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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.
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Dong et al. (1990) studied this question.
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