Chemical and analytical characterization of related organic impurities in drugs

被引：50

作者：

Görög, S ^{[1
]}

机构：

[1] Gedeon Richter Chem Works Ltd, Chem Works, H-1475 Budapest, Hungary

来源：

ANALYTICAL AND BIOANALYTICAL CHEMISTRY | 2003年 / 377卷 / 05期

关键词：

impurity profiling; hydrocortisone; prednisolone; enalapril maleate; lisinopril; ethynodiol diacetate; pipecuronium bromide; cimetidine; ethynylsteroids;

D O I：

10.1007/s00216-003-2140-6

中图分类号：

Q5 [生物化学];

学科分类号：

071010 ; 081704 ;

摘要：

A system is proposed for the classification of related organic impurities in drugs and drug products including among others (separated and non-separated) intermediates, various kinds of by-products, among them products of different side reactions, epimeric/diastereomeric, enantiomeric impurities, impurities in natural products, and finally degradation products. Examples are taken mainly from the author's own experience and from among the named impurities in the European Pharmacopoeia with focus on impurities in hydrocortisone, prednisolone, enalapril maleate, lisinopril, ethynodiol diacetate, pipecuronium bromide, cimetidine, and ethynylsteroids. The methodological aspects of impurity profiling from the detection to the identification/structure elucidation and quantitative determination of impurities are briefly summarized.

引用

页码：852 / 862

页数：11

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