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[依据灵活的药典说明对药品及药物制剂进行纯度检测]

[The purity testing of drugs and drug preparations according to flexible pharmacopoeia instructions].

作者信息

Richter J, Sachweh H, Wagler M

出版信息

Pharmazie. 1985 May;40(5):323-4.

PMID:4034635
Abstract

It is well known, that the quality standards of the various pharmacopoeias are based on certain procedures of synthesis or preparation concerning the drugs. Altering the manufacturing methods or importing these drugs from different producers, it may arise that the examined substance will formally come up to the quality directions of the pharmacopoeia agreed upon, but will contain possible, critical contaminations which are beyond the pharmacopoeia directions of examinations.

摘要

众所周知,各种药典的质量标准是基于有关药物的某些合成或制备程序制定的。改变生产方法或从不同生产商进口这些药物时,可能会出现这样的情况:被检测的物质在形式上符合商定的药典质量标准,但可能含有超出药典检测标准的潜在关键污染物。

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