2014-12-04 10:06:45| 分类： EP|
来源：http://zhuyujiao1972.blog.163.com/blog/static/98694727201411410645798/
CONTENTS OF SUPPLEMENT 8.5
EP8.5增补内容
A vertical line in the margin indicates where part of a text has been revised or corrected. A horizontal line in the margin indicates where part of a text has been deleted. However, these indications, which are not necessarily exhaustive, are given for information and do not form an official part of the texts. Editorial changes are not indicated.
Individual copies of texts will not be supplied.
Subscribers to the current version (printed or electronic) of the European Pharmacopoeia have access to an archive version of all previous editions of the European Pharmacopoeia.
NEW TEXTS 新增文件
The texts below appear for the first time in the European Pharmacopoeia. They will be implemented on 1 July 2015 at the latest.
GENERAL CHAPTERS
5.23. Monographs on herbal drug extracts (information chapter)
MONOGRAPHS
Vaccines for human use
Influenza vaccine (live, nasal) (2772)
Radiopharmaceutical preparations and starting materials for radiopharmaceutical preparations
Fluoroethyl-L-tyrosine (18F) injection (2466)
Monographs
Macrogol isotridecyl ether (2730) 聚乙二醇异十三醇醚
Permethrin (25:75) (1762) 百灭宁
Triclabendazole for veterinary use (2609)兽用三氯苯咪唑
REVISED TEXTS 修订文件
The texts below have been technically revised since their last publication. They will be implemented on 1 July 2015.
GENERAL CHAPTERS
2.2.11. Distillation range
2.2.12. Boiling point
2.2.16. Melting point - instantaneous method
2.2.32. Loss on drying 干燥失重
2.5.12. Water : semi-micro determination
2.7.14. Assay of hepatitis A vaccine
2.7.18. Assay of human coagulation factor II
2.9.10. Ethanol content
2.9.34. Bulk density and tapped density of powders
4. Reagents (new, revised, corrected)
MONOGRAPHS
General monographs
Herbal drug extracts (0765)
Vaccines for human use
HepatitisA (inactivated, adsorbed) and typhoid polysaccharide
vaccine (2597)
Hepatitis A (inactivated) and hepatitis B (rDNA) vaccine
(adsorbed) (1526)
Hepatitis A vaccine (inactivated, adsorbed) (1107)
Hepatitis A vaccine (inactivated, virosome) (1935)
Typhoid vaccine (live, oral, strain Ty 21a) (1055)
Herbal drugs and herbal drug preparations
Acacia (0307)
Angelica dahurica root (2556)
Artichoke leaf (1866)
Belladonna leaf dry extract, standardised (1294)
Bitter-orange epicarp and mesocarp (1603)
Frangula bark dry extract, standardised (1214)
Fumitory (1869)
Gentian root (0392)
Senna leaf dry extract, standardised (1261)
Valerian root (0453)
Valerian root, cut (2526)
Monographs
Acarbose (2089)
Articaine hydrochloride (1688)
Benzocaine (0011)
Bufexamac (1179)
Glutathione (1670)
Glycine (0614)
Interferon alfa-2 concentrated solution (1110)
Isopropyl alcohol (0970)
Meloxicam (2373)
Mianserin hydrochloride (0846)
Miconazole (0935)
Noscapine hydrochloride hydrate (0515)
Polysorbate 20 (0426)
Polysorbate 40 (1914)
Polysorbate 60 (0427)
Poly(vinyl acetate) (1962)
Prazepam (1466)
Progesterone (0429)
Rifaximin (2362)
Selamectin for veterinary use (2268)
Sulbactam sodium (2209)
CORRECTED TEXTS 改正的文件
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 8.5 (1 January 2015).
MONOGRAPHS
Herbal drugs and herbal drug preparations
Opium dry extract, standardised (1839)
Opium, prepared (1840)
Opium, raw (0777)
Opium tincture, standardised (1841)
Monographs
Alfadex (1487)
Betadex (1070)
Ethanol (96 per cent) (1317)
Ethanol, anhydrous (1318)
Lufenuron (anhydrous) for veterinary use (2177)
Poloxamers (1464)
TEXTS WHOSE TITLE HAS CHANGED 题目变更的文件
The titles of the following texts have been changed in Supplement 8.5.
MONOGRAPHS
General monographs
Herbal drug extracts (0765) (previously Extracts)
Monographs
Noscapine hydrochloride hydrate (0515) (previously Noscapine hydrochloride)
DELETED TEXTS 删除的文件
The following text is deleted as of 1 April 2015.
MONOGRAPHS
Monographs
Liquorice ethanolic liquid extract, standardised (1536)
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