Görög Sándor
Chemical Works of Gedeon Richter Ltd., P.O.B. 27, 1475, Budapest, Hungary.
Anal Bioanal Chem. 2003 Nov;377(5):852-62. doi: 10.1007/s00216-003-2140-6. Epub 2003 Aug 23.
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.
本文提出了一种用于药物及药品中相关有机杂质分类的系统，其中包括（分离的和未分离的）中间体、各类副产物，不同副反应的产物、差向异构体/非对映异构体、对映体杂质、天然产物中的杂质，以及最终的降解产物。实例主要取自作者自身经验以及欧洲药典中所列杂质，重点是氢化可的松、泼尼松龙、马来酸依那普利、赖诺普利、炔诺二醇二乙酸酯、哌库溴铵、西咪替丁和乙炔基甾体中的杂质。简要总结了从杂质检测到鉴定/结构解析以及杂质定量测定的杂质概况分析方法。
