EP8.8增补内容

EP8.8增补内容  

CONTENTS OF SUPPLEMENT 8.8

EP8.8增补内容

A vertical line in the margin indicateswhere part of a text has been revised or corrected. A horizontal line in themargin indicates where part of a text has been deleted. However, theseindications, which are not necessarily exhaustive, are given for informationand do not form an official part of the texts. Editorial changes are notindicated.

Individual copies of texts will not besupplied.

Subscribers to the current version(printed or electronic) of the European Pharmacopoeia have access to an archiveversion of all previous editions of the European Pharmacopoeia.

NEW TEXTS 新增

The texts below appear for the firsttime in the European Pharmacopoeia. They will be implemented on 1 July2016 at the latest.

MONOGRAPHS 各论

General monographs 通论

Chemical precursors forradiopharmaceutical preparations (2902)

Radiopharmaceutical preparations andstarting materials for radiopharmaceutical preparations

Fluorocholine (18F) injection (2793)

Monographs

Amorolfine hydrochloride (2756)

Escitalopram oxalate (2733)

Hard fat with additives (2731)

Mycophenolate sodium (2813)

REVISED TEXTS 修订内容

The texts below have been technicallyrevised since their last publication. They will be implemented on 1July 2016. 以下内容有技术性修订。自2016年7月1日起生效。

GENERAL CHAPTERS 通用章节

2.2.3. Potentiometric determination ofpH

2.2.46. Chromatographic separationtechniques

2.4.22. Composition of fatty acids bygas chromatography

2.4.32. Total cholesterol in oils richin omega-3 acids

2.6.8. Pyrogens 热源

4. Reagents (new, revised,corrected) 试剂 （新增、修订、纠正）

5.1.10. Guidelines for using the testfor bacterial endotoxins 细菌内毒素测试使用指南

5.3. Statistical analysis of results ofbiological assays and tests 生物含量结果和测试统计分析

5.4. Residual solvents 残留溶剂

MONOGRAPHS

General monographs

Radiopharmaceutical preparations (0125)

Substances for pharmaceutical use (2034)

Herbal drugs and herbal drugpreparations

Dioscorea oppositifolia rhizome (2473)

Ephedra herb (2451)

Schisandra fruit (2428)

Monographs

Alverine citrate (2156)

Cetyl palmitate (1906)

Dextromethorphan hydrobromide (0020)

Dimethylacetamide (1667)

Ergocalciferol (0082)

Ether (0650)

Ether, anaesthetic (0367)

Fenoterol hydrobromide (0901)

Galactose (1215)

Hard fat (0462)

Irbesartan (2465)

Macrogolglycerol hydroxystearate (1083)

Maltodextrin (1542)

Methacrylic acid - ethyl acrylatecopolymer (1:1) (1128)

Methacrylic acid - ethyl acrylatecopolymer (1:1) dispersion 30 per cent (1129)

Methacrylic acid - methyl methacrylatecopolymer (1:1) (1127)

Methacrylic acid - methyl methacrylatecopolymer (1:2) (1130)

Phenobarbital sodium (0630)

Phenoxyethanol (0781)

Pyrantel embonate (1680)

Sodium fluoride (0514)

Sodium glycerophosphate, hydrated (1995)

Ubidecarenone (1578)

Xylitol (1381)

Zopiclone (1060)

CORRECTED TEXTS 纠正内容

The texts below have been corrected andare republished in their entirety. These corrections are to be taken intoaccount from the publication date of Supplement 8.8 (1 January 2016).

MONOGRAPHS

Monographs

Hydroxypropylcellulose, low-substituted(2083)

Hypromellose (0348)

Methylcellulose (0345)

DELETED TEXTS 删除内容

The following text is deleted as of 1April 2016.

MONOGRAPHS

Herbal drugs and herbal drugpreparations

Cinnamon tincture (1819)

The following texts are deleted as of 1January 2016.以下内容自2016年1月1日起删除。

MONOGRAPHS

Immunosera for veterinary use

Clostridium novyi alpha antitoxin forveterinary use (0339)

Clostridium perfringens beta antitoxinfor veterinary use (0340)

Clostridium perfringens epsilonantitoxin for veterinary use (0341)

The following text is deleted as of 1April 2015. 以下内容自2015年4月1日起删除。

MONOGRAPHS

Herbal drugs and herbal drugpreparations

Liquorice ethanolic liquid extract,standardised (1536)

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