...... 3414 Nizatidine ...... 3379 Olmesartan medoxomil ...... 3415 N-Methylpyrrolidone ...... 3246 Olsalazine sodium ...... 3417 NMR spectrometry (2.2.33.) ...... 58 Omega-3 acids, composition of fatty acids in oils rich in NMR spectrometry, peptide identification by (2.2.64.)...... 118 (2.4.29.) ...... 161 N,N-Dimethylaniline (2.4.26.) ...... 158 Omega-3 acids, fish oil rich in ...... 2639 acetate ...... 3381 Omega-3 acids, total cholesterol in oils rich in (2.4.32.) ..... 163 Nonoxinol 9...... 3381 Omega-3-acid ethyl esters 60 ...... 3419 Non-sterile pharmaceutical preparations and substances for Omega-3-acid ethyl esters 90 ...... 3421 pharmaceutical use, microbiological quality of (5.1.4.)..... 627 Omega-3-acid triglycerides ...... 3423 Non-sterile products, microbiological examination of ...... 3425 (microbial enumeration tests) (2.6.12.) ...... 201 Omeprazole magnesium...... 3427 Non-sterile products, microbiological examination of (test for Omeprazole sodium...... 3428 specified micro-organisms) (2.6.13.)...... 205 hydrochloride dihydrate ...... 3430 Noradrenaline hydrochloride...... 3382 Opalescence of liquids, clarity and degree of (2.2.1.)...... 21 Noradrenaline tartrate ...... 3384 Ophthalmic inserts...... 910 hydrochloride ...... 3382 dry extract, standardised...... 1560 Norepinephrine tartrate...... 3384 Opium, prepared ...... 1561 ...... 3385 Opium, raw...... 1562 ...... 3387 Opium tincture, standardised ...... 1564 Norfloxacin...... 3388 Optical microscopy (2.9.37.) ...... 390 Norflurane ...... 3390 Optical rotation (2.2.7.) ...... 26 ...... 3396 Oral drops...... 918 ...... 3397 Oral lyophilisates ...... 939 Normal immunoglobulin for intramuscular administration, Oral powders...... 926 human ...... 2860 Oral solutions, emulsions and suspensions...... 917 Normal immunoglobulin for intravenous administration, Oral use, liquid preparations for ...... 916 human ...... 2862 Oral use, veterinary semi-solid preparations for...... 942 Normal immunoglobulin for subcutaneous administration, Orbifloxacin for veterinary use...... 3431 human ...... 2864 sulfate...... 3433 hydrochloride...... 3397 Oregano ...... 1565 ...... 3399 Organ preservation, solutions for...... 3852 Noscapine hydrochloride hydrate...... 3400 Oriental cashew for homoeopathic preparations ...... 1702 Notoginseng root...... 1555 Orientvine stem ...... 1567 Nuclear magnetic resonance spectrometry (2.2.33.)...... 58 Orodispersible films ...... 922 Nuclear magnetic resonance spectrometry, peptide Orodispersible tablets ...... 939 identification by (2.2.64.)...... 118 Oromucosal capsules...... 922 Nucleated cell count and viability (2.7.29.) ...... 297 Oromucosal drops, oromucosal sprays and sublingual Nucleic acid amplification techniques (2.6.21.) ...... 219 sprays...... 921 Nucleic acids in polysaccharide vaccines (2.5.17.) ...... 172 Oromucosal preparations ...... 920 Numeration of CD34/CD45+ cells in haematopoietic products Oromucosal preparations, semi-solid ...... 921 (2.7.23.) ...... 292 Oromucosal solutions and oromucosal suspensions...... 921 Nutmeg oil...... 1556 Oromucosal sprays, oromucosal drops and sublingual Nux-vomica for homoeopathic preparations...... 1723 sprays...... 920 ...... 3401 Oromucosal suspensions and oromucosal solutions...... 920 citrate...... 3434 O Orphenadrine hydrochloride...... 3436 O-Acetyl in polysaccharide vaccines (2.5.19.)...... 173 phosphate ...... 3437 Oak bark ...... 1557 Osmolality (2.2.35.) ...... 63 Octoxinol 10...... 3405 ...... 3439 ...... 3405 Oxacillin sodium monohydrate ...... 3440 Octyl gallate...... 3407 Oxaliplatin...... 3442 Octyldodecanol...... 3407 ...... 3445 Odour (2.3.4.)...... 133 ...... 3446 Odour and taste of essential oils (2.8.8.)...... 306 hydrogen citrate ...... 3448 Ofloxacin...... 3408 for veterinary use...... 3449 Oils, essential...... 864 Oxidising substances (2.5.30.)...... 177 Oxitropium bromide ...... 3450

4282 See the information section on general monographs (cover pages) EUROPEAN PHARMACOPOEIA 10.0 Index

Oxolinic acid ...... 3451 Particulate contamination: visible particles (2.9.20.)...... 362 hydrochloride ...... 3453 Parvovirosis vaccine (inactivated), canine...... 1085 hydrochloride...... 3454 Parvovirosis vaccine (inactivated), porcine...... 1143 hydrochloride...... 3455 Parvovirosis vaccine (live), canine...... 1086 Oxygen ...... 3456 Passion flower ...... 1570 Oxygen (15O) ...... 1222 Passion flower dry extract ...... 1571 Oxygen (93 per cent)...... 3457 Pastes...... 936 Oxygen in gases (2.5.27.) ...... 176 Pasteurella vaccine (inactivated) for sheep...... 1138 Oxygen-flask method (2.5.10.)...... 170 Pastilles and lozenges ...... 922 hydrochloride...... 3459 Patches, cutaneous...... 935 dihydrate...... 3460 Patches, transdermal ...... 925 Oxytetracycline hydrochloride...... 3462 Patches, transdermal, dissolution test for (2.9.4.)...... 333 ...... 3464 Pea starch...... 3492 Oxytocin concentrated solution...... 3465 Pefloxacin mesilate dihydrate...... 3493 Pelargonium root...... 1571 P disodium heptahydrate...... 3494 ...... 3469 sulfate ...... 3497 Pale coneflower root...... 1568 Penetrometry, measurement of consistency by (2.9.9.)...... 337 Palmitic acid...... 3473 ...... 3498 Pamidronate disodium pentahydrate...... 3474 Penicillin G (benzathine) tetrahydrate...... 1951 powder...... 3474 Penicillin G potassium...... 1953 Pancreatic necrosis vaccine (inactivated, oil-adjuvanted, Penicillin G (procaine) monohydrate ...... 1955 injectable) for salmonids, infectious ...... 1124 Penicillin G sodium...... 1957 ...... 3477 Penicillin V...... 3530 Panleucopenia vaccine (inactivated), feline ...... 1109 Penicillin V (benzathine) tetrahydrate...... 3531 Panleucopenia vaccine (live), feline ...... 1110 Penicillin V potassium...... 3533 Pansy, wild (flowering aerial parts)...... 1668 Pentaerythrityl tetranitrate, diluted...... 3499 Pantoprazole sodium sesquihydrate...... 3478 diisetionate ...... 3501 Pantothenate, calcium...... 2063 ...... 3502 hydrochloride...... 3480 Pentazocine hydrochloride...... 3502 Paper chromatography (2.2.26.) ...... 46 Pentazocine lactate ...... 3503 Papillomavirus vaccine (rDNA), human ...... 989 Pentetate sodium calcium for radiopharmaceutical , butyl ...... 2025 preparations ...... 1223 Paraben, ethyl...... 2583 ...... 3504 Paraben, methyl ...... 3229 Pentobarbital sodium...... 3505 Paraben, propyl...... 3660 ...... 3507 Paraben, sodium ethyl...... 3816 hydrogen citrate ...... 3509 Paraben, sodium methyl...... 3830 Peony root, red...... 1572 Paraben, sodium propyl...... 3838 Peony root, white...... 1573 ...... 3481 Pepper ...... 1575 Paraffin, hard...... 3483 Pepper, long...... 1510 Paraffin, light liquid ...... 3483 Peppermint leaf...... 1577 Paraffin, liquid ...... 3484 Peppermint leaf dry extract...... 1578 Paraffin, white soft...... 3485 Peppermint oil ...... 1579 Paraffin, yellow soft ...... 3486 Pepsin powder...... 3509 Parahydroxybenzoate, butyl ...... 2025 Peptide identification by nuclear magnetic resonance Parahydroxybenzoate, ethyl ...... 2583 spectrometry (2.2.64.)...... 118 Parahydroxybenzoate, methyl...... 3229 Peptide mapping (2.2.55.)...... 97 Parahydroxybenzoate, propyl...... 3660 Peptides, synthetic, acetic acid in (2.5.34.)...... 181 Parahydroxybenzoate, sodium ethyl ...... 3816 Perborate, hydrated sodium ...... 3833 Parahydroxybenzoate, sodium methyl...... 3830 mesilate...... 3511 Parahydroxybenzoate, sodium propyl...... 3838 Perindopril tert-butylamine ...... 3512 Parainfluenza virus vaccine (live), bovine ...... 1073 Peritoneal dialysis, solutions for ...... 3515 Parainfluenza virus vaccine (live), canine ...... 1084 (25:75) ...... 3517 ...... 3486 Peroxide value (2.5.5.)...... 168 Paramyxovirus 1 (Newcastle disease) vaccine (inactivated), ...... 3519 avian ...... 1134 Pertussis (acellular, component), diphtheria and tetanus Paramyxovirus 1 (Newcastle disease) vaccine (live), vaccine (adsorbed) ...... 955 avian ...... 1136 Pertussis (acellular, component), diphtheria and tetanus Paramyxovirus 3 vaccine (inactivated) for turkeys, avian.. 1068 vaccine (adsorbed, reduced antigen(s) content)...... 956 Parenteral preparations...... 923 Pertussis (acellular, component), diphtheria, tetanus and Parenteral preparations, test for extractable volume of haemophilus type b conjugate vaccine (adsorbed) ...... 961 (2.9.17.) ...... 347 Pertussis (acellular, component), diphtheria, tetanus and ...... 3487 hepatitis B (rDNA) vaccine (adsorbed) ...... 963 hydrochloride ...... 3488 Pertussis (acellular, component), diphtheria, tetanus and Paroxetine hydrochloride hemihydrate ...... 3490 poliomyelitis (inactivated) vaccine (adsorbed)...... 964 Particle size analysis by laser light diffraction (2.9.31.)...... 373 Pertussis (acellular, component), diphtheria, tetanus and Particles, fine, aerodynamic assessment of in preparations for poliomyelitis (inactivated) vaccine (adsorbed, reduced inhalation (2.9.18.) ...... 347 antigen(s) content) ...... 966 Particle-size distribution estimation by analytical sieving Pertussis (acellular, component), diphtheria, tetanus, (2.9.38.) ...... 392 hepatitis B (rDNA), poliomyelitis (inactivated) and Particulate contamination: sub-visible particles (2.9.19.) ... 360 haemophilus type b conjugate vaccine (adsorbed) ...... 968

General Notices (1) apply to all monographs and other texts 4283 Index EUROPEAN PHARMACOPOEIA 10.0

Pertussis (acellular, component), diphtheria, tetanus, Pillules, homoeopathic, coated ...... 1697 poliomyelitis (inactivated) and haemophilus type b conjugate Pillules, homoeopathic, impregnated...... 1697 vaccine (adsorbed) ...... 970 Pilocarpine hydrochloride...... 3559 Pertussis toxin (residual) (2.6.33.)...... 241 Pilocarpine nitrate ...... 3560 Pertussis vaccine (acellular), assay of (2.7.16.)...... 286 for veterinary use...... 3561 Pertussis vaccine (acellular, component, adsorbed)...... 1015 ...... 3562 Pertussis vaccine (acellular, co-purified, adsorbed) ...... 1016 ...... 3563 Pertussis vaccine (whole cell, adsorbed)...... 1018 Pine (dwarf) oil...... 1419 Pertussis vaccine (whole cell), assay of (2.7.7.) ...... 274 Pine sylvestris oil ...... 1581 Pertussis (whole cell), diphtheria and tetanus vaccine Pioglitazone hydrochloride ...... 3565 (adsorbed) ...... 958 Pipemidic acid trihydrate ...... 3566 Pertussis(wholecell),diphtheria,tetanusandpoliomyelitis Piperacillin...... 3567 (inactivated) vaccine (adsorbed) ...... 973 Piperacillin sodium ...... 3568 Pertussis (whole cell), diphtheria, tetanus, poliomyelitis adipate ...... 3570 (inactivated) and haemophilus type b conjugate vaccine Piperazine citrate ...... 3571 (adsorbed) ...... 974 Piperazine hydrate...... 3572 Peru balsam ...... 1580 ...... 3573 Pessaries ...... 940 dihydrochloride monohydrate ...... 3574 Pessaries and suppositories, disintegration of (2.9.2.) ...... 325 ...... 3575 Pesticide residues (2.8.13.)...... 308 Pirfenidone...... 3576 hydrochloride ...... 3520 ...... 3577 Petroleum rectificatum for homoeopathic preparations ... 1725 Pivampicillin ...... 3579 pH of solutions, approximate (2.2.4.)...... 25 Pivmecillinam hydrochloride...... 3581 pH, potentiometric determination of (2.2.3.) ...... 24 Plasma for fractionation, human...... 2865 Pharmaceutical preparations...... 880 Plasma (pooled and treated for virus inactivation), Pharmaceutical technical procedures (2.9.) ...... 323 human ...... 2867 Pharmacognosy, methods in (2.8.)...... 305 Plasmid vectors for human use, bacterial cells used for the Pharmacopoeial harmonisation (5.8.) ...... 755 manufacture of...... 781 ...... 3522 Plasmin inhibitor, assay of human (2.7.25.)...... 295 maleate...... 3523 Plasters, medicated ...... 935 ...... 3524 Plastic additives (3.1.13.) ...... 441 Phenobarbital sodium...... 3525 Plastic containers and closures for pharmaceutical use Phenol ...... 3527 (3.2.2.) ...... 459 Phenol in immunosera and vaccines (2.5.15.) ...... 172 Plastic containers for aqueous solutions for infusion ...... 3527 (3.2.2.1.) ...... 460 Phenolsulfonphthalein ...... 3528 Plastic containers for human blood and blood components, Phenothiazines, identification by thin-layer chromatography sterile (3.3.4.)...... 471 (2.3.3.) ...... 133 Plastic syringes, single-use, sterile (3.3.8.)...... 477 ...... 3529 Platycodon root...... 1582 Phenoxymethylpenicillin...... 3530 Pneumococcal polysaccharide conjugate vaccine Phenoxymethylpenicillin (benzathine) tetrahydrate...... 3531 (adsorbed) ...... 1019 Phenoxymethylpenicillin potassium ...... 3533 Pneumococcal polysaccharide vaccine ...... 1021 mesilate...... 3535 Pneumonia vaccine (inactivated), porcine enzootic ...... 1141 ...... 3536 ...... 3582 ...... 3538 Poliomyelitis (inactivated), diphtheria and tetanus vaccine Phenylbutyrate, sodium ...... 3833 (adsorbed, reduced antigen(s) content)...... 959 ...... 3539 Poliomyelitis (inactivated), diphtheria, tetanus and pertussis Phenylephrine hydrochloride...... 3541 (acellular, component) vaccine (adsorbed)...... 964 Phenylmercuric acetate...... 3542 Poliomyelitis (inactivated), diphtheria, tetanus and pertussis ...... 3542 (acellular, component) vaccine (adsorbed, reduced antigen(s) Phenylmercuric nitrate ...... 3543 content)...... 966 hydrochloride ...... 3543 Poliomyelitis (inactivated), diphtheria, tetanus and pertussis ...... 3545 (whole cell) vaccine (adsorbed)...... 973 Phenytoin sodium...... 3546 Poliomyelitis (inactivated), diphtheria, tetanus, pertussis ...... 3548 (acellular, component) and haemophilus type b conjugate Phloroglucinol dihydrate ...... 3549 vaccine (adsorbed) ...... 970 monohydrate ...... 3551 Poliomyelitis (inactivated), diphtheria, tetanus, pertussis Phosphates (2.4.11.)...... 142 (acellular, component), hepatitis B (rDNA) and haemophilus Phospholipids for injection, egg ...... 2494 type b conjugate vaccine (adsorbed)...... 968 Phospholipids for injection, soya...... 3870 Poliomyelitis (inactivated), diphtheria, tetanus, pertussis , concentrated...... 3553 (whole cell) and haemophilus type b conjugate vaccine Phosphoric acid, dilute ...... 3553 (adsorbed) ...... 974 Phosphorus in polysaccharide vaccines (2.5.18.) ...... 172 Poliomyelitis vaccine (inactivated)...... 1023 Phthalylsulfathiazole ...... 3553 Poliomyelitis vaccine (inactivated), in vivo assay of Physical and physico-chemical methods (2.2.)...... 21 (2.7.20.) ...... 289 salicylate ...... 3554 Poliomyelitis vaccine (oral) ...... 1026 , racemic ...... 3555 Pollens for allergen products...... 3583 Phytonadione, racemic...... 3555 Poloxamers ...... 3584 ...... 3557 Polyacrylate dispersion 30 per cent...... 3586 Picosulfate, sodium ...... 3835 Polyamide suture, sterile, in distributor for veterinary monohydrate...... 3558 use...... 1282 Piglet colibacillosis vaccine (inactivated), neonatal ...... 1132 Poly(ethylene - vinyl acetate) for containers and tubing for Pillules for homoeopathic preparations...... 1696 total parenteral nutrition preparations (3.1.7.)...... 434

4284 See the information section on general monographs (cover pages) EUROPEAN PHARMACOPOEIA 10.0 Index

Polyethylene oxides, high-molecular-mass ...... 3147 Porosity and pore-size distribution of solids by mercury Polyethylene terephthalate for containers for preparations not porosimetry (2.9.32.)...... 377 for parenteral use (3.1.15.) ...... 448 Porosity of sintered-glass filters (2.1.2.)...... 15 Poly(ethylene terephthalate) suture, sterile, in distributor for Porous solids including powders, wettability of (2.9.45.).... 406 veterinary use...... 1283 Potassium (2.4.12.) ...... 142 Polyethylene with additives for containers for parenteral ...... 3596 preparations and for ophthalmic preparations (3.1.5.)...... 427 ...... 3597 Polyethylene without additives for containers for parenteral Potassium carbonate...... 3598 preparations and for ophthalmic preparations (3.1.4.)...... 426 Potassium chloride ...... 3598 Polyethyleneglycols...... 3145 ...... 3599 Polyethyleneglycols, high-molecular-mass...... 3147 Potassium clavulanate ...... 3599 Polygonum cuspidatum rhizome and root...... 1583 Potassium clavulanate, diluted...... 3602 Polygonum orientale fruit ...... 1585 Potassium dichromate for homoeopathic preparations..... 1721 Polymorphism (5.9.)...... 759 Potassium dihydrogen phosphate...... 3603 sulfate...... 3587 Potassium disulfite...... 3607 Polyolefins (3.1.3.) ...... 423 Potassium hydrogen aspartate hemihydrate ...... 3604 Polyoxyl castor oil...... 3144 Potassium hydrogen carbonate...... 3605 Polyoxyl hydrogenated castor oil...... 3144 Potassium hydrogen tartrate ...... 3605 Polyoxypropylene stearyl ether...... 3588 ...... 3606 Polypropylene for containers and closures for parenteral ...... 3606 preparations and ophthalmic preparations (3.1.6.)...... 431 Potassium metabisulfite ...... 3607 Polysaccharide vaccines for human use, conjugated, carrier Potassium nitrate ...... 3607 proteins for the production of (5.2.11.) ...... 674 Potassium ...... 3608 Polysaccharide vaccines, hexosamines in (2.5.20.)...... 173 ...... 3609 Polysaccharide vaccines, methylpentoses in (2.5.21.) ...... 173 Potassium tetrahydrate ...... 3609 Polysaccharide vaccines, nucleic acids in (2.5.17.)...... 172 Potassium sorbate...... 3610 Polysaccharide vaccines, O-acetyl in (2.5.19.)...... 173 Potassium sulfate ...... 3610 Polysaccharide vaccines, phosphorus in (2.5.18.)...... 172 Potato starch...... 3611 Polysaccharide vaccines, protein in (2.5.16.)...... 172 Potentiometric determination of ionic concentration using Polysaccharide vaccines, ribose in (2.5.31.) ...... 177 ion-selective electrodes (2.2.36.)...... 64 Polysaccharide vaccines, sialic acid in (2.5.23.) ...... 174 Potentiometric determination of pH (2.2.3.) ...... 24 Polysaccharide vaccines, uronic acids in (2.5.22.)...... 174 Potentiometric titration (2.2.20.)...... 35 Polysorbate 20 ...... 3589 Potentisation, methods of preparation of homoeopathic stocks Polysorbate 40 ...... 3590 and...... 1682 Polysorbate 60 ...... 3591 Poultices...... 936 Polysorbate 80 ...... 3591 Pour-on preparations ...... 942 sulfonate, sodium ...... 3836 Povidone ...... 3612 Poly(vinyl acetate) ...... 3593 Povidone, iodinated...... 3615 Poly(vinyl acetate) dispersion 30 per cent...... 3594 Powder fineness (2.9.35.) ...... 387 Poly(vinyl alcohol)...... 3595 Powder flow (2.9.36.)...... 387 Poly(vinyl alcohol) macrogol grafted copolymer ...... 3140 Powder flow properties by shear cell methods (2.9.49.) ...... 411 Poly(vinyl chloride) (non-plasticised) for containers for solid Powdered cellulose ...... 2150 dosage forms for oral administration, materials based on Powders and granules for oral solutions and suspensions .. 917 (3.1.11.) ...... 439 Powders and granules for syrups...... 918 Poly(vinyl chloride), non-plasticised, materials based on for Powdersandtabletsforrectalsolutionsandsuspensions...934 containers for non-injectable aqueous solutions (3.1.10.).. 437 Powders, bulk density and tapped density of (2.9.34.)...... 384 Poly(vinyl chloride), plasticised, empty sterile containers of, Powders, ear ...... 909 for human blood and blood components (3.3.5.) ...... 473 Powders, effervescent ...... 927 Poly(vinyl chloride), plasticised, materials based on, for Powders for cutaneous application...... 925 containers for aqueous solutions for intravenous infusion Powders for eye drops and powders for eye lotions...... 910 (3.1.14.) ...... 445 Powders for injections or infusions...... 924 Poly(vinyl chloride), plasticised, materials based on, for Powders for oral drops...... 918 containers for human blood and blood components Powders, inhalation...... 931 (3.3.2.) ...... 465 Powders, nasal...... 920 Poly(vinyl chloride), plasticised, materials based on, for Powders, oral...... 926 tubing used in sets for the transfusion of blood and blood Powders, wettability of porous solids including (2.9.45.).... 406 components (3.3.3.)...... 468 dihydrochloride monohydrate ...... 3615 Poly(vinyl chloride), plasticised, sterile containers of, for hydrochloride...... 3617 human blood containing anticoagulant solution (3.3.6.) .. 474 Pravastatin sodium...... 3618 Poppy petals, red...... 1595 ...... 3620 Porcine actinobacillosis vaccine (inactivated) ...... 1139 ...... 3621 Porcine enzootic pneumonia vaccine (inactivated) ...... 1141 hydrochloride...... 3622 Porcine influenza vaccine (inactivated) ...... 1142 Precursors for radiopharmaceutical preparations, Porcine insulin ...... 2957 chemical...... 863 Porcine parvovirosis vaccine (inactivated)...... 1143 ...... 3624 Porcine progressive atrophic rhinitis vaccine ...... 3625 (inactivated) ...... 1144 ...... 3627 Pore-size distribution of solids by mercury porosimetry, Prednisolone pivalate ...... 3629 porosity and (2.9.32.) ...... 377 Prednisolone sodium phosphate...... 3630 Poria ...... 1587 ...... 3631 Porosimetry, mercury, porosity and pore-size distribution of ...... 3633 solids by (2.9.32.)...... 377 Pregelatinised hydroxypropyl starch...... 3890 Pregelatinised starch...... 3891

General Notices (1) apply to all monographs and other texts 4285 Index EUROPEAN PHARMACOPOEIA 10.0

Prekallikrein activator (2.6.15.)...... 213 Pycnometric density of solids, gas (2.9.23.) ...... 364 Premixes for medicated feeding stuffs for veterinary use ... 927 Pygeum africanum bark ...... 1593 Preparations for inhalation ...... 927 embonate...... 3673 Preparations for inhalation: aerodynamic assessment of fine Pyrazinamide ...... 3674 particles (2.9.18.) ...... 347 Pyridostigmine bromide...... 3675 Preparations for irrigation...... 932 hydrochloride...... 3676 Preparations for nebulisation: characterisation (2.9.44.) .... 404 Pyrimethamine ...... 3677 Preservative and anticoagulant solutions for human Pyrogens (2.6.8.) ...... 199 blood ...... 1856 (sodium) decahydrate for radiopharmaceutical Pressurised pharmaceutical preparations...... 933 preparations ...... 1241 ...... 3635 Pyrrolidone...... 3678 Prilocaine hydrochloride ...... 3636 Primaquine diphosphate...... 3637 Q Primary aromatic amino-nitrogen, determination of Quality control of vaccines, substitution of in vivo method(s) (2.5.8.) ...... 169 by in vitro method(s) for the (5.2.14.) ...... 679 Primary standards for volumetric solutions (4.2.1.) ...... 609 Quality of non-sterile pharmaceutical preparations and ...... 3639 substances for pharmaceutical use, microbiological Primula root ...... 1588 (5.1.4.) ...... 627 Probenecid...... 3640 Quantification and characterisation of residual host-cell DNA hydrochloride...... 3641 (2.6.35.) ...... 248 Procaine benzylpenicillin monohydrate...... 1955 Quantified hawthorn leaf and flower liquid extract...... 1473 Procaine hydrochloride...... 3642 fumarate ...... 3683 Procaine penicillin G monohydrate ...... 1955 Quillaia bark...... 1593 Process analytical technology (5.25.) ...... 855 Quinapril hydrochloride...... 3685 maleate...... 3642 sulfate ...... 3687 Products of fermentation...... 882 hydrochloride ...... 3689 Products of recombinant DNA technology...... 888 Quinine sulfate...... 3690 Products with risk of transmitting agents of animal spongiform encephalopathies ...... 884 R Progenitor cells, human haematopoietic, colony-forming cell assay for (2.7.28.)...... 296 Rabbit haemorrhagic disease vaccine (inactivated) ...... 1147 ...... 3644 Rabeprazole sodium...... 3695 Progressive atrophic rhinitis vaccine (inactivated), Rabeprazole sodium hydrate...... 3696 porcine ...... 1144 Rabies immunoglobulin, human ...... 2871 Proguanil hydrochloride...... 3646 Rabies vaccine for human use prepared in cell cultures.... 1030 ...... 3647 Rabies vaccine (inactivated) for veterinary use ...... 1148 hydrochloride ...... 3649 Rabies vaccine (live, oral) for foxes and raccoon dogs ...... 1150 hydrochloride...... 3649 ...... 3698 hydrochloride...... 3651 Racementhol...... 3197 hydrochloride...... 3652 Racemic camphor ...... 2069 Propanol...... 3654 Racemic ephedrine hydrochloride ...... 2513 Propanol and methanol, 2-, test for (2.9.11.) ...... 342 Racemic menthol...... 3197 Racephedrine hydrochloride...... 2513 ...... 3655 11 ...... 3656 ([ C]methoxy) injection...... 1224 hydrochloride...... 3658 Radioactivity, detection and measurement of (2.2.66.) ...... 119 Radiolabelling, fluoride (18F) solution for ...... 1194 Propyl gallate...... 3659 68 Propyl parahydroxybenzoate...... 3660 Radiolabelling, gallium ( Ga) chloride solution for...... 1206 Radiolabelling, lutetium (177Lu) solution for...... 1218 Propyl parahydroxybenzoate, sodium ...... 3838 123 Propylene glycol...... 3661 Radiolabelling, sodium iodide ( I) solution for...... 1228 Radiolabelling, sodium iodide (131I) solution for...... 1232 Propylene glycol dicaprylocaprate...... 3662 90 Propylene glycol dilaurate ...... 3662 Radiolabelling, yttrium ( Y) chloride solution for ...... 1265 Propylene glycol monolaurate...... 3663 Radionuclides, table of physical characteristics (5.7.)...... 745 Propylene glycol monopalmitostearate...... 3664 Radiopharmaceutical preparations ...... 884 Propylene glycol monostearate ...... 3664 Radiopharmaceutical preparations, chemical precursors ...... 3665 for ...... 863 ...... 3666 Radiopharmaceutical preparations, copper tetramibi sulfate...... 3667 tetrafluoroborate for...... 1187 Protein assays, host-cell (2.6.34.)...... 244 Radiopharmaceutical preparations, iobenguane sulfate Protein C, human, assay of (2.7.30.)...... 299 for ...... 1216 Protein in polysaccharide vaccines (2.5.16.) ...... 172 Radiopharmaceutical preparations, medronic acid for ..... 1219 Protein S, human, assay of (2.7.31.) ...... 300 Radiopharmaceutical preparations, pentetate sodium calcium Protein, total (2.5.33.) ...... 178 for ...... 1223 Prothrombin complex, human...... 2870 Radiopharmaceutical preparations, sodium iodohippurate Protirelin...... 3669 dihydrate for...... 1234 ...... 3670 Radiopharmaceutical preparations, sodium pyrophosphate hydrochloride...... 3671 decahydrate for ...... 1241 seed...... 1588 Radiopharmaceutical preparations, tetra-O-acetyl-mannose Pullulan...... 3672 triflate for ...... 1261 Pulsed electrochemical detection and direct amperometric Radiopharmaceuticals, extemporaneous preparation of detection (2.2.63.)...... 117 (5.19.) ...... 807 Purified water...... 4207 hydrochloride ...... 3699 Purple coneflower herb...... 1589 chewable tablets...... 3702 Purple coneflower root ...... 1591 Raltegravir potassium ...... 3701

4286 See the information section on general monographs (cover pages) EUROPEAN PHARMACOPOEIA 10.0 Index

Raltegravir tablets...... 3704 Roselle ...... 1600 Raman spectroscopy (2.2.48.) ...... 92 Rosemary leaf...... 1601 Ramipril...... 3705 Rosemary oil ...... 1603 Ramon assay, flocculation value (Lf) of diphtheria and tetanus calcium...... 3746 toxins and toxoids (2.7.27.) ...... 295 Rotating viscometer method - viscosity (2.2.10.) ...... 28 Ranitidine hydrochloride...... 3708 Rotation, optical (2.2.7.) ...... 26 Rapeseed oil, refined ...... 3709 Rotavirus diarrhoea vaccine (inactivated), calf ...... 1078 Raw materials of biological origin for the production of Rotavirus vaccine (live, oral)...... 1033 cell-based and gene therapy medicinal products (5.2.12.).. 675 ...... 3748 Reagents (4.)...... 481 Round amomum fruit...... 1604 Reagents (4.1.1.)...... 481 ...... 3750 Reagents, standard solutions, buffer solutions (4.1.) ...... 481 RRR-α-Tocopherol...... 4058 Recombinant DNA technology, products of...... 888 RRR-α-Tocopheryl acetate...... 4060 Recombinant vectors ...... 779 RRR-α-Tocopheryl hydrogen succinate ...... 4064 Recommendations on dissolution testing (5.17.1.) ...... 801 Rubber closures for containers for aqueous parenteral Recommendations on methods for dosage forms testing preparations, for powders and for freeze-dried powders (5.17.) ...... 801 (3.2.9.) ...... 460 Rectal capsules ...... 934 Rubella immunoglobulin, human ...... 2872 Rectal foams ...... 935 Rubella, measles and mumps vaccine (live) ...... 1005 Rectal preparations...... 933 Rubella, measles, mumps and varicella vaccine (live)...... 1006 Rectal preparations, semi-solid...... 935 Rubella vaccine (live) ...... 1035 Rectal solutions and suspensions, powders and tablets for.. 933 Ruminant colibacillosis vaccine (inactivated), neonatal.... 1133 Rectal solutions, emulsions and suspensions...... 934 Rupatadine fumarate...... 3752 Rectal tampons...... 935 Rutoside trihydrate...... 3753 Red peony root...... 1572 Red poppy petals...... 1595 S Reference standards (5.12.) ...... 773 ...... 3759 Refractive index (2.2.6.)...... 26 Saccharin sodium ...... 3760 Regorafenib monohydrate ...... 3710 Safety, viral (5.1.7.)...... 637 Relative density (2.2.5.)...... 25 Safflower flower ...... 1606 hydrochloride ...... 3711 Safflower oil, refined...... 3761 ...... 3714 for homoeopathic preparations...... 1710 ...... 3715 Sage leaf (Salvia officinalis) ...... 1607 Residual pertussis toxin (2.6.33.)...... 241 Sage leaf, three-lobed ...... 1608 Residual solvents (5.4.) ...... 717 Sage oil, Spanish...... 1629 Residual solvents, identification and control (2.4.24.)...... 152 Sage tincture...... 1609 Residue on evaporation of essential oils (2.8.9.)...... 306 ...... 3761 Residues, pesticide (2.8.13.)...... 308 Salbutamol sulfate...... 3764 Resistance to crushing of tablets (2.9.8.) ...... 337 ...... 3766 Resorcinol...... 3716 xinafoate ...... 3767 Respiratory syncytial virus vaccine (live), bovine ...... 1074 Salmon oil, farmed ...... 3769 Restharrow root ...... 1596 Salmonella Enteritidis vaccine (inactivated) for chickens.. 1151 Rhatany root...... 1597 Salmonella Enteritidis vaccine (live, oral) for chickens..... 1152 Rhatany tincture ...... 1598 Salmonella Typhimurium vaccine (inactivated) for Rhinotracheitis vaccine (inactivated), bovine, infectious.. 1120 chickens ...... 1155 Rhinotracheitis vaccine (inactivated), viral, feline ...... 1113 Salmonella Typhimurium vaccine (live, oral) for Rhinotracheitis vaccine (live), bovine, infectious...... 1121 chickens ...... 1156 Rhinotracheitis vaccine (live), infectious, turkey ...... 1162 Salmonids, infectious pancreatic necrosis vaccine (inactivated Rhinotracheitis vaccine (live), viral, feline ...... 1114 oil-adjuvanted, injectable) for...... 1124 ...... 1598 Salvia miltiorrhiza root and rhizome...... 1610 ...... 3717 Sanguisorba root...... 1611 Riboflavin...... 3718 Saponification value (2.5.6.) ...... 169 Riboflavin sodium phosphate ...... 3720 mesilate...... 3771 Ribose in polysaccharide vaccines (2.5.31.) ...... 177 ...... 1612 Ribwort plantain...... 1599 Saw palmetto fruit ...... 1615 Rice starch ...... 3721 Scanning electron microscopy (2.9.52.)...... 414 Rifabutin ...... 3722 Schisandra fruit...... 1617 ...... 3724 ...... 2909 sodium...... 3725 Scopolamine butylbromide ...... 2910 ...... 3726 Scopolamine hydrobromide...... 2911 dihydrogen phosphate ...... 3728 for veterinary use...... 3773 Risedronate sodium 2.5-hydrate...... 3729 hydrochloride ...... 3775 ...... 3730 Selenium disulfide ...... 3776 ...... 3732 Selenium for homoeopathic preparations ...... 1725 ...... 3736 Selfheal fruit-spike, common...... 1401 Rivastigmine hydrogen tartrate ...... 3737 Semi-micro determination of water (2.5.12.)...... 171 benzoate ...... 3739 Semi-solid ear preparations...... 908 ...... 3740 Semi-solid eye preparations ...... 910 Rolling ball (automatic) and falling ball viscometer methods Semi-solid intrauterine preparations ...... 914 (2.2.49.) ...... 94 Semi-solid nasal preparations...... 920 Roman chamomile flower...... 1384 Semi-solid oromucosal preparations...... 921 hydrochloride ...... 3742 Semi-solid preparations for cutaneous application...... 935 hydrochloride monohydrate ...... 3744

General Notices (1) apply to all monographs and other texts 4287 Index EUROPEAN PHARMACOPOEIA 10.0

Semi-solid preparations for oral use, veterinary ...... 942 Sodium cetostearyl sulfate...... 3810 Semi-solid rectal preparations ...... 935 Sodium chloride...... 3812 Semi-solid vaginal preparations ...... 941 Sodium chromate (51Cr) sterile solution...... 1226 Senega root...... 1618 Sodium citrate...... 3813 Senna leaf...... 1620 Sodium cromoglicate ...... 3813 Senna leaf dry extract, standardised ...... 1621 ...... 3814 Senna pods, Alexandrian...... 1622 Sodium dihydrogen phosphate dihydrate ...... 3816 Senna pods, Tinnevelly...... 1623 Sodium disulfite...... 3829 Separation techniques, chromatographic (2.2.46.)...... 80 Sodium ethyl parahydroxybenzoate...... 3816 ...... 3777 Sodium fluoride ...... 3818 Serratula coronata herb...... 1624 Sodium fluoride (18F) injection...... 1227 nitrate...... 3778 Sodium fusidate ...... 3818 hydrochloride...... 3779 , hydrated ...... 3821 Sesame oil, refined...... 3781 Sodium hyaluronate ...... 3821 Sets for the transfusion of blood and blood components Sodium hydrogen carbonate ...... 3824 (3.3.7.) ...... 475 ...... 3824 Sevoflurane ...... 3783 Sodium iodide...... 3825 Shampoos ...... 916 Sodium iodide (123I) injection ...... 1228 Shear cell methods, powder flow properties by (2.9.49.)..... 411 Sodium iodide (123I) solution for radiolabelling ...... 1228 Shellac ...... 3785 Sodium iodide (131I) capsules for diagnostic use ...... 1229 Shingles (herpes zoster) vaccine (live)...... 1036 Sodium iodide (131I) capsules for therapeutic use ...... 1230 SI (International System) units (1.)...... 3 Sodium iodide (131I) solution ...... 1231 Sialic acid in polysaccharide vaccines (2.5.23.)...... 174 Sodium iodide (131I) solution for radiolabelling ...... 1232 Siam benzoin...... 1341 Sodium iodohippurate (123I) injection ...... 1233 Siam benzoin tincture...... 1342 Sodium iodohippurate (131I) injection ...... 1234 Sieve test (2.9.12.) ...... 343 Sodium iodohippurate dihydrate for radiopharmaceutical Sieves (2.1.4.)...... 16 preparations ...... 1234 Sieving, analytical, particle-size distribution estimation by Sodium lactate solution ...... 3825 (2.9.38.) ...... 392 Sodium laurilsulfate ...... 3827 Sildenafil citrate ...... 3786 Sodium lauroylsarcosinate for external use...... 3828 Silica, colloidal anhydrous...... 3787 Sodium metabisulfite ...... 3829 Silica, colloidal hydrated...... 3788 Sodium methyl parahydroxybenzoate ...... 3830 Silica, dental type...... 3788 Sodium molybdate (99Mo) solution (fission) ...... 1235 Silica, hydrophobic colloidal ...... 3789 Sodium molybdate dihydrate...... 3831 Silicate, aluminium magnesium...... 1799 Sodium ...... 3832 Silicate, aluminium sodium...... 1803 ...... 3832 Silicone elastomer for closures and tubing (3.1.9.)...... 436 , hydrated...... 3833 Silicone oil used as a lubricant (3.1.8.)...... 436 Sodium (99mTc) injection (accelerator- suture, sterile, braided, in distributor for veterinary produced) ...... 1237 use...... 1283 (99mTc) injection (fission) ...... 1238 Silver, colloidal, for external use...... 3790 Sodium pertechnetate (99mTc) injection (non-fission)...... 1240 ...... 3790 Sodium phenylbutyrate...... 3833 ...... 3791 Sodium phosphate (32P) injection...... 1240 ...... 3792 ...... 3835 Single-dose preparations, uniformity of content (2.9.6.)..... 336 Sodium polystyrene sulfonate...... 3836 Single-dose preparations, uniformity of mass (2.9.5.) ...... 335 ...... 3837 Sintered-glass filters (2.1.2.) ...... 15 Sodium propyl parahydroxybenzoate ...... 3838 Sitagliptin phosphate monohydrate ...... 3795 Sodium pyrophosphate decahydrate for radiopharmaceutical Sitagliptin tablets ...... 3796 preparations ...... 1241 Size-exclusion chromatography (2.2.30.)...... 51 Sodium risedronate 2.5-hydrate ...... 3729 (S)-Lactic acid ...... 3051 ...... 3839 Smallpox vaccine (live) ...... 1037 ...... 3840 ([1-11C]) injection...... 1225 Sodium selenite pentahydrate...... 3840 Sodium acetate trihydrate...... 3797 Sodium (S)-lactate solution...... 3826 Sodium alendronate trihydrate...... 3798 Sodium starch glycolate (type A)...... 3841 Sodium alginate ...... 3799 Sodium starch glycolate (type B)...... 3842 Sodium aluminium silicate...... 1803 Sodium starch glycolate (type C)...... 3843 Sodium amidotrizoate...... 3800 Sodium stearate...... 3844 Sodium aminosalicylate dihydrate ...... 3801 Sodium stearyl fumarate...... 3845 Sodium ascorbate ...... 3802 , anhydrous ...... 3846 Sodium aurothiomalate ...... 3804 Sodium sulfate decahydrate...... 3847 ...... 3805 Sodium sulfite ...... 3847 ...... 3806 Sodium sulfite heptahydrate...... 3848 ...... 3807 Sodium tetrachloroaurate dihydrate for homoeopathic Sodium calcium pentetate for radiopharmaceutical preparations ...... 1704 preparations ...... 1223 Sodium ...... 3848 Sodium caprylate ...... 3808 Sodium ...... 3849 Sodium carbonate...... 3809 Soft capsules ...... 906 Sodium carbonate decahydrate...... 3809 Soft extracts...... 867 Sodium carbonate monohydrate ...... 3810 Softening time determination of lipophilic suppositories Sodium carboxymethylcellulose ...... 2093 (2.9.22.) ...... 363 Sodium carboxymethylcellulose, cross-linked...... 2318 Solid dosage forms, dissolution test for (2.9.3.)...... 326 Sodium carboxymethylcellulose, low-substituted ...... 2094

4288 See the information section on general monographs (cover pages) EUROPEAN PHARMACOPOEIA 10.0 Index

Solid dosage forms, recommendations on dissolution testing St. John’s wort...... 1631 of (5.17.1.)...... 801 St. John’s wort dry extract, quantified...... 1633 Solids by mercury porosimetry, porosity and pore-size Standard solutions for limit tests (4.1.2.)...... 598 distribution of (2.9.32.)...... 377 Standards, reference (5.12.)...... 773 Solids, density of (2.2.42.)...... 76 Stannous chloride dihydrate...... 3886 Solids, gas pycnometric density of (2.9.23.) ...... 364 ...... 3887 Solids (porous) including powders, wettability of (2.9.45.).. 406 Staphysagria for homoeopathic preparations ...... 1726 Solifenacin succinate ...... 3850 Star anise...... 1635 Solubility in alcohol of essential oils (2.8.10.)...... 306 Star anise oil ...... 1636 Soluble tablets ...... 939 Starch glycolate (type A), sodium...... 3841 Solution calorimetry and microcalorimetry, characterisation Starch glycolate (type B), sodium...... 3842 of crystalline solids by (2.2.61.) ...... 115 Starch glycolate (type C), sodium...... 3843 Solutions, emulsions and suspensions, oral ...... 917 Starch, hydroxypropyl...... 3888 Solutions for haemodialysis...... 2798 Starch, hydroxypropyl, pregelatinised...... 3890 Solutions for haemodialysis, concentrated, water for Starch, maize ...... 3167 diluting...... 2797 Starch, pea ...... 3492 Solutions for haemofiltration and haemodiafiltration...... 2803 Starch, potato ...... 3611 Solutions for organ preservation ...... 3852 Starch, pregelatinised ...... 3891 Solutions for peritoneal dialysis...... 3515 Starch, rice...... 3721 Solutions, suspensions, intrauterine...... 914 Starch, ...... 4209 Solvents, residual (5.4.) ...... 717 Starches, hydroxyethyl ...... 3892 Solvents, residual, identification and control (2.4.24.)...... 152 Starflower (borage) oil, refined ...... 1992 Somatostatin...... 3853 Statistical analysis of results of biological assays and tests Somatropin...... 3854 (5.3.) ...... 685 Somatropin concentrated solution ...... 3856 ...... 3896 Somatropin for injection ...... 3858 Steam sterilisation of aqueous preparations, application of the Somatropin solution for injection ...... 3860 F0 concept (5.1.5.)...... 628 Sophora flower ...... 1626 ...... 3898 Sophora flower-bud...... 1628 Stearoyl macrogolglycerides...... 3899 Sorbic acid ...... 3861 ...... 3900 Sorbitan laurate...... 3862 Stem cells, human haematopoietic ...... 2857 Sorbitan oleate...... 3862 Stephania root, fourstamen ...... 1438 Sorbitan palmitate ...... 3863 Sterile braided silk suture in distributor for veterinary Sorbitan sesquioleate...... 3863 use...... 1283 Sorbitan stearate ...... 3864 Sterile catgut...... 1269 Sorbitan trioleate ...... 3865 Sterile catgut in distributor for veterinary use...... 1281 Sorbitol...... 3865 Sterile containers of plasticised poly(vinyl chloride) for human Sorbitol, liquid (crystallising) ...... 3867 blood containing anticoagulant solution (3.3.6.) ...... 474 Sorbitol, liquid (non-crystallising) ...... 3867 Sterile linen thread in distributor for veterinary use ...... 1282 Sorbitol, liquid, partially dehydrated ...... 3868 Sterile non-absorbable strands in distributor for veterinary Sorption-desorption isotherms and water activity, use...... 1283 determination of (water-solid interactions) (2.9.39.)...... 394 Sterile non-absorbable sutures...... 1270 hydrochloride...... 3869 Sterile plastic containers for human blood and blood Soya phospholipids for injection ...... 3870 components (3.3.4.)...... 471 Soya-bean oil, hydrogenated ...... 3872 Sterile polyamide suture in distributor for veterinary use.. 1282 Soya-bean oil, refined...... 3873 Sterile poly(ethylene terephthalate) suture in distributor for Spanish sage oil...... 1629 veterinary use...... 1283 Specific surface area by air permeability (2.9.14.) ...... 343 Sterile products, biological indicators and related microbial Specific surface area by gas adsorption (2.9.26.) ...... 369 preparations used in the manufacture of (5.1.2.) ...... 622 dihydrochloride pentahydrate...... 3873 Sterile products, methods of preparation of (5.1.1.) ...... 619 Spectinomycin sulfate tetrahydrate for veterinary use ...... 3875 Sterile single-use plastic syringes (3.3.8.) ...... 477 Spectrometry, atomic absorption (2.2.23.)...... 37 Sterile synthetic absorbable braided sutures ...... 1274 Spectrometry, atomic emission (2.2.22.) ...... 36 Sterile synthetic absorbable monofilament sutures...... 1275 Spectrometry, mass (2.2.43.)...... 77 Sterility (2.6.1.)...... 191 Spectrometry, nuclear magnetic resonance (2.2.33.) ...... 58 Sterility, guidelines for using the test for (5.1.9.)...... 639 Spectrometry, X-ray fluorescence (2.2.37.) ...... 65 Sterols in fatty oils (2.4.23.)...... 150 Spectrophotometry, infrared absorption (2.2.24.) ...... 39 Sticks ...... 937 Spectrophotometry, ultraviolet and visible absorption Sticks, intrauterine...... 914 (2.2.25.) ...... 42 Sticks, nasal ...... 920 Spectroscopy, near-infrared (2.2.40.)...... 70 Stomata and stomatal index (2.8.3.)...... 305 Spectroscopy, Raman (2.2.48.)...... 92 Stramonium leaf ...... 1638 SPF chicken flocks for the production and quality control of Stramonium, prepared ...... 1640 vaccines (5.2.2.)...... 647 Strands, sterile non-absorbable, in distributor for veterinary Spheroids and granules, friability of (2.9.41.) ...... 400 use ...... 1283 Spike lavender oil...... 1630 concentrated solution ...... 3901 ...... 3877 sulfate...... 3902 Spirapril hydrochloride monohydrate ...... 3880 (89Sr) chloride injection...... 1242 ...... 3881 Strychnos ignatii for homoeopathic preparations...... 1719 Spot-on preparations...... 942 Subdivision of tablets ...... 937 Sprays (liquid nasal) and drops (nasal)...... 919 Sublingual sprays, oromucosal drops and oromucosal Sprays, veterinary ...... 942 sprays...... 920 Squalane...... 3883 Sublingual tablets and buccal tablets...... 922 Squalene...... 3886 Substances for pharmaceutical use...... 890

General Notices (1) apply to all monographs and other texts 4289 Index EUROPEAN PHARMACOPOEIA 10.0

Substances for pharmaceutical use, control of impurities in Szechwan lovage rhizome...... 1642 (5.10.) ...... 763 Substances of animal origin for the production of T immunological veterinary medicinal products (5.2.5.) ..... 656 Table of physical characteristics of radionuclides mentioned in Substitution of in vivo method(s) by in vitro method(s) for the the European Pharmacopoeia (5.7.)...... 745 quality control of vaccines (5.2.14.) ...... 679 Tablets ...... 937 Sub-visible particles, particulate contamination (2.9.19.) ... 360 Tablets and capsules, disintegration of (2.9.1.) ...... 323 Sucralfate ...... 3904 Tablets and powders for rectal solutions and suspensions.. 934 ...... 3905 Tablets, buccal ...... 922 Sucrose ...... 3906 Tablets, chewable ...... 939 Sucrose, liquid...... 3908 Tablets, coated...... 938 Sucrose monopalmitate...... 3909 Tablets, dispersible...... 939 Sucrose stearate...... 3911 Tablets, effervescent...... 939 ...... 3912 Tablets for intrauterine solutions and suspensions ...... 914 Sufentanil citrate...... 3913 Tablets for vaginal solutions and suspensions ...... 941 spheres...... 3915 Tablets, gastro-resistant...... 938 Sugars, lead in (2.4.10.)...... 142 Tablets, intrauterine...... 914 Sulbactam sodium ...... 3915 Tablets, modified-release ...... 939 sodium...... 3917 Tablets, orodispersible...... 939 Sulfadiazine ...... 3918 Tablets, resistance to crushing (2.9.8.) ...... 337 Sulfadimethoxine...... 3920 Tablets, soluble...... 939 Sulfadimethoxine sodium for veterinary use...... 3921 Tablets, subdivision of...... 937 Sulfadimidine ...... 3922 Tablets, sublingual ...... 922 Sulfadoxine...... 3924 Tablets, uncoated ...... 938 ...... 3925 Tablets, uncoated, friability of (2.9.7.) ...... 336 Sulfaguanidine ...... 3926 Tablets, vaginal...... 941 Sulfamerazine...... 3926 monohydrate...... 3953 ...... 3927 monohydrate...... 3954 Sulfamethoxazole...... 3928 Tadalafil...... 3957 Sulfamethoxypyridazine for veterinary use...... 3929 ...... 3959 Sulfanilamide...... 3930 citrate...... 3961 Sulfasalazine ...... 3931 Tampons, ear ...... 909 Sulfated ash (2.4.14.) ...... 142 Tampons, medicated ...... 940 Sulfates (2.4.13.)...... 142 Tampons, rectal...... 935 Sulfathiazole ...... 3933 Tampons, vaginal, medicated...... 941 Sulfinpyrazone...... 3934 hydrochloride...... 3963 Sulfobutylbetadex sodium ...... 3935 Tannic acid ...... 3964 Sulfur dioxide (2.5.29.)...... 177 Tannins in herbal drugs (2.8.14.)...... 310 Sulfur for external use...... 3938 hydrochloride ...... 3965 Sulfur for homoeopathic preparations...... 1727 Tapped density and bulk density of powders (2.9.34.)...... 384 Sulfuric acid...... 3938 Tartaric acid...... 3966 ...... 3939 ...... 1643 ...... 3940 Teat dips...... 942 Sultamicillin ...... 3941 Teat sprays ...... 942 Sultamicillin tosilate dihydrate ...... 3944 Technetium (99mTc) bicisate injection ...... 1243 Sumatra benzoin...... 1341 Technetium (99mTc) colloidal rhenium sulfide injection ... 1244 Sumatra benzoin tincture ...... 1343 Technetium (99mTc) colloidal sulfur injection...... 1244 succinate...... 3946 Technetium (99mTc) colloidal tin injection ...... 1245 Sunflower oil, refined ...... 3948 Technetium (99mTc) etifenin injection...... 1246 Supercritical fluid chromatography (2.2.45.) ...... 80 Technetium (99mTc) exametazime injection ...... 1247 Suppositories ...... 934 Technetium (99mTc) gluconate injection ...... 1248 Suppositories and pessaries, disintegration of (2.9.2.)...... 325 Technetium (99mTc) human albumin injection ...... 1249 Suppositories, lipophilic, softening time determination Technetium (99mTc) macrosalb injection ...... 1251 (2.9.22.) ...... 363 Technetium (99mTc) mebrofenin injection...... 1252 Suspensions, solutions and emulsions, oral ...... 917 Technetium (99mTc) medronate injection ...... 1253 Suspensions, solutions, intrauterine...... 914 Technetium (99mTc) mertiatide injection ...... 1254 Sutures for human use: introduction...... 1269 Technetium (99mTc) microspheres injection...... 1255 Sutures, sterile non-absorbable...... 1270 Technetium (99mTc) oxidronate injection ...... 1256 Sutures, sterile synthetic absorbable braided ...... 1274 Technetium (99mTc) pentetate injection ...... 1257 Sutures, sterile synthetic absorbable monofilament ...... 1275 Technetium (99mTc) sestamibi injection...... 1258 ...... 3948 Technetium (99mTc) succimer injection...... 1259 ...... 3949 Technetium (99mTc) tin pyrophosphate injection ...... 1260 Sweet fennel...... 1434 Teicoplanin ...... 3967 Sweet orange oil ...... 1641 ...... 3970 Swelling index (2.8.4.)...... 306 ...... 3972 Swine erysipelas vaccine (inactivated)...... 1158 Temozolomide...... 3973 Swine-fever vaccine (live, prepared in cell cultures), Tenosynovitis vaccine (live), viral, avian ...... 1069 classical ...... 1159 ...... 3974 Symbols and abbreviations (1.)...... 3 hydrochloride dihydrate ...... 3976 Synthetic absorbable braided sutures, sterile ...... 1274 Terbinafine hydrochloride ...... 3978 Synthetic absorbable monofilament sutures, sterile...... 1275 sulfate ...... 3979 Syringes, plastic, sterile single-use (3.3.8.) ...... 477 ...... 3980 Syrups...... 918

4290 See the information section on general monographs (cover pages) EUROPEAN PHARMACOPOEIA 10.0 Index

Terfenadine...... 3982 Tetra-O-acetyl-mannose triflate for radiopharmaceutical Teriparatide ...... 3983 preparations ...... 1261 ...... 3986 ...... 4003 Terminology used in monographs on biological products hydrochloride ...... 4004 (5.2.1.) ...... 647 Thallous (201Tl) chloride injection...... 1262 monohydrate...... 3988 ...... 4005 Test for anticomplementary activity of immunoglobulin ...... 4005 (2.6.17.) ...... 216 Theophylline monohydrate ...... 4007 Test for anti-D antibodies in human immunoglobulin Theophylline-ethylenediamine ...... 4008 (2.6.26.) ...... 230 Theophylline-ethylenediamine hydrate...... 4009 Test for aristolochic acids in herbal drugs (2.8.21) ...... 314 Thermal analysis (2.2.34.)...... 61 Test for extractable volume of parenteral preparations Thermogravimetry (2.2.34.)...... 61 (2.9.17.) ...... 347 ...... 4011 Test for Fc function of immunoglobulin (2.7.9.)...... 279 hydrochloride...... 4012 Test for methanol and 2-propanol (2.9.11.) ...... 342 Thiamine nitrate ...... 4014 Test for neurovirulence of live virus vaccines (2.6.18.)...... 218 ...... 4015 Test for specified micro-organisms (microbiological Thin-layer chromatography (2.2.27.) ...... 47 examination of non-sterile products) (2.6.13.)...... 205 crystallised from ethanol ...... 4016 ...... 3989 Thiocolchicoside hydrate...... 4018 ...... 3991 Thioctic acid...... 4020 Testosterone enantate...... 3992 ...... 4021 ...... 3994 Thiopental sodium and sodium carbonate ...... 4022 ...... 3995 ...... 4024 Tests for extraneous agents in viral vaccines for human use Thioridazine hydrochloride ...... 4025 (2.6.16.) ...... 214 Thomson kudzuvine root ...... 1644 Tests for specified micro-organisms (microbiological Three-lobed sage leaf ...... 1608 examination of live biotherapeutic products) (2.6.38.)...... 255 ...... 4027 Tetanus and diphtheria toxins and toxoids, flocculation value Thyme ...... 1646 (Lf) of, (Ramon assay) (2.7.27.)...... 295 Thyme oil, type...... 1648 Tetanus and diphtheria vaccine (adsorbed) ...... 952 Thyme, wild...... 1669 Tetanus and diphtheria vaccine (adsorbed, reduced antigen(s) Thymol...... 4028 content)...... 953 Thymol type thyme oil...... 1648 Tetanus antitoxin for human use...... 1173 ...... 4029 Tetanus antitoxin for veterinary use...... 1177 for veterinary use...... 4030 Tetanus, diphtheria and hepatitis B (rDNA) vaccine Tiamulin hydrogen fumarate for veterinary use...... 4032 (adsorbed) ...... 954 sodium...... 4035 Tetanus, diphtheria and pertussis (acellular, component) hydrochloride ...... 4036 vaccine (adsorbed) ...... 955 ...... 4037 Tetanus, diphtheria and pertussis (acellular, component) ...... 4039 vaccine (adsorbed, reduced antigen(s) content)...... 956 Ticarcillin sodium ...... 4040 Tetanus, diphtheria and pertussis (whole cell) vaccine Tick-borne encephalitis vaccine (inactivated) ...... 1043 (adsorbed) ...... 958 hydrochloride...... 4041 Tetanus, diphtheria and poliomyelitis (inactivated) vaccine ...... 4043 (adsorbed, reduced antigen(s) content)...... 959 hydrochloride hemihydrate ...... 4045 Tetanus, diphtheria, pertussis (acellular, component) and maleate ...... 4046 haemophilus type b conjugate vaccine (adsorbed) ...... 961 Tinctures...... 867 Tetanus, diphtheria, pertussis (acellular, component) and Tinidazole...... 4048 hepatitis B (rDNA) vaccine (adsorbed) ...... 963 Tinnevelly senna pods...... 1623 Tetanus, diphtheria, pertussis (acellular, component) and ...... 4049 poliomyelitis (inactivated) vaccine (adsorbed)...... 964 ...... 4050 Tetanus, diphtheria, pertussis (acellular, component) and Tiotropium bromide monohydrate ...... 4051 poliomyelitis (inactivated) vaccine (adsorbed, reduced Titanium dioxide ...... 4052 antigen(s) content) ...... 966 Titration, amperometric (2.2.19.)...... 35 Tetanus, diphtheria, pertussis (acellular, component), Titration, potentiometric (2.2.20.)...... 35 hepatitis B (rDNA), poliomyelitis (inactivated) and Titration, voltametric (2.2.65.)...... 119 haemophilus type b conjugate vaccine (adsorbed) ...... 968 Titrations, complexometric (2.5.11.)...... 170 Tetanus, diphtheria, pertussis (acellular, component), hydrochloride ...... 4053 poliomyelitis (inactivated) and haemophilus type b conjugate ...... 4055 vaccine (adsorbed) ...... 970 Tocopherol, all-rac-α-...... 4057 Tetanus, diphtheria, pertussis (whole cell) and poliomyelitis Tocopherol, RRR-α-...... 4058 (inactivated) vaccine (adsorbed) ...... 973 Tocopheryl acetate, all-rac-α- ...... 4059 Tetanus, diphtheria, pertussis (whole cell), poliomyelitis α-Tocopheryl acetate concentrate (powder form)...... 4062 (inactivated) and haemophilus type b conjugate vaccine Tocopheryl acetate, RRR-α-...... 4060 (adsorbed) ...... 974 Tocopheryl hydrogen succinate, DL-α- ...... 4062 Tetanus immunoglobulin, human ...... 2873 Tocopheryl hydrogen succinate, RRR-α-...... 4064 Tetanus vaccine (adsorbed)...... 1042 ...... 4066 Tetanus vaccine (adsorbed), assay of (2.7.8.) ...... 275 ...... 4067 Tetanus vaccine for veterinary use ...... 1161 ...... 4068 ...... 3997 tartrate...... 4070 Tetracaine hydrochloride...... 3998 Tolu balsam ...... 1649 Tetracosactide...... 3999 Toluenesulfonate (methyl, ethyl and isopropyl) in active ...... 4000 substances (2.5.40.)...... 185 Tetracycline hydrochloride...... 4001 ...... 4071

General Notices (1) apply to all monographs and other texts 4291 Index EUROPEAN PHARMACOPOEIA 10.0

Torasemide ...... 4073 for veterinary use...... 4122 Tormentil ...... 1650 Tylosin phosphate bulk solution for veterinary use...... 4127 Tormentil tincture ...... 1650 Tylosin phosphate for veterinary use ...... 4131 Tosylchloramide sodium ...... 4074 Tylosin tartrate for veterinary use ...... 4136 Total ash (2.4.16.)...... 143 Typhae pollen...... 1656 Total cholesterol in oils rich in omega-3 acids (2.4.32.) ...... 163 Typhoid polysaccharide and hepatitis A (inactivated, Total organic carbon in water for pharmaceutical use adsorbed) vaccine...... 982 (2.2.44.) ...... 79 Typhoid polysaccharide vaccine ...... 1044 Total protein (2.5.33.)...... 178 Typhoid vaccine...... 1046 Traditional Chinese medicine, names of herbal drugs used in Typhoid vaccine (live, oral, strain Ty 21a) ...... 1046 (5.22.) ...... 839 Tyrosine ...... 4140 Tragacanth ...... 1651 Tyrothricin...... 4142 hydrochloride...... 4074 Tramazoline hydrochloride monohydrate...... 4076 U Trandolapril...... 4077 Ubidecarenone...... 4147 ...... 4078 Udder-washes...... 942 Transdermal patches ...... 925 Ultraviolet and visible absorption spectrophotometry Transdermal patches, dissolution test for (2.9.4.)...... 333 (2.2.25.) ...... 42 ...... 4079 Ultraviolet ray lamps for analytical purposes (2.1.3.)...... 15 Trehalose dihydrate ...... 4080 Uncaria stem with hooks...... 1657 ...... 4082 Uncoated tablets ...... 938 Triacetin...... 4083 ...... 4148 ...... 4083 Uniformity of content of single-dose preparations (2.9.6.).. 336 ...... 4085 Uniformity of dosage units (2.9.40.) ...... 398 Triamcinolone hexacetonide ...... 4086 Uniformity of dosage units, demonstration using large sample ...... 4088 sizes (2.9.47.)...... 409 ...... 4089 Uniformity of mass of delivered doses from multidose Tributyl acetylcitrate...... 4090 containers (2.9.27.)...... 372 Trichloroacetic acid...... 4092 Uniformity of mass of single-dose preparations (2.9.5.) ..... 335 for veterinary use ...... 4093 Units of the International System (SI) used in the Triethanolamine...... 4106 Pharmacopoeia and equivalence with other units (1.) ...... 3 Triethyl citrate...... 4094 Unsaponifiable matter (2.5.7.)...... 169 Trifluoperazine hydrochloride ...... 4095 ...... 4149 Triflusal ...... 4095 Urofollitropin ...... 4149 Triglycerides, medium-chain ...... 4096 ...... 4151 Triglycerides, omega-3-acid ...... 3423 Uronic acids in polysaccharide vaccines (2.5.22.) ...... 174 Triglycerol diisostearate...... 4097 ...... 4152 hydrochloride ...... 4098 Urtica dioica for homoeopathic preparations...... 1728 maleate ...... 4099 Trimeprazine hemitartrate ...... 1782 V dihydrochloride...... 4100 ...... 4101 Vaccinecomponentassaybyimmunonephelometry Trimethoprim...... 4102 (2.7.35.) ...... 301 maleate...... 4104 Vaccines, adsorbed, aluminium in (2.5.13.)...... 171 Tri-n-butyl phosphate ...... 4091 Vaccines, adsorbed, calcium in (2.5.14.)...... 172 Tritiated (3H) water injection...... 1263 Vaccines and immunosera, phenol in (2.5.15.)...... 172 Trolamine...... 4106 Vaccines and immunosera, veterinary, evaluation of efficacy Trometamol...... 4107 of (5.2.7.)...... 661 Tropicamide...... 4108 Vaccines and immunosera, veterinary, evaluation of safety hydrochloride...... 4110 (5.2.6.) ...... 658 Trospium chloride ...... 4111 Vaccines for human use ...... 893 ...... 4112 Vaccines for human use, cell substrates for the production of Trypsin ...... 4114 (5.2.3.) ...... 650 ...... 4115 Vaccines for human use, conjugated polysaccharide, carrier TSE, animal, minimising the risk of transmitting via human proteins for the production of (5.2.11.) ...... 674 and veterinary medicinal products (5.2.8.) ...... 661 Vaccines for human use, viral, tests for extraneous agents in TSE, animal, products with risk of transmitting agents of.. 884 (2.6.16.) ...... 214 Tuberculin for human use, old...... 4117 Vaccines for veterinary use...... 896 Tuberculin purified protein derivative, avian ...... 4119 Vaccines for veterinary use, inactivated, healthy chicken flocks Tuberculin purified protein derivative, bovine...... 4120 for the production of (5.2.13.) ...... 679 Tuberculin purified protein derivative for human use...... 4120 Vaccines, polysaccharide, hexosamines in (2.5.20.) ...... 173 (BCG) vaccine, freeze-dried...... 949 Vaccines, polysaccharide, methylpentoses in (2.5.21.)...... 173 Tubes for comparative tests (2.1.5.)...... 17 Vaccines, polysaccharide, nucleic acids in (2.5.17.) ...... 172 Tubing and closures, silicone elastomer for (3.1.9.)...... 436 Vaccines, polysaccharide, O-acetyl in (2.5.19.)...... 173 Tubing and containers for total parenteral nutrition Vaccines, polysaccharide, phosphorus in (2.5.18.)...... 172 preparations, poly(ethylene - vinyl acetate) for (3.1.7.)..... 434 Vaccines, polysaccharide, protein in (2.5.16.)...... 172 Tubing used in sets for the transfusion of blood and blood Vaccines, polysaccharide, ribose in (2.5.31.)...... 177 components, materials based on plasticised poly(vinyl Vaccines, polysaccharide, sialic acid in (2.5.23.) ...... 174 chloride) for (3.3.3.) ...... 468 Vaccines, polysaccharide, uronic acids in (2.5.22.) ...... 174 Turkey infectious rhinotracheitis vaccine (live) ...... 1162 Vaccines, SPF chicken flocks for the production and quality Turmeric, Javanese...... 1652 control of (5.2.2.) ...... 647 Turmeric rhizome...... 1653 Vaccines, substitution of in vivo method(s) by in vitro Turpentine oil...... 1655 method(s) for the quality control of (5.2.14.) ...... 679

4292 See the information section on general monographs (cover pages) EUROPEAN PHARMACOPOEIA 10.0 Index

Vaccines, veterinary, cell cultures for the production of Viral rhinotracheitis vaccine (live), feline ...... 1114 (5.2.4.) ...... 654 Viral safety (5.1.7.)...... 637 Vaccines, viral live, test for neurovirulence (2.6.18.) ...... 218 Viral tenosynovitis vaccine (live), avian ...... 1069 Vaginal capsules...... 941 Viral vaccines for human use, tests for extraneous agents in Vaginal foams...... 941 (2.6.16.) ...... 214 Vaginal preparations ...... 940 Viscometer method, capillary (2.2.9.)...... 27 Vaginal preparations, semi-solid ...... 941 Viscometer methods, falling ball and automatic rolling ball Vaginal solutions and suspensions, tablets for...... 941 (2.2.49.) ...... 94 Vaginal solutions, emulsions and suspensions...... 941 Viscose wadding, absorbent ...... 4189 Vaginal tablets...... 941 Viscosity - rotating viscometer method (2.2.10.) ...... 28 Vaginal tampons, medicated ...... 941 Viscosity (2.2.8.)...... 27 hydrochloride ...... 4157 Visible and ultraviolet absorption spectrophotometry Valaciclovir hydrochloride hydrate ...... 4160 (2.2.25.) ...... 42 dry aqueous extract ...... 1659 Visible particles, particulate contamination (2.9.20.) ...... 362 Valerian dry hydroalcoholic extract...... 1660 A ...... 4191 Valerian root...... 1660 concentrate (oily form), synthetic...... 4192 Valerian root, cut ...... 1662 Vitamin A concentrate (powder form), synthetic ...... 4193 Valerian tincture ...... 1664 Vitamin A concentrate (solubilisate/), synthetic.. 4194 Validation of nucleic acid amplification techniques for the Voltametric titration (2.2.65.) ...... 119 detection of B19 virus (B19V) DNA in plasma pools: Volumetric analysis (4.2.) ...... 609 guidelines...... 219 Volumetric solutions (4.2.2.)...... 609 Validation of nucleic acid amplification techniques for the Volumetric solutions, primary standards for (4.2.1.)...... 609 detection of hepatitis C virus (HCV) RNA in plasma pools: von Willebrand factor, human...... 2875 guidelines...... 219 von Willebrand factor, human, assay of (2.7.21.)...... 290 ...... 4162 ...... 4196 hydrochloride for veterinary use ...... 4164 Valproate, sodium...... 3849 W Valproic acid...... 4165 sodium...... 4201 Valsartan ...... 4167 Warfarin sodium clathrate...... 4202 Vancomycin hydrochloride ...... 4168 Washes, nasal...... 920 Vanillin...... 4172 Water ( 15O) injection...... 1264 Vapour, preparations to be converted into...... 928 Water activity and sorption-desorption isotherms, Vardenafil hydrochloride trihydrate...... 4172 determination of (water-solid interactions) (2.9.39.)...... 394 Varicella immunoglobulin for intravenous administration, Water, determination by distillation (2.2.13.)...... 31 human ...... 2875 Water for diluting concentrated haemodialysis solutions.. 2797 Varicella immunoglobulin, human ...... 2875 Water for injections...... 4203 Varicella, measles, mumps and rubella vaccine (live)...... 1006 Water for pharmaceutical use, total organic carbon in Varicella vaccine (live) ...... 1048 (2.2.44.) ...... 79 Vectors for human use, adeno-associated-virus ...... 788 Water for preparation of extracts...... 4206 Vectors for human use, adenovirus...... 782 Water in essential oils (2.8.5.) ...... 306 Vectors for human use, plasmid ...... 780 Water in gases (2.5.28.) ...... 176 Vectors for human use, plasmid, bacterial cells used for the Water: micro determination (2.5.32.) ...... 178 manufacture of...... 781 Water, purified ...... 4207 Vectors for human use, poxvirus...... 784 Water: semi-micro determination (2.5.12.) ...... 171 Vectors for human use, retroviridae-derived ...... 786 Water-solid interactions: determination of sorption- ...... 4173 desorption isotherms and of water activity (2.9.39.) ...... 394 for veterinary use...... 4175 Wettability of porous solids including powders (2.9.45.) .... 406 Vegetable fatty oils...... 901 Wheat starch...... 4209 hydrochloride ...... 4176 Wheat-germ oil, refined...... 4210 hydrochloride...... 4178 Wheat-germ oil, virgin...... 4210 Verbena herb ...... 1665 White beeswax ...... 1931 Veterinary liquid preparations for cutaneous application... 941 White horehound ...... 1667 Veterinary medicinal products, immunological, substances of White peony root...... 1573 animal origin for the production of (5.2.5.)...... 656 White soft paraffin...... 3485 Veterinary semi-solid preparations for oral use ...... 942 Wild pansy (flowering aerial parts)...... 1668 Veterinary vaccines and immunosera, evaluation of efficacy of Wild thyme...... 1669 (5.2.7.) ...... 661 Willow bark...... 1671 Viability, nucleated cell count and (2.7.29.) ...... 297 Willow bark dry extract...... 1672 Vibriosis (cold-water) vaccine (inactivated) for Wool ...... 4210 salmonids...... 1163 Wool fat...... 4211 Vibriosis vaccine (inactivated) for salmonids...... 1164 Wool fat, hydrogenated...... 4215 VICH (5.8.)...... 755 Wool fat, hydrous...... 4216 ...... 4180 Wormwood...... 1673 Vinblastine sulfate ...... 4181 ...... 4182 X Vincristine sulfate...... 4183 Xanthan gum...... 4221 Vindesine sulfate...... 4185 133 Vinorelbine tartrate ...... 4186 ( Xe) injection ...... 1264 Vinpocetine ...... 4188 X-ray fluorescence spectrometry (2.2.37.)...... 65 Viper venom antiserum, European ...... 1174 X-ray powder diffraction (XRPD), characterisation of Viral diarrhoea vaccine (inactivated), bovine...... 1075 crystalline and partially crystalline solids by (2.9.33.)...... 379 Viral hepatitis type I vaccine (live), duck ...... 1099 hydrochloride for veterinary use ...... 4222 Viral rhinotracheitis vaccine (inactivated), feline ...... 1113 ...... 4223

General Notices (1) apply to all monographs and other texts 4293 Index EUROPEAN PHARMACOPOEIA 10.0

Xylometazoline hydrochloride...... 4225 dihydrate...... 4238 Xylose ...... 4226 Zinc acexamate ...... 4239 ...... 4241 Y ...... 4241 Yarrow ...... 1674 ...... 4242 Yeasticidal, bactericidal or fungicidal activity of antiseptic Zinc stearate ...... 4242 medicinal products, determination of (5.1.11.)...... 643 heptahydrate ...... 4243 Yellow beeswax...... 1932 Zinc sulfate hexahydrate...... 4244 vaccine (live) ...... 1049 Zinc sulfate monohydrate...... 4244 Yellow soft paraffin...... 3486 Zinc undecylenate ...... 4244 Yersiniosis vaccine (inactivated) for salmonids...... 1102 hydrochloride monohydrate...... 4245 hydrochloride...... 4231 Ziprasidone mesilate trihydrate...... 4247 Yttrium (90Y) chloride solution for radiolabelling...... 1265 Zoledronic acid monohydrate...... 4249 ...... 4251 Z tartrate...... 4252 ...... 4254 hydrate ...... 4235 Zoster (shingles) vaccine (live), herpes...... 1036 Zanthoxylum bungeanum pericarp...... 1675 decanoate...... 4255 ...... 4236

4294 See the information section on general monographs (cover pages)