歐洲藥典10 EP10

第十版一目了然

The Pharmacopoeia you need to comply with in order to market your products in 38 European countries and beyond.

With 114 new and 683 revised texts, approximately 30% of the content is new or revised compared to Edition 9.0.

It contains 2 420 monographs, 374 general texts (including general monographs and methods of analysis) and around 2 780 descriptions of reagents.

the 10th Edition consists of 3 initial volumes (10.0) complemented by 8 non-cumulative supplements (10.1 to 10.8). For the convenience of users, direct access to complementary information (Knowledge Database) is included for each monograph and general chapters through a data matrix code. Available in either English or French, the print version contains a subscription key (EPID code) that allows access to online archives.
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歐洲藥典10 EP10相關內(nèi)容

Ph. Eur. Introduction to the 10th Edition（歐洲藥典第十版導論）

Ph. Eur. Contents of the 10th Edition（歐洲藥典第十版目錄）

Ph. Eur. English Index 10th Edition（歐洲藥典英文索引第10版 10.0-10.6）

Ph. Eur. Latin Index 10th Edition（歐洲藥典拉丁語索引第10版）

Comments concerning revised texts published in Edition 10.0（關于10.0版修訂文本的評論）

NEW TEXTS

The following texts appear for the first time in the European Pharmacopoeia. They will be implemented on 1 January 2020at the latest. at the latest.

1. GENERAL CHAPTERS
   
   
   1. 2.6.35. Quantification and characterisation of residual host-cell DNA
   
   
   2. 2.9.49. Powder flow properties by shear cell methods
   
   
   3. 2.9.52. Scanning electron microscopy
   
   
   4. 3.3. Containers for human blood and blood components,and materials used in their manufacture; transfusion sets and materials used in their manufacture; syringes
   
   
   5. 5.25. Process analytical technology
   
   
2. MONOGRAPHS
   1. Vaccines for veterinary use
      
      
      1. Infectious pancreatic necrosis vaccine (inactivated,oil-adjuvanted, injectable) for salmonids (3063)
      
      
   2. Herbal drugs and herbal drug preparations
      
      
      1. Abelmoschi corolla (2827)
      
      
      2. Serratula coronata herb (2754)
      
      
   3. Monographs
      
      
      1. Benzydamine hydrochloride (2759)
      
      
      2. Cocoa butter (2607)
      
      
      3. Octreotide (2414)
      
      
      4. Prasugrel hydrochloride (3040)
      
      
      5. Squalene (2805)
      
      
      6. Tapentadol hydrochloride (3035)
      
      
      7. Tetracaine (2909)
      
      
      8. Topiramate (2616)
      
      
      9. Vincamine (1800)
      
      

REVISED TEXTS

The following texts have been technically revised since their last publication. They will be implemented on 1 January 2020 at the latest.

1. GENERAL CHAPTERS
   
   
   1. 2.2.25. Absorption spectrophotometry, ultraviolet and visible
   
   
   2. 2.6.8. Pyrogens
   
   
   3. 2.6.33. Residual pertussis toxin
   
   
   4. 2.7.2. Microbiological assay of antibiotics
   
   
   5. 2.7.23. Numeration of CD34/CD45+ cells in haematopoietic products
   
   
   6. 5.8. Pharmacopoeial harmonisation
   
   
   7. 2.7.35. Immunonephelometry for vaccine component assay
   
   
   8. 2.8.25. High-performance thin-layer chromatography of herbal drugs and herbal drug preparations
   
   
   9. 2.9.1. Disintegration of tablets and capsules
   
   
   10. 2.9.20. Particulate contamination: visible particles
   
   
   11. 3.1.13. Plastic additives
   
   
   12. 3.3.1. Materials for containers for human blood and blood components
   
   
   13. 3.3.2. Materials based on plasticised poly(vinyl chloride) for containers for human blood and blood components
   
   
   14. 3.3.3. Materials based on plasticised poly(vinyl chloride) for tubing used in sets for the transfusion of blood and blood components
   
   
   15. 3.3.4. Sterile plastic containers for human blood and blood components
   
   
   16. 3.3.5. Empty sterile containers of plasticised poly(vinyl chloride) for human blood and blood components
   
   
   17. 3.3.6. Sterile containers of plasticised poly(vinyl chloride) for human blood containing anticoagulant solution
   
   
   18. 3.3.7. Sets for the transfusion of blood and blood components
   
   
   19. 3.3.8. Sterile single-use plastic syringes
   
   
   20. 4. Reagents
   
   
   21. 5.3. Statistical analysis of results of biological assays and tests
   
   
   22. 5.8. Pharmacopoeial harmonisation
   
   
   23. 5.21. Chemometric methods applied to analytical data
   
   
   24. 5.22. Names of herbal drugs used in traditional Chinese medicine
   
   
   25. 5.24. Chemical imaging
   
   
2. MONOGRAPHS
   1. Dosage forms
      
      
      1. Powders, oral (1165)
      
      
   2. Vaccines for human use
      
      
      1. Diphtheria, tetanus and pertussis (acellular, component) vaccine (adsorbed) (1931)
      
      
      2. Diphtheria, tetanus and pertussis (acellular, component) vaccine (adsorbed, reduced antigen(s) content) (2764)
      
      
      3. Diphtheria, tetanus, pertussis (acellular, component) and haemophilus type b conjugate vaccine (adsorbed) (1932)
      
      
      4. Diphtheria, tetanus, pertussis (acellular, component) and hepatitis B (rDNA) vaccine (adsorbed) (1933)
      
      
      5. Diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine (adsorbed) (1934)
      
      
      6. Diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine (adsorbed, reduced antigen(s) content) (2329)
      
      
      7. Diphtheria, tetanus, pertussis (acellular, component),hepatitis B (rDNA), poliomyelitis (inactivated) and haemophilus type b conjugate vaccine (adsorbed) (2067)
      
      
      8. Diphtheria, tetanus, pertussis (acellular, component),poliomyelitis (inactivated) and haemophilus type b conjugate vaccine (adsorbed) (2065)
      
      
      9. Influenza vaccine (surface antigen, inactivated, prepared in cell cultures) (2149)
      
      
      10. Influenza vaccine (whole virion, inactivated, prepared in cell cultures) (2308)
      
      
      11. Pertussis vaccine (acellular, component, adsorbed) (1356)
      
      
      12. Pertussis vaccine (acellular, co-purified, adsorbed) (1595)
      
      
      13. Poliomyelitis vaccine (oral) (0215)
      
      
      14. Yellow fever vaccine (live) (0537)
      
      
   3. Vaccines for veterinary use
      
      
      1. Enteric redmouth disease vaccine (inactivated) for rainbow trout (1950)
      
      
   4. Immunosera for human use
      
      
      1. Enteric redmouth disease vaccine (inactivated) for rainbow trout (1950)
      
      
   5. Vaccines for veterinary use
      
      
      1. Botulinum antitoxin (0085)
      
      
   6. Herbal drugs and herbal drug preparations
      
      
      1. Indigo plant leaf (2727)
      
      
   7. Monographs
      
      
      1. Alfacalcidol (1286)
      
      
      2. Aluminium magnesium silicate (1388)
      
      
      3. Anticoagulant and preservative solutions for human blood (0209)
      
      
      4. Apomorphine hydrochloride hemihydrate (0136)
      
      
      5. Arachis oil, hydrogenated (1171)
      
      
      6. Benserazide hydrochloride (1173)
      
      
      7. Biotin (1073)
      
      
      8. Boldine (2971)
      
      
      9. Borage (starflower) oil, refined (2105)
      
      
      10. Caffeine (0267)
      
      
      11. Caffeine monohydrate (0268)
      
      
      12. Candesartan cilexetil (2573)
      
      
      13. Carmellose sodium (0472)
      
      
      14. Carmellose sodium, low-substituted (1186)
      
      
      15. Carmustine (1187)
      
      
      16. Castor oil, hydrogenated (1497)
      
      
      17. Castor oil, refined (2367)
      
      
      18. Castor oil, virgin (0051)
      
      
      19. Cellulose, microcrystalline (0316)
      
      
      20. Cetyl palmitate (1906)
      
      
      21. Chlorpromazine hydrochloride (0475)
      
      
      22. Chlortalidone (0546)
      
      
      23. Cholesterol for parenteral use (2397)
      
      
      24. Cod-liver oil (type A) (1192)
      
      
      25. Cod-liver oil (type B) (1193)
      
      
      26. Copovidone (0891)
      
      
      27. Cottonseed oil, hydrogenated (1305)
      
      
      28. Croscarmellose sodium (0985)
      
      
      29. Desipramine hydrochloride (0481)
      
      
      30. Diacerein (2409)
      
      
      31. Diethylene glycol palmitostearate (1415)
      
      
      32. Ethylene glycol monopalmitostearate (1421)
      
      
      33. Evening primrose oil, refined (2104)
      
      
      34. Fenoterol hydrobromide (0901)
      
      
      35. Fish oil, rich in omega-3 acids (1912)
      
      
      36. Follitropin (2285)
      
      
      37. Follitropin concentrated solution (2286)
      
      
      38. Galactose (1215)
      
      
      39. Galantamine hydrobromide (2366)
      
      
      40. Gelatin (0330)
      
      
      41. Glycerol dibehenate (1427)
      
      
      42. Glycerol distearate (1428)
      
      
      43. Glycerol monostearate 40-55 (0495)
      
      
      44. Gonadotrophin, chorionic (0498)
      
      
      45. Hard fat (0462)
      
      
      46. Hard fat with additives (2731)
      
      
      47. Heparin calcium (0332)
      
      
      48. Heparin sodium (0333)
      
      
      49. Human measles immunoglobulin (0397)
      
      
      50. Human plasma for fractionation (0853)
      
      
      51. Human plasma (pooled and treated for virus inactivation) (1646)
      
      
      52. Imidacloprid for veterinary use (2924)
      
      
      53. Infliximab concentrated solution (2928)
      
      
      54. Irbesartan (2465)
      
      
      55. Lauromacrogol 400 (2046)
      
      
      56. Levodropropizine (1535)
      
      
      57. Losartan potassium (2232)
      
      
      58. Macrogol 15 hydroxystearate (2052)
      
      
      59. Macrogol 30 dipolyhydroxystearate (2584)
      
      
      60. Mesterolone (1730)
      
      
      61. Olmesartan medoxomil (2600)
      
      
      62. Oxytetracycline hydrochloride (0198)
      
      
      63. Palmitic acid (1904)
      
      
      64. Penicillamine (0566)
      
      
      65. Phenylpropanolamine hydrochloride (0683)
      
      
      66. Phytomenadione, racemic (3011)
      
      
      67. Propranolol hydrochloride (0568)
      
      
      68. Propyl gallate (1039)
      
      
      69. Propylene glycol monopalmitostearate (1469)
      
      
      70. Protamine sulfate (0569)
      
      
      71. Pyridoxine hydrochloride (0245)
      
      
      72. Safflower oil, refined (2088)
      
      
      73. Sodium starch glycolate (type A) (0983)
      
      
      74. Sodium starch glycolate (type B) (0984)
      
      
      75. Sodium starch glycolate (type C) (1566)
      
      
      76. Solutions for organ preservation (1264)
      
      
      77. Soya-bean oil, hydrogenated (1265)
      
      
      78. Soya-bean oil, refined (1473)
      
      
      79. Squalane (1630)
      
      
      80. Sucralfate (1796)
      
      
      81. Terbutaline sulfate (0690)
      
      
      82. Tilidine hydrochloride hemihydrate (1767)
      
      
      83. Triglycerides, medium-chain (0868)
      
      
      84. Urofollitropin (0958)
      
      
      85. Urokinase (0695)
      
      
      86. Valsartan (2423)
      
      
      87. Vigabatrin (2305)
      
      
      88. Vinorelbine tartrate (2107)
      
      
      89. Wheat starch (0359)
      
      
      90. Wheat-germ oil, refined (1379)
      
      
      91. Wheat-germ oil, virgin (1480)
      
      

CORRECTED TEXTS

The following texts have been corrected for the 10th Edition and specify ‘corrected 10.0’ above the title. These corrections are to be taken into account as soon as possible and not later than 31 August 2019 (the end of the month following the month of publication of the 10th Edition).

1. GENERAL CHAPTERS
   
   
   1. 1. General notices
   
   
   2. 2.2.5. Relative density
   
   
   3. 2.2.29. Liquid chromatography
   
   
   4. 2.2.31. Electrophoresis
   
   
   5. 2.4.23. Sterols in fatty oils
   
   
   6. 2.4.25. Ethylene oxide and dioxan
   
   
   7. 2.4.26. N,N-Dimethylaniline
   
   
   8. 2.4.32. Total cholesterol in oils rich in omega-3 acids
   
   
   9. 2.5.19. O-Acetyl in polysaccharide vaccines
   
   
   10. 2.5.37. Methyl, ethyl and isopropyl methanesulfonate in methanesulfonic acid
   
   
   11. 2.5.38. Methyl, ethyl and isopropyl methanesulfonate in active substances
   
   
   12. 2.5.39. Methanesulfonyl chloride in methanesulfonic acid
   
   
   13. 2.5.40. Methyl, ethyl and isopropyl toluenesulfonate in active substances
   
   
   14. 2.5.41. Methyl, ethyl and isopropyl benzenesulfonate in active substances
   
   
   15. 2.7.8. Assay of tetanus vaccine (adsorbed)
   
   
   16. 2.8.9. Residue on evaporation of essential oils
   
   
   17. 2.9.10. Ethanol content
   
   
   18. 2.9.11. Test for methanol and 2-propanol
   
   
   19. 3.1.14. Materials based on plasticised poly(vinyl chloride) for containers for aqueous solutions for intravenous infusion
   
   
   20. 3.2. Containers
   
   
   21. 5.1.2. Biological indicators and related microbial preparations used in the manufacture of sterile products
   
   
   22. 5.1.6. Alternative methods for control of microbiological quality
   
   
   23. 5.2.12. Raw materials of biological origin for the production of cell-based and gene therapy medicinal products
   
   
   24. 5.9. Polymorphism
   
   
   25. 5.10. Control of impurities in substances for pharmaceutical use
   
   
   26. 5.12. Reference standards
   
   
   27. 5.15. Functionality-related characteristics of excipients
   
   
   28. 5.16. Crystallinity
   
   
2. MONOGRAPHS
   1. General monographs
      
      
      1. Chemical precursors for radiopharmaceutical preparations (2902)
      
      
      2. Immunosera for human use, animal (0084)
      
      
      3. Immunosera for veterinary use (0030)
      
      
      4. Live biotherapeutic products for human use (3053)
      
      
      5. Vaccines for human use (0153)
      
      
      6. Vaccines for veterinary use (0062)
      
      
   2. Dosage forms
      
      
      1. Ear preparations (0652)
      
      
      2. Eye preparations (1163)
      
      
      3. Intramammary preparations for veterinary use (0945)
      
      
      4. Liquid preparations for cutaneous application (0927)
      
      
      5. Nasal preparations (0676)
      
      
      6. Parenteral preparations (0520)
      
      
      7. Rectal preparations (1145)
      
      
      8. Semi-solid preparations for cutaneous application (0132)
      
      
      9. Vaginal preparations (1164)
      
      
   3. Vaccines for human use
      
      
      1. Anthrax vaccine for human use (adsorbed, prepared from culture filtrates) (2188)
      
      
      2. Diphtheria and tetanus vaccine (adsorbed) (0444)
      
      
      3. Diphtheria and tetanus vaccine (adsorbed, reduced antigen(s) content) (0647)
      
      
      4. Diphtheria, tetanus and pertussis (whole cell) vaccine (adsorbed) (0445)
      
      
      5. Diphtheria, tetanus and poliomyelitis (inactivated) vaccine (adsorbed, reduced antigen(s) content) (2328)
      
      
      6. Diphtheria vaccine (adsorbed) (0443)
      
      
      7. Diphtheria vaccine (adsorbed, reduced antigen content) (0646)
      
      
      8. Influenza vaccine (live, nasal) (2772)
      
      
      9. Influenza vaccine (split virion, inactivated) (0158)
      
      
      10. Influenza vaccine (surface antigen, inactivated) (0869)
      
      
      11. Influenza vaccine (surface antigen, inactivated, virosome) (2053)
      
      
      12. Influenza vaccine (whole virion, inactivated) (0159)
      
      
      13. Measles, mumps, rubella and varicella vaccine (live) (2442)
      
      
      14. Pneumococcal polysaccharide vaccine (0966)
      
      
      15. Poliomyelitis vaccine (inactivated) (0214)
      
      
      16. Shingles (herpes zoster) vaccine (live) (2418)
      
      
      17. Tetanus vaccine (adsorbed) (0452)
      
      
      18. Typhoid polysaccharide vaccine (1160)
      
      
      19. Varicella vaccine (live) (0648)
      
      
   4. Immunosera for human use
      
      
      1. Viper venom antiserum, European (0145)
      
      
   5. Radiopharmaceutical preparations and starting materials for radiopharmaceutical preparations
      
      
      1. Choline ([11C]methyl) injection (2462)
      
      
      2. Copper tetramibi tetrafluoroborate for radiopharmaceutical preparations (2547)
      
      
      3. Fluorocholine (18F) injection (2793)
      
      
   6. Sutures for human use
      
      
      1. Sutures for human use: introduction (90004)
      
      
      2. Sutures, sterile non-absorbable (0324)
      
      
   7. Herbal drugs and herbal drug preparations
      
      
      1. Herbal drugs: introduction (90029)
      
      
      2. Achyranthes bidentata root (2999)
      
      
      3. Akebia stem (2472)
      
      
      4. Aloes dry extract, standardised (0259)
      
      
      5. Amomum fruit (2554)
      
      
      6. Artichoke leaf (1866)
      
      
      7. Belladonna, prepared (0222)
      
      
      8. Capsicum soft extract, standardised (2529)
      
      
      9. Cassia oil (1496)
      
      
      10. Cinnamon bark oil, Ceylon (1501)
      
      
      11. Fennel, bitter (0824)
      
      
      12. Fennel, sweet (0825)
      
      
      13. Gentian tincture (1870)
      
      
      14. Ginger (1522)
      
      
      15. Goldenseal rhizome (1831)
      
      
      16. Juniper oil (1832)
      
      
      17. Long pepper (2453)
      
      
      18. Mandarin oil (2355)
      
      
      19. Mastic (1876)
      
      
      20. Myrrh tincture (1877)
      
      
      21. Nutmeg oil (1552)
      
      
      22. Opium tincture, standardised (1841)
      
      
      23. Oregano (1880)
      
      
      24. Pepper (2477)
      
      
      25. Roselle (1623)
      
      
      26. Round amomum fruit (2555)
      
      
      27. Sage tincture (1889)
      
      
      28. Saw palmetto extract (2579)
      
      
      29. Saw palmetto fruit (1848)
      
      
      30. Star anise (1153)
      
      
      31. Stramonium, prepared (0247)
      
      
      32. Sweet orange oil (1811)
      
      
      33. Thyme oil, thymol type (1374)
      
      
      34. Turmeric rhizome (2543)
      
      
   8. Homoeopathic preparations
      
      
      1. Homoeopathic preparations: introduction (90006)
      
      
      2. Agaricus phalloides for homoeopathic preparations (2290)
      
      
      3. Anacardium for homoeopathic preparations (2094)
      
      
      4. Belladonna for homoeopathic preparations (2489)
      
      
      5. Cocculus for homoeopathic preparations (2486)
      
      
      6. Hydrastis canadensis for homoeopathic preparations (2500)
      
      
      7. Ignatia for homoeopathic preparations (2513)
      
      
      8. Magnesium phosphoricum for homoeopathic preparations (2505)
      
      
      9. Nux-vomica for homoeopathic preparations (2514)
      
      
      10. Staphysagria for homoeopathic preparations (2289)
      
      
   9. Monographs
      
      
      1. N-Acetyltyrosine (1384)
      
      
      2. Alimemazine hemitartrate (2650)
      
      
      3. Almagate (2010)
      
      
      4. Alprazolam (1065)
      
      
      5. Alprenolol hydrochloride (0876)
      
      
      6. Aluminium hydroxide, hydrated, for adsorption (1664)
      
      
      7. Aluminium stearate (1663)
      
      
      8. Alverine citrate (2156)
      
      
      9. Amantadine hydrochloride (0463)
      
      
      10. Amikacin sulfate (1290)
      
      
      11. 4-Aminobenzoic acid (1687)
      
      
      12. Amoxicillin sodium (0577)
      
      
      13. Amphotericin B (1292)
      
      
      14. Ampicillin sodium (0578)
      
      
      15. Anti-T lymphocyte immunoglobulin for human use, animal (1928)
      
      
      16. Aprotinin (0580)
      
      
      17. Aprotinin concentrated solution (0579)
      
      
      18. Arginine hydrochloride (0805)
      
      
      19. Aripiprazole (2617)
      
      
      20. Articaine hydrochloride (1688)
      
      
      21. Atazanavir sulfate (2898)
      
      
      22. Atropine (2056)
      
      
      23. Atropine sulfate (0068)
      
      
      24. Azelastine hydrochloride (1633)
      
      
      25. Bacitracin (0465)
      
      
      26. Bacitracin zinc (0466)
      
      
      27. Benzalkonium chloride (0372)
      
      
      28. Benzalkonium chloride solution (0371)
      
      
      29. Benzyl alcohol (0256)
      
      
      30. Benzyl benzoate (0705)
      
      
      31. Benzylpenicillin (benzathine) tetrahydrate (0373)
      
      
      32. Benzylpenicillin potassium (0113)
      
      
      33. Benzylpenicillin (procaine) monohydrate (0115)
      
      
      34. Benzylpenicillin sodium (0114)
      
      
      35. Biperiden hydrochloride (1074)
      
      
      36. Bismuth subsalicylate (1495)
      
      
      37. Bleomycin sulfate (0976)
      
      
      38. Botulinum toxin type A for injection (2113)
      
      
      39. Botulinum toxin type B for injection (2581)
      
      
      40. Brimonidine tartrate (2760)
      
      
      41. Bromhexine hydrochloride (0706)
      
      
      42. Brompheniramine maleate (0977)
      
      
      43. Bupivacaine hydrochloride (0541)
      
      
      44. Buserelin (1077)
      
      
      45. Calcitonin (salmon) (0471)
      
      
      46. Calcium folinate hydrate (0978)
      
      
      47. Calcium glucoheptonate (1399)
      
      
      48. Calcium levofolinate hydrate (1606)
      
      
      49. Captopril (1079)
      
      
      50. Carbimazole (0884)
      
      
      51. Cefalotin sodium (0987)
      
      
      52. Cefamandole nafate (1402)
      
      
      53. Cefapirin sodium (1650)
      
      
      54. Cefazolin sodium (0988)
      
      
      55. Cefepime dihydrochloride monohydrate (2126)
      
      
      56. Cefoperazone sodium (1404)
      
      
      57. Cefotaxime sodium (0989)
      
      
      58. Cefoxitin sodium (0990)
      
      
      59. Ceftazidime pentahydrate (1405)
      
      
      60. Ceftazidime pentahydrate with sodium carbonate for injection(2344)
      
      
      61. Ceftriaxone sodium (0991)
      
      
      62. Cefuroxime axetil (1300)
      
      
      63. Cefuroxime sodium (0992)
      
      
      64. Cetostearyl alcohol (0702)
      
      
      65. Cetostearyl alcohol (type A), emulsifying (0801)
      
      
      66. Cetostearyl alcohol (type B), emulsifying (0802)
      
      
      67. Cetyl alcohol (0540)
      
      
      68. Chloramphenicol (0071)
      
      
      69. Chloramphenicol palmitate (0473)
      
      
      70. Chloramphenicol sodium succinate (0709)
      
      
      71. Chlorobutanol (0382)
      
      
      72. Chlorobutanol hemihydrate (0383)
      
      
      73. Chlorocresol (0384)
      
      
      74. Chlortetracycline hydrochloride (0173)
      
      
      75. Cholesterol (0993)
      
      
      76. Ciclopirox (1407)
      
      
      77. Ciclosporin (0994)
      
      
      78. Cilastatin sodium (1408)
      
      
      79. Cladribine (2174)
      
      
      80. Clemastine fumarate (1190)
      
      
      81. Clindamycin phosphate (0996)
      
      
      82. Clioquinol (2111)
      
      
      83. Clodronate disodium tetrahydrate (1777)
      
      
      84. Clofibrate (0318)
      
      
      85. Clonidine hydrochloride (0477)
      
      
      86. Clopidogrel besilate (2790)
      
      
      87. Clopidogrel hydrochloride (2791)
      
      
      88. Clopidogrel hydrogen sulfate (2531)
      
      
      89. Cloxacillin sodium (0661)
      
      
      90. Codeine hydrochloride dihydrate (1412)
      
      
      91. Codeine monohydrate (0076)
      
      
      92. Codeine phosphate hemihydrate (0074)
      
      
      93. Colestyramine (1775)
      
      
      94. Colistimethate sodium (0319)
      
      
      95. Colistin sulfate (0320)
      
      
      96. Crospovidone (0892)
      
      
      97. Cyclizine hydrochloride (1092)
      
      
      98. Cysteine hydrochloride monohydrate (0895)
      
      
      99. Cytarabine (0760)
      
      
      100. Dacarbazine (1691)
      
      
      101. Danaparoid sodium (2090)
      
      
      102. Daunorubicin hydrochloride (0662)
      
      
      103. Deferiprone oral solution (2987)
      
      
      104. Deferoxamine mesilate (0896)
      
      
      105. Demeclocycline hydrochloride (0176)
      
      
      106. Desflurane (1666)
      
      
      107. Desloratadine (2570)
      
      
      108. Desmopressin (0712)
      
      
      109. Detomidine hydrochloride for veterinary use (1414)
      
      
      110. Dexchlorpheniramine maleate (1196)
      
      
      111. Dibutyl phthalate (0762)
      
      
      112. Diclofenac potassium (1508)
      
      
      113. Diclofenac sodium (1002)
      
      
      114. Dicloxacillin sodium (0663)
      
      
      115. Dicycloverine hydrochloride (1197)
      
      
      116. Diethyl phthalate (0897)
      
      
      117. Diethylene glycol monoethyl ether (1198)
      
      
      118. Dihydrostreptomycin sulfate for veterinary use (0485)
      
      
      119. Dimetindene maleate (1417)
      
      
      120. Docusate sodium (1418)
      
      
      121. Doxorubicin hydrochloride (0714)
      
      
      122. Doxycycline hyclate (0272)
      
      
      123. Doxycycline monohydrate (0820)
      
      
      124. Doxylamine hydrogen succinate (1589)
      
      
      125. Duloxetine hydrochloride (2594)
      
      
      126. Edrophonium chloride (2106)
      
      
      127. Enalapril maleate (1420)
      
      
      128. Enilconazole for veterinary use (1720)
      
      
      129. Enrofloxacin for veterinary use (2229)
      
      
      130. Epirubicin hydrochloride (1590)
      
      
      131. Erythromycin lactobionate (1098)
      
      
      132. Erythropoietin concentrated solution (1316)
      
      
      133. Estrogens, conjugated (1512)
      
      
      134. Ethacridine lactate monohydrate (1591)
      
      
      135. Ethanol (96 per cent) (1317)
      
      
      136. Ethanol, anhydrous (1318)
      
      
      137. Ethylcellulose (0822)
      
      
      138. Etofenamate (1513)
      
      
      139. Eugenol (1100)
      
      
      140. Everolimus (2918)
      
      
      141. Felypressin (1634)
      
      
      142. Fentanyl citrate (1103)
      
      
      143. Fenticonazole nitrate (1211)
      
      
      144. Filgrastim concentrated solution (2206)
      
      
      145. Filgrastim injection (2848)
      
      
      146. Flucloxacillin sodium (0668)
      
      
      147. Folic acid hydrate (0067)
      
      
      148. Foscarnet sodium hexahydrate (1520)
      
      
      149. Fosfomycin sodium (1329)
      
      
      150. Framycetin sulfate (0180)
      
      
      151. Fulvestrant (2443)
      
      
      152. Gadobutrol monohydrate (2735)
      
      
      153. Gadodiamide hydrate (2225)
      
      
      154. Gemcitabine hydrochloride (2306)
      
      
      155. Gentamicin sulfate (0331)
      
      
      156. Glipizide (0906)
      
      
      157. Glucagon, human (1635)
      
      
      158. Glycerol (0496)
      
      
      159. Glycerol (85 per cent) (0497)
      
      
      160. Glycerol monocaprylate (2213)
      
      
      161. Glycerol monocaprylocaprate (2392)
      
      
      162. Gonadorelin acetate (0827)
      
      
      163. Gonadotrophin, equine serum, for veterinary use (0719)
      
      
      164. Gramicidin (0907)
      
      
      165. Guaiacol (1978)
      
      
      166. Halothane (0393)
      
      
      167. Heparins, low-molecular-mass (0828)
      
      
      168. Heptaminol hydrochloride (1980)
      
      
      169. Histidine hydrochloride monohydrate (0910)
      
      
      170. Human coagulation factor VIIa (rDNA) concentrated solution(2534)
      
      
      171. Human coagulation factor IX (rDNA) concentrated solution(2522)
      
      
      172. Hyaluronidase (0912)
      
      
      173. Hydroxychloroquine sulfate (2849)
      
      
      174. Hydroxyethylcellulose (0336)
      
      
      175. Hydroxypropylcellulose (0337)
      
      
      176. Hydroxypropylcellulose, low-substituted (2083)
      
      
      177. Hyoscyamine sulfate (0501)
      
      
      178. Hypromellose (0348)
      
      
      179. Imipenem monohydrate (1226)
      
      
      180. Insulin aspart (2084)
      
      
      181. Insulin, bovine (1637)
      
      
      182. Insulin glargine (2571)
      
      
      183. Insulin, human (0838)
      
      
      184. Insulin lispro (2085)
      
      
      185. Insulin, porcine (1638)
      
      
      186. Insulin preparations, injectable (0854)
      
      
      187. Interferon alfa-2 concentrated solution (1110)
      
      
      188. Interferon beta-1a concentrated solution (1639)
      
      
      189. Interferon gamma-1b concentrated solution (1440)
      
      
      190. Iohexol (1114)
      
      
      191. Iopamidol (1115)
      
      
      192. Irinotecan hydrochloride trihydrate (2675)
      
      
      193. Isoprenaline sulfate (0502)
      
      
      194. Isopropyl alcohol (0970)
      
      
      195. Isopropyl myristate (0725)
      
      
      196. Isopropyl palmitate (0839)
      
      
      197. Isosorbide dinitrate, diluted (1117)
      
      
      198. Isoxsuprine hydrochloride (1119)
      
      
      199. Kanamycin acid sulfate (0033)
      
      
      200. Kanamycin monosulfate (0032)
      
      
      201. Labetalol hydrochloride (0923)
      
      
      202. Lactose (1061)
      
      
      203. Leuprorelin (1442)
      
      
      204. Levocabastine hydrochloride (1484)
      
      
      205. Lincomycin hydrochloride (0583)
      
      
      206. Lomustine (0928)
      
      
      207. Loratadine (2124)
      
      
      208. Lynestrenol (0558)
      
      
      209. Macrogol isotridecyl ether (2730)
      
      
      210. Macrogol lauryl ether (1124)
      
      
      211. Macrogol poly(vinyl alcohol) grafted copolymer (2523)
      
      
      212. Magnesium aspartate dihydrate (1445)
      
      
      213. Magnesium stearate (0229)
      
      
      214. Maize starch (0344)
      
      
      215. Meldonium dihydrate (2624)
      
      
      216. Menadione (0507)
      
      
      217. Mepivacaine hydrochloride (1242)
      
      
      218. Mepyramine maleate (0278)
      
      
      219. Meropenem trihydrate (2234)
      
      
      220. Metacresol (2077)
      
      
      221. Methadone hydrochloride (0408)
      
      
      222. Methanol (1989)
      
      
      223. Methyl salicylate (0230)
      
      
      224. Methylcellulose (0345)
      
      
      225. Methylene chloride (0932)
      
      
      226. N-Methylpyrrolidone (1675)
      
      
      227. Metoclopramide hydrochloride monohydrate (0674)
      
      
      228. Mianserin hydrochloride (0846)
      
      
      229. Minocycline hydrochloride dihydrate (1030)
      
      
      230. Molgramostim concentrated solution (1641)
      
      
      231. Naftidrofuryl hydrogen oxalate (1594)
      
      
      232. Nandrolone decanoate (1992)
      
      
      233. Naphazoline hydrochloride (0730)
      
      
      234. Naphazoline nitrate (0147)
      
      
      235. Neomycin sulfate (0197)
      
      
      236. Neostigmine bromide (0046)
      
      
      237. Neostigmine metilsulfate (0626)
      
      
      238. Netilmicin sulfate (1351)
      
      
      239. Nevirapine hemihydrate (2479)
      
      
      240. Nicardipine hydrochloride (2776)
      
      
      241. Norflurane (2257)
      
      
      242. Nystatin (0517)
      
      
      243. Octyldodecanol (1136)
      
      
      244. Oleyl alcohol (2073)
      
      
      245. Olsalazine sodium (1457)
      
      
      246. Orphenadrine citrate (1759)
      
      
      247. Orphenadrine hydrochloride (1760)
      
      
      248. Oseltamivir phosphate (2422)
      
      
      249. Oxacillin sodium monohydrate (2260)
      
      
      250. Oxeladin hydrogen citrate (1761)
      
      
      251. Oxolinic acid (1353)
      
      
      252. Oxytetracycline dihydrate (0199)
      
      
      253. Oxytocin (0780)
      
      
      254. Oxytocin concentrated solution (0779)
      
      
      255. Paclitaxel (1794)
      
      
      256. Papaverine hydrochloride (0102)
      
      
      257. Pemetrexed disodium heptahydrate (2637)
      
      
      258. Permethrin (25:75) (1762)
      
      
      259. Phentolamine mesilate (1138)
      
      
      260. Phytosterol (1911)
      
      
      261. Piperacillin sodium (1168)
      
      
      262. Piperazine hydrate (0425)
      
      
      263. Poloxamers (1464)
      
      
      264. Polymyxin B sulfate (0203)
      
      
      265. Polyoxypropylene stearyl ether (2602)
      
      
      266. Polysorbate 80 (0428)
      
      
      267. Poly(vinyl acetate) (1962)
      
      
      268. Poly(vinyl acetate) dispersion 30 per cent (2152)
      
      
      269. Potassium clavulanate (1140)
      
      
      270. Potassium dihydrogen phosphate (0920)
      
      
      271. Pramipexole dihydrochloride monohydrate (2416)
      
      
      272. Praziquantel (0855)
      
      
      273. Propanol (2036)
      
      
      274. Propofol (1558)
      
      
      275. Protirelin (1144)
      
      
      276. Pyrantel embonate (1680)
      
      
      277. Pyridostigmine bromide (1255)
      
      
      278. Pyrrolidone (2180)
      
      
      279. Rabeprazole sodium (2868)
      
      
      280. Rabeprazole sodium hydrate (2331)
      
      
      281. Raltegravir potassium (2887)
      
      
      282. Ranitidine hydrochloride (0946)
      
      
      283. Reserpine (0528)
      
      
      284. Rifamycin sodium (0432)
      
      
      285. Rilmenidine dihydrogen phosphate (2020)
      
      
      286. Rivastigmine hydrogen tartrate (2630)
      
      
      287. Rupatadine fumarate (2888)
      
      
      288. Saccharin (0947)
      
      
      289. Saccharin sodium (0787)
      
      
      290. Salmeterol xinafoate (1765)
      
      
      291. Sertraline hydrochloride (1705)
      
      
      292. Sevoflurane (2269)
      
      
      293. Sildenafil citrate (2270)
      
      
      294. Sitagliptin phosphate monohydrate (2778)
      
      
      295. Sitagliptin tablets (2927)
      
      
      296. Sodium aminosalicylate dihydrate (1993)
      
      
      297. Sodium aurothiomalate (1994)
      
      
      298. Sodium cetostearyl sulfate (0847)
      
      
      299. Sodium cyclamate (0774)
      
      
      300. Sodium hyaluronate (1472)
      
      
      301. Sodium (S)-lactate solution (2033)
      
      
      302. Sodium phenylbutyrate (2183)
      
      
      303. Sodium propionate (2041)
      
      
      304. Sodium stearyl fumarate (1567)
      
      
      305. Solifenacin succinate (2779)
      
      
      306. Somatostatin (0949)
      
      
      307. Somatropin (0951)
      
      
      308. Somatropin concentrated solution (0950)
      
      
      309. Somatropin for injection (0952)
      
      
      310. Somatropin solution for injection (2370)
      
      
      311. Spectinomycin dihydrochloride pentahydrate (1152)
      
      
      312. Spectinomycin sulfate tetrahydrate for veterinary use (1658)
      
      
      313. Spiramycin (0293)
      
      
      314. Starch, hydroxypropyl (2165)
      
      
      315. Starch, hydroxypropyl, pregelatinised (2645)
      
      
      316. Starches, hydroxyethyl (1785)
      
      
      317. Stearyl alcohol (0753)
      
      
      318. Streptokinase concentrated solution (0356)
      
      
      319. Streptomycin sulfate (0053)
      
      
      320. Sufentanil citrate (1269)
      
      
      321. Sulbactam sodium (2209)
      
      
      322. Sulfadimethoxine sodium for veterinary use (2745)
      
      
      323. Sulfaguanidine (1476)
      
      
      324. Sulfamerazine (0358)
      
      
      325. Sulfobutylbetadex sodium (2804)
      
      
      326. Sultamicillin (2211)
      
      
      327. Sultamicillin tosilate dihydrate (2212)
      
      
      328. Sumatriptan succinate (1573)
      
      
      329. Tacalcitol monohydrate (2272)
      
      
      330. Tacrolimus monohydrate (2244)
      
      
      331. Tadalafil (2606)
      
      
      332. Tamsulosin hydrochloride (2131)
      
      
      333. Teriparatide (2829)
      
      
      334. Terpin monohydrate (2940)
      
      
      335. Testosterone decanoate (1736)
      
      
      336. Testosterone enantate (1048)
      
      
      337. Testosterone isocaproate (1737)
      
      
      338. Tetracycline hydrochloride (0210)
      
      
      339. Tetryzoline hydrochloride (2101)
      
      
      340. Thiamazole (1706)
      
      
      341. Thiamine hydrochloride (0303)
      
      
      342. Thiamine nitrate (0531)
      
      
      343. Thiocolchicoside crystallised from ethanol (2896)
      
      
      344. Thiocolchicoside hydrate (2814)
      
      
      345. Thiomersal (1625)
      
      
      346. Tianeptine sodium (2022)
      
      
      347. Tiapride hydrochloride (1575)
      
      
      348. Ticarcillin sodium (0956)
      
      
      349. Tigecycline (2825)
      
      
      350. Tizanidine hydrochloride (2578)
      
      
      351. Tobramycin (0645)
      
      
      352. all-rac-α-Tocopherol (0692)
      
      
      353. RRR-α-Tocopherol (1256)
      
      
      354. all-rac-α-Tocopheryl acetate (0439)
      
      
      355. RRR-α-Tocopheryl acetate (1257)
      
      
      356. α-Tocopheryl acetate concentrate (powder form) (0691)
      
      
      357. DL-α-Tocopheryl hydrogen succinate (1258)
      
      
      358. RRR-α-Tocopheryl hydrogen succinate (1259)
      
      
      359. Tolterodine tartrate (2781)
      
      
      360. Tosylchloramide sodium (0381)
      
      
      361. Tributyl acetylcitrate (1770)
      
      
      362. Tri-n-butyl phosphate (1682)
      
      
      363. Triethyl citrate (1479)
      
      
      364. Trimebutine maleate (2182)
      
      
      365. Trimetazidine dihydrochloride (1741)
      
      
      366. Trimethoprim (0060)
      
      
      367. Trolamine (1577)
      
      
      368. Troxerutin (2133)
      
      
      369. Tuberculin purified protein derivative, avian (0535)
      
      
      370. Tuberculin purified protein derivative, bovine (0536)
      
      
      371. Tylosin for veterinary use (1273)
      
      
      372. Tylosin phosphate for veterinary use (2802)
      
      
      373. Tylosin tartrate for veterinary use (1274)
      
      
      374. Vancomycin hydrochloride (1058)
      
      
      375. Vardenafil hydrochloride trihydrate (2782)
      
      
      376. Vecuronium bromide (1769)
      
      
      377. Vinblastine sulfate (0748)
      
      
      378. Vincristine sulfate (0749)
      
      
      379. Vindesine sulfate (1276)
      
      
      380. Voriconazole (2576)
      
      
      381. Wool alcohols (0593)
      
      
      382. Wool fat (0134)
      
      
      383. Wool fat, hydrogenated (0969)
      
      
      384. Xylitol (1381)
      
      
      385. Ziprasidone mesilate trihydrate (2649)
      
      

TEXTS WHOSE TITLE HAS CHANGED

The titles of the following texts have been changed for the 10th Edition
GENERAL CHAPTERS
2.6.33. Residual pertussis toxin (previously Residual pertussis toxin and irreversibility of pertussis toxoid)

1. MONOGRAPHS
   1. Vaccines for veterinary use
      
      
      1. Enteric redmouth disease vaccine (inactivated) for rainbow trout (1950) (previously Yersiniosis vaccine (inactivated) for salmonids)
      
      
   2. Sutures for human use
      
      
      1. Sutures for human use: introduction (90004) (previouslyIntroduction)
      
      
   3. Herbal drugs and herbal drug preparations
      
      
      1. Herbal drugs: introduction (90029) (previously Introduction)
      
      
   4. Homoeopathic preparations
      
      
      1. Homoeopathic preparations: introduction (90006) (previously Introduction)
      
      

TEXTS WHOSE NUMBERING HAS CHANGED

The numbering of the following texts has been changed for the 10th Edition following the modification of the structure of section 3 and the creation of chapter 3.3. Containers for human blood and blood components, and materials used in their manufacture; transfusion sets and materials used in their manufacture; syringes. Chapter 3.3 contains the following texts, which were previously in chapters 3.1. Materials used for the manufacture of containers and 3.2. Containers.

1. GENERAL CHAPTERS
   1. 3.3.1. Materials for containers for human blood and blood components (previously 3.1.1)
   
   
   2. 3.3.2. Materials based on plasticised poly(vinyl chloride) for containers for human blood and blood components (previously 3.1.1.1)
   
   
   3. 3.3.3. Materials based on plasticised poly(vinyl chloride) for tubing used in sets for the transfusion of blood and blood components (previously 3.1.1.2)
   
   
   4. 3.3.4. Sterile plastic containers for human blood and blood components (previously 3.2.3)
   
   
   5. 3.3.5. Empty sterile containers of plasticised poly(vinyl chloride) for human blood and blood components (previously 3.2.4)
   
   
   6. 3.3.6. Sterile containers of plasticised poly(vinyl chloride) for human blood containing anticoagulant solution (previously 3.2.5)
   
   
   7. 3.3.7. Sets for the transfusion of blood and blood components (previously 3.2.6)
   
   
   8. 3.3.8. Sterile single-use plastic syringes (previously 3.2.8)
   
   

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