CONTENTS OF SUPPLEMENT 8.5

EP8.5增补内容

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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)