201408 EP8.5增补/更新内容清单 2014-08-25 10:13:51| 分类： EP |
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)