The importance and the challenges of impurity profiling in modern pharmaceutical analysis

被引:131
作者
Gorog, Sandor [1 ]
机构
[1] Gedeon Richter Chem Works Ltd, H-1475 Budapest, Hungary
关键词
chromatography; drug; impurity; impurity profile; pharmaceutical formulation; spectroscopy;
D O I
10.1016/j.trac.2006.05.011
中图分类号
O65 [分析化学];
学科分类号
070302 ; 081704 ;
摘要
After briefly discussing the role of impurity profiling in the safety of drug therapy, I outline the methodological aspects of this field with emphasis on chromatographic and spectroscopic techniques as well as their hyphenated variants. Finally, I introduce the important branches of drug-impurity profiling, selected for presentation in this Special Issue of TrAC on this topic. (c) 2006 Elsevier Ltd. All rights reserved.
引用
收藏
页码:755 / 757
页数:3
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