Liquid Chromatographic Considerations for High Sensitivity Impurity and Stability Testing of Pharmaceuticals
- 1 July 1990
- journal article
- research article
- Published by Taylor & Francis in Journal of Liquid Chromatography
- Vol. 13 (11) , 2135-2160
- https://doi.org/10.1080/01483919008049020
Abstract
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.This publication has 7 references indexed in Scilit:
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