LIQUID-CHROMATOGRAPHIC CONSIDERATIONS FOR HIGH-SENSITIVITY IMPURITY AND STABILITY TESTING OF PHARMACEUTICALS

被引：20

作者：

DONG, MW ^{[1
]}

PASSALACQUA, PV ^{[1
]}

CHOUDHURY, DR ^{[1
]}

机构：

[1] VICKS RES CTR, SHELTON, CT 06484 USA

来源：

JOURNAL OF LIQUID CHROMATOGRAPHY | 1990年 / 13卷 / 11期

关键词：

D O I：

10.1080/01483919008049020

中图分类号：

Q5 [生物化学];

学科分类号：

071010 ; 081704 ;

摘要：

The use of liquid chromatography for purity and stability testing of bulk and formulated pharmaceuticals is reviewed with particular regard to method development and validation. Recently published USP validation guidelines for both the main drug component and its impurities are also discussed with emphasis on the use of high sensitivity diode array detection and modern chromatographic software. Included in the discussion are instrumental factors and operating conditions for optimum analytical performance. © 1990, Taylor & Francis Group, LLC. All rights reserved.

引用

页码：2135 / 2160

页数：26

共 23 条

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