TITLE

Chemical and analytical characterization of related organic impurities in drugs

AUTHOR(S)
Görög, Sándor
PUB. DATE
November 2003
SOURCE
Analytical & Bioanalytical Chemistry;Nov2003, Vol. 377 Issue 5, p852
SOURCE TYPE
Academic Journal
DOC. TYPE
Article
ABSTRACT
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.
ACCESSION #
15124776

 

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