我怎么能知道欧洲药典修订的原因呢?
How can I find out why revisions were made to the European Pharmacopoeia?
欧洲药典的文本和专著是BP的组成部分。
The texts and monographs of the European Pharmacopoeia form an integral part of the BP.
我是否需要验证欧洲药典里公布的分析方法?
Do I need to validate a method that is published in the Ph. Eur. ?
欧洲药典各论在欧洲药典所有成员国内均有效。
The European Pharmacopoeiamonographs are valid in all the Member States of the European Pharmacopoeia.
凡例的内容适用于各论和欧洲药典中的其它章节。
The General Notices apply to all monographs and other texts of the European Pharmacopoeia.
回答:usp方法的主要来源是《欧洲药典》方法。
USP's primary source for these methods is the European Pharmacopeia (EP) method.
不需要。欧洲药典各论在欧洲药典所有成员国内均有效。
No. The European Pharmacopoeia monographs are valid in all the Member States of the European Pharmacopoeia.
这个章节的部分与欧洲药典和日本药典的相应内容统一。
Portions of this general chapter have been harmonized with the corresponding texts of the European Pharmacopoeia and the Japanese Pharmacopoeia.
这句话应译为:总体概述适用于欧洲药典中所有的专论以及其它的正文。
The General Notices apply to all monographs and other texts of the European Pharmacopoeia.
如果我按照欧洲药典各论对物质进行了分析,我还需要证明符合国家各论吗?
If I analyse a substance according to a Ph. Eur. monograph, do I also need to demonstrate compliance with the national monograph?
文章详细对比了美国药典1223和欧洲药典5.1.6对于微生物替代法验证要求的异同。
The authors compared the validation requirements for alternative microbiological methods between USP 1223 and Ph Eur 5.1.6 in detail.
纯化水由一经过验证的水纯化系统制备,每隔7天取样一次,并按欧洲药典纯化水规格进行检测。
Purified Water is prepared by a validated water purification system. Purified water is sampled at an interval of 7 days and tested according to Ph. Eur purified water specifications.
研究了影响酯化率与成环率的主要因素,控制合适的酯化、解聚和纯化条件,得到的依诺肝素钠成品符合欧洲药典标准。
Major factors that affected the degree of esterification and 1,6-anhydro ring formation were studied to produce the title compound which met the European Pharmacopoeia standard.
目的了解中、美、英、日和欧洲药典对植物药中重金属和农药残留量的有关规定,为中药材和中成药的质量控制提供参考。
OBJECTIVE To investigate the limit contents for heavy metals and pesticide residues in vegetable drugs from the main pharmacopoeias being used in the world.
欧洲药典以英语和法语形式发行,欧洲药典委员会的签署国可将药典内容译成其它语言,但若发生争议,应以英语和法语版为权威。
States of the European Pharmacopoeia Convention. In case of doubt or dispute, the English and French versions are alone authoritative.
欧洲药典以英语和法语形式发行,欧洲药典委员会的签署国可将药典内容译成其它语言,但若发生争议,应以英语和法语版为权威。
States of the European Pharmacopoeia Convention. In case of doubt or dispute, the English and French versions are alone authoritative.
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