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.
各增補(bǔ)版的出版日期及執(zhí)行的日期。
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.
2.6.35. Quantification and characterisation of residual host-cell DNA
2.9.49. Powder flow properties by shear cell methods
2.9.52. Scanning electron microscopy
3.3. Containers for human blood and blood components,and materials used in their manufacture; transfusion sets and materials used in their manufacture; syringes
5.25. Process analytical technology
Infectious pancreatic necrosis vaccine (inactivated,oil-adjuvanted, injectable) for salmonids (3063)
Abelmoschi corolla (2827)
Serratula coronata herb (2754)
Benzydamine hydrochloride (2759)
Cocoa butter (2607)
Octreotide (2414)
Prasugrel hydrochloride (3040)
Squalene (2805)
Tapentadol hydrochloride (3035)
Tetracaine (2909)
Topiramate (2616)
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.
2.2.25. Absorption spectrophotometry, ultraviolet and visible
2.6.8. Pyrogens
2.6.33. Residual pertussis toxin
2.7.2. Microbiological assay of antibiotics
2.7.23. Numeration of CD34/CD45+ cells in haematopoietic products
5.8. Pharmacopoeial harmonisation
2.7.35. Immunonephelometry for vaccine component assay
2.8.25. High-performance thin-layer chromatography of herbal drugs and herbal drug preparations
Diphtheria, tetanus, pertussis (acellular, component),hepatitis B (rDNA), poliomyelitis (inactivated) and haemophilus type b conjugate vaccine (adsorbed) (2067)
Diphtheria, tetanus, pertussis (acellular, component),poliomyelitis (inactivated) and haemophilus type b conjugate vaccine (adsorbed) (2065)
Influenza vaccine (surface antigen, inactivated, prepared in cell cultures) (2149)
Influenza vaccine (whole virion, inactivated, prepared in cell cultures) (2308)
Enteric redmouth disease vaccine (inactivated) for rainbow trout (1950)
Enteric redmouth disease vaccine (inactivated) for rainbow trout (1950)
Botulinum antitoxin (0085)
Indigo plant leaf (2727)
Alfacalcidol (1286)
Aluminium magnesium silicate (1388)
Anticoagulant and preservative solutions for human blood (0209)
Apomorphine hydrochloride hemihydrate (0136)
Arachis oil, hydrogenated (1171)
Benserazide hydrochloride (1173)
Biotin (1073)
Boldine (2971)
Borage (starflower) oil, refined (2105)
Caffeine (0267)
Caffeine monohydrate (0268)
Candesartan cilexetil (2573)
Carmellose sodium (0472)
Carmellose sodium, low-substituted (1186)
Carmustine (1187)
Castor oil, hydrogenated (1497)
Castor oil, refined (2367)
Castor oil, virgin (0051)
Cellulose, microcrystalline (0316)
Cetyl palmitate (1906)
Chlorpromazine hydrochloride (0475)
Chlortalidone (0546)
Cholesterol for parenteral use (2397)
Cod-liver oil (type A) (1192)
Cod-liver oil (type B) (1193)
Copovidone (0891)
Cottonseed oil, hydrogenated (1305)
Croscarmellose sodium (0985)
Desipramine hydrochloride (0481)
Diacerein (2409)
Diethylene glycol palmitostearate (1415)
Ethylene glycol monopalmitostearate (1421)
Evening primrose oil, refined (2104)
Fenoterol hydrobromide (0901)
Fish oil, rich in omega-3 acids (1912)
Follitropin (2285)
Follitropin concentrated solution (2286)
Galactose (1215)
Galantamine hydrobromide (2366)
Gelatin (0330)
Glycerol dibehenate (1427)
Glycerol distearate (1428)
Glycerol monostearate 40-55 (0495)
Gonadotrophin, chorionic (0498)
Hard fat (0462)
Hard fat with additives (2731)
Heparin calcium (0332)
Heparin sodium (0333)
Human measles immunoglobulin (0397)
Human plasma for fractionation (0853)
Human plasma (pooled and treated for virus inactivation) (1646)
Imidacloprid for veterinary use (2924)
Infliximab concentrated solution (2928)
Irbesartan (2465)
Lauromacrogol 400 (2046)
Levodropropizine (1535)
Losartan potassium (2232)
Macrogol 15 hydroxystearate (2052)
Macrogol 30 dipolyhydroxystearate (2584)
Mesterolone (1730)
Olmesartan medoxomil (2600)
Oxytetracycline hydrochloride (0198)
Palmitic acid (1904)
Penicillamine (0566)
Phenylpropanolamine hydrochloride (0683)
Phytomenadione, racemic (3011)
Propranolol hydrochloride (0568)
Propyl gallate (1039)
Propylene glycol monopalmitostearate (1469)
Protamine sulfate (0569)
Pyridoxine hydrochloride (0245)
Safflower oil, refined (2088)
Sodium starch glycolate (type A) (0983)
Sodium starch glycolate (type B) (0984)
Sodium starch glycolate (type C) (1566)
Solutions for organ preservation (1264)
Soya-bean oil, hydrogenated (1265)
Soya-bean oil, refined (1473)
Squalane (1630)
Sucralfate (1796)
Terbutaline sulfate (0690)
Tilidine hydrochloride hemihydrate (1767)
Triglycerides, medium-chain (0868)
Urofollitropin (0958)
Urokinase (0695)
Valsartan (2423)
Vigabatrin (2305)
Vinorelbine tartrate (2107)
Wheat starch (0359)
Wheat-germ oil, refined (1379)
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 notices
2.2.5. Relative density
2.2.29. Liquid chromatography
2.2.31. Electrophoresis
2.4.23. Sterols in fatty oils
2.4.25. Ethylene oxide and dioxan
2.4.26. N,N-Dimethylaniline
2.4.32. Total cholesterol in oils rich in omega-3 acids
2.5.19. O-Acetyl in polysaccharide vaccines
2.5.37. Methyl, ethyl and isopropyl methanesulfonate in methanesulfonic acid
2.5.38. Methyl, ethyl and isopropyl methanesulfonate in active substances
2.5.39. Methanesulfonyl chloride in methanesulfonic acid
2.5.40. Methyl, ethyl and isopropyl toluenesulfonate in active substances
2.5.41. Methyl, ethyl and isopropyl benzenesulfonate in active substances
2.7.8. Assay of tetanus vaccine (adsorbed)
2.8.9. Residue on evaporation of essential oils
2.9.10. Ethanol content
2.9.11. Test for methanol and 2-propanol
3.1.14. Materials based on plasticised poly(vinyl chloride) for containers for aqueous solutions for intravenous infusion
3.2. Containers
5.1.2. Biological indicators and related microbial preparations used in the manufacture of sterile products
5.1.6. Alternative methods for control of microbiological quality
5.2.12. Raw materials of biological origin for the production of cell-based and gene therapy medicinal products
5.9. Polymorphism
5.10. Control of impurities in substances for pharmaceutical use
5.12. Reference standards
5.15. Functionality-related characteristics of excipients
5.16. Crystallinity
Chemical precursors for radiopharmaceutical preparations (2902)
Immunosera for human use, animal (0084)
Immunosera for veterinary use (0030)
Live biotherapeutic products for human use (3053)
Vaccines for human use (0153)
Vaccines for veterinary use (0062)
Ear preparations (0652)
Eye preparations (1163)
Intramammary preparations for veterinary use (0945)
Liquid preparations for cutaneous application (0927)
Nasal preparations (0676)
Parenteral preparations (0520)
Rectal preparations (1145)
Semi-solid preparations for cutaneous application (0132)
Vaginal preparations (1164)
Anthrax vaccine for human use (adsorbed, prepared from culture filtrates) (2188)
Diphtheria and tetanus vaccine (adsorbed) (0444)
Diphtheria and tetanus vaccine (adsorbed, reduced antigen(s) content) (0647)
Diphtheria, tetanus and pertussis (whole cell) vaccine (adsorbed) (0445)
Tuberculin purified protein derivative, avian (0535)
Tuberculin purified protein derivative, bovine (0536)
Tylosin for veterinary use (1273)
Tylosin phosphate for veterinary use (2802)
Tylosin tartrate for veterinary use (1274)
Vancomycin hydrochloride (1058)
Vardenafil hydrochloride trihydrate (2782)
Vecuronium bromide (1769)
Vinblastine sulfate (0748)
Vincristine sulfate (0749)
Vindesine sulfate (1276)
Voriconazole (2576)
Wool alcohols (0593)
Wool fat (0134)
Wool fat, hydrogenated (0969)
Xylitol (1381)
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)
Enteric redmouth disease vaccine (inactivated) for rainbow trout (1950) (previously Yersiniosis vaccine (inactivated) for salmonids)
Sutures for human use: introduction (90004) (previouslyIntroduction)
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.
3.3.1. Materials for containers for human blood and blood components (previously 3.1.1)
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. 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)
3.3.4. Sterile plastic containers for human blood and blood components (previously 3.2.3)
3.3.5. Empty sterile containers of plasticised poly(vinyl chloride) for human blood and blood components (previously 3.2.4)
3.3.6. Sterile containers of plasticised poly(vinyl chloride) for human blood containing anticoagulant solution (previously 3.2.5)
3.3.7. Sets for the transfusion of blood and blood components (previously 3.2.6)