位置：
歐洲藥典8 EP8(歐洲藥典第9版已經(jīng)出版發(fā)行，2017年1月生效)
◇ 2013年7月出版;
◇ 2014年1月生效。
各增補(bǔ)版的出版日期及執(zhí)行的日期。
最初的兩卷包括第7版完整的內(nèi)容，以及歐洲藥典委員會在2012年12月全會上通過或修訂的內(nèi)容，共收載了2224個個論，345個含插圖或色譜圖的總論，以及2500種試劑的說明。變化的內(nèi)容（插入或刪除的內(nèi)容）在頁邊標(biāo)注出
自2014年1月起，在歐洲藥典成員國，包括歐盟國家，將執(zhí)行第8版并取代第7版。第7版至12月31日都是有效的。歐洲藥典有英文版與法文版，英語與法語是歐洲委員會的官方語言。歐洲藥典有印刷版、USB閃存版和在線版。其西班牙文版正在翻譯之中，將來包括在在線版中，不再另收取費用。
歐洲藥典：
一部藥品與藥用物質(zhì)的標(biāo)準(zhǔn)
歐洲藥典是歐洲藥品質(zhì)量控制的標(biāo)準(zhǔn)。已有多項法律文件使歐洲藥典成為法定標(biāo)準(zhǔn)：
2009年經(jīng)36個歐洲國家和歐盟批準(zhǔn)的編撰歐洲藥典協(xié)議；
關(guān)于人用或獸用藥品的歐盟指令2001/82/EC、2001/83/EC（修正案）和2003/63/EC，維持了歐洲藥典對在歐洲上市藥品的強(qiáng)制執(zhí)行性。這些標(biāo)準(zhǔn)規(guī)定了藥品、生產(chǎn)用原材料與合成用中間體成份的定性、定量和所用的檢驗項目。所有藥品、藥用物質(zhì)生產(chǎn)企業(yè)在歐洲銷售或使用其產(chǎn)品時，都必須遵循歐洲藥典標(biāo)準(zhǔn)。
歐洲藥典的內(nèi)容具有法律約束力，由行政管理或司法部門強(qiáng)制要求符合歐洲藥典。成員國的國家當(dāng)局必須采用歐洲藥典，必要時可替代相同物質(zhì)國家標(biāo)準(zhǔn)中的個論。
歐洲藥典的內(nèi)容包括活性物質(zhì)、輔料、化學(xué)、動物、人或植物來源的藥用物質(zhì)或制品、順勢療法制劑和順勢療法原料、抗生素，以及制劑和容器等。
歐洲藥典還適用于生物制品、血液和血漿制品、疫苗和放射藥品。
歐洲藥典8 EP8相關(guān)內(nèi)容
NEW TEXTS
The texts below appear for the first time in the European Pharmacopoeia. They will be implemented on 1 January 2016 at the latest.
MONOGRAPHS
Radiopharmaceutical preparations and starting materials for radiopharmaceutical preparations Copper tetramibi tetrafluoroborate for radiopharmaceutical
preparations (2547)
Herbal drugs and herbal drug preparations
Anemarrhena asphodeloides rhizome (2661)
Hamamelis bark (2532)
Indigo plant leaf (2727)
Homoeopathic preparations
Belladonna for homoeopathic preparations (2489)
Petroleum rectificatum for homoeopathic preparations (2683)
Staphysagria for homoeopathic preparations (2289)
Monographs
Exemestane (2766)
Nicorandil (2332)
Pirfenidone (2856)
Sodium selenite (2740)
Solifenacin succinate (2779)
Somatropin solution for injection (2370)
REVISED TEXTS
The texts below have been technically revised since their last publication. They will be implemented on 1 January 2016.
GENERAL CHAPTERS
2.2.4. Approximate pH of solutions
2.2.19. Amperometric titration
2.2.20. Potentiometric titration
2.2.34. Thermal analysis
2.2.36. Potentiometric determination of ionic concentration using ion-selective electrodes
2.4.29. Composition of fatty acids in oils rich in omega-3 acids
2.5.5. Peroxide value
2.5.32. Water: micro determination
2.9.3. Dissolution test for solid dosage forms
2.9.40. Uniformity of dosage units
4. Reagents (new, revised, corrected)
5.2.4. Cell cultures for the production of veterinary vaccines
5.8. Pharmacopoeial harmonisation
5.22. Names of herbal drugs used in traditional Chinese medicine
MONOGRAPHS
Vaccines for veterinary use Brucellosis vaccine (live) (Brucella melitensis Rev. 1 strain) for
veterinary use (0793)
Radiopharmaceutical preparations and starting materials
for radiopharmaceutical preparations
Pentetate sodium calcium for radiopharmaceutical
preparations (2353)
Technetium (99mTc) medronate injection (0641)
Herbal drugs and herbal drug preparations
Benzoin, Siam (2158)
Bilberry fruit, dried (1588)
Bilberry fruit, fresh (1602)
Centella (1498)
Fresh bilberry fruit dry extract, refined and standardised (2394)
Ginseng (1523)
Java tea (1229)
Homoeopathic preparations
Methods of preparation of homoeopathic stocks and potentisation (2371)
Monographs
Aluminium phosphate, hydrated (1598)
Amidotrizoic acid dihydrate (0873)
Amiloride hydrochloride dihydrate (0651)
Amlodipine besilate (1491)
Anticoagulant and preservative solutions for human blood (0209)
Aprotinin (0580)
Aprotinin concentrated solution (0579)
Bromhexine hydrochloride (0706)
Buserelin (1077)
Carbomers (1299)
Carnauba wax (0597)
Chymotrypsin (0476)
Crospovidone (0892)
Demeclocycline hydrochloride (0176)
Dihydralazine sulfate, hydrated (1310)
Diphenhydramine hydrochloride (0023)
Dithranol (1007)
Doxapram hydrochloride (1201)
Filgrastim concentrated solution (2206)
Fluticasone propionate (1750)
Fructose (0188)
Fulvestrant (2443)
Galactose (1215)
Glimepiride (2223)
Glucose, anhydrous (0177)
Glucose monohydrate (0178)
Hexylresorcinol (1437)
Human coagulation factor IX (rDNA) concentrated solution (2522)
Hypromellose (0348)
Iopanoic acid (0700)
Ioxaglic acid (2009)
Isoleucine (0770)
Lactose, anhydrous (1061)
Lactose monohydrate (0187)
Leucine (0771)
Lysine hydrochloride (0930)
Methionine (1027)
Methylcellulose (0345)
Methylprednisolone acetate (0933)
Methylprednisolone hydrogen succinate (1131)
Methylthioninium chloride (1132)
Naftidrofuryl hydrogen oxalate (1594)
Nicotinamide (0047)
Orphenadrine citrate (1759)
Orphenadrine hydrochloride (1760)
Oxeladin hydrogen citrate (1761)
Oxolinic acid (1353)
Pancreas powder (0350)
Phenazone (0421)
Phentolamine mesilate (1138)
Polysorbate 80 (0428)
Potassium hydroxide (0840)
Povidone, iodinated (1142)
Propylene glycol dicaprylocaprate (2122)
Quinidine sulfate (0017)
Quinine hydrochloride (0018)
Quinine sulfate (0019)
Risedronate sodium 2.5-hydrate (2572)
Rivastigmine hydrogen tartrate (2630)
Sodium amidotrizoate (1150)
Sodium hydroxide (0677)
Sodium nitroprusside (0565)
Sodium selenite pentahydrate (1677)
Spirapril hydrochloride monohydrate (1766)
Sucrose (0204)
Sugar spheres (1570)
Sulfacetamide sodium (0107)
Theophylline-ethylenediamine hydrate (0301)
Thiamine hydrochloride (0303)
Thiamine nitrate (0531)
Thiamphenicol (0109)
Tribenoside (1740)
Trypsin (0694)
CORRECTED TEXTS
The texts below have been corrected and are republished in their entirety. These corrections are to be taken into account from the publication date of Supplement 8.6 (1 July 2015), unless otherwise indicated.
GENERAL CHAPTERS
2.4.22. Composition of fatty acids by gas chromatography
2.5.1. Acid value
2.7.14. Assay of hepatitis A vaccine
2.8.13. Pesticide residues
5.7. Table of physical characteristics of radionuclides mentioned in the European Pharmacopoiea
MONOGRAPHS
Radiopharmaceutical preparations and starting materials for radiopharmaceutical preparations
Gallium (68Ga) edotreotide injection (2482)
Monographs
Cimetidine (0756)
Cimetidine hydrochloride (1500)
Flucytosine (0766)
Goserelin (1636)
Human antithrombin III concentrate (0878)(1)
Insulin, bovine (1637)
Insulin, human (0838)
Insulin, porcine (1638)
Insulin preparations, injectable (0854)
Isomalt (1531)
Miconazole nitrate (0513)
Nitric acid (1549)
Oxaliplatin (2017)
Polyoxypropylene stearyl ether (2602)
HARMONISED TEXTS
The texts below have undergone pharmacopoeial harmonisation (see chapter 5.8. Pharmacopoeial harmonisation).
GENERAL CHAPTERS
2.2.34. Thermal analysis
2.9.3. Dissolution test for solid dosage forms
2.9.40. Uniformity of dosage units
MONOGRAPHS
Monographs
Crospovidone (0892)
Glucose, anhydrous (0177)
Glucose monohydrate (0178)
Hypromellose (0348)
Methylcellulose (0345)
Polysorbate 80 (0428)
TEXTS WHOSE TITLE HAS CHANGED
The titles of the following texts have been changed in Supplement 8.6.
GENERAL CHAPTERS
2.2.4. Approximate pH of solutions (previously Relationship between reaction of solution, approximate pH and colour of certain indicators)
MONOGRAPHS
Monographs
Amiloride hydrochloride dihydrate (0651) (previously Amiloride hydrochloride)
DELETED TEXTS
The following texts are deleted as of 1 January 2016.
MONOGRAPHS
Immunosera for veterinary use
Clostridium novyi alpha antitoxin for veterinary use (0339)
Clostridium perfringens beta antitoxin for veterinary use (0340)
Clostridium perfringens epsilon antitoxin for veterinary use (0341)
The following text is deleted as of 1 April 2015.
MONOGRAPHS
Monographs
Liquorice ethanolic liquid extract, standardised (1536)
訂購 歐洲藥典
| 版本 | 貨期 | 生效日期 | 價格 |
| 歐洲藥典8[2卷]及增補(bǔ)1、2 [印刷/英文] | 現(xiàn)貨 | 2014年1月 | ￥4950.00 |
| 歐洲藥典8 增補(bǔ)3、增補(bǔ)4、增補(bǔ)5 [印刷/英文] | 現(xiàn)貨 | 2014年4月 | ￥4950.00 |
| 歐洲藥典8.3、8.4、8.5 [U盤/英文/含8.0-8.2內(nèi)容] | 現(xiàn)貨 | 2014年4月 | ￥4950.00 |
| 歐洲藥典8.6、8.7、8.8 [U盤/英文/含8.0-8.5內(nèi)容] | 現(xiàn)貨 | 2016年1月 | ￥4950.00 |
歐洲藥典官方網(wǎng)站：http://www.edqm.eu/