Analytical methodologies for discovering and profiling degradation-related impurities

被引：49

作者：

Baertschi, Steven W. ^{[1
]}

机构：

[1] Eli Lilly & Co, Analyt Sci Res & Dev, Indianapolis, IN 46285 USA

来源：

TRAC-TRENDS IN ANALYTICAL CHEMISTRY | 2006年 / 25卷 / 08期

关键词：

analytical technology; chemistry-oriented; degradation pathway; degradation product; degradation-related impurity; detector; DRI; forced degradation; impurity; method development; profiling; stability; stability indicating; stress testing; structure elucidation; technique-oriented;

D O I：

10.1016/j.trac.2006.05.012

中图分类号：

O65 [分析化学];

学科分类号：

070302 ; 081704 ;

摘要：

The analytical technologies currently in use for profiling degradation-related impurities (DRIs) are powerful, but not without their limitations. This article critically assesses the technologies, their strengths and limitations, and recommends strategies for successful DRI profiling. Improvements in analytical separations and detection technologies are leading to strategies involving multiple orthogonal separations and detectors. Advances in knowledge of degradation chemistry and in computer-prediction tools are needed for the future. (c) 2006 Elsevier Ltd. All rights reserved.

引用

页码：758 / 767

页数：10

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