201408 EP8.5增补/更新内容清单

201408 EP8.5增补/更新内容清单   

2014-08-25 10:13:51|  分类： EP |

原文网址：http://www.edqm.eu/en/List-of-texts-adopted-at-the-June-2014-session-of-the-PhEur-Commission-1587.html?mbID=221

List of texts adopted at the June 2014 session of the European Pharmacopoeia Commission

EP委员会2014年7月会议决定采纳的内容

The following new and revised texts will be published in Supplement 8.5 of the European Pharmacopoeia and implemented on 1 July 2015. Individual copies of texts will not be supplied.

以下新增和修订内容将在EP8.5中公布，2015年7月1日起实施。

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)

Permethrin (25:75) (1762)

Triclabendazole for veterinary use (2609)

REVISED TEXTS

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

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

NEW TEXTS

MONOGRAPHS

General Monographs

Herbal drug extracts (0765)

Vaccines for human use

Hepatitis A (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)

Bitter-orange epicarp and mesocarp (1603)

Fumitory (1869)

Gentian root (0392)

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)

Methionine (1027)

Mianserin hydrochloride (0846)

Miconazole (0935)

Noscapine hydrochloride (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)

多谢提醒！