Anal 2002

This write-up provides a review on the development of validated stability-indicating assay methods SIAMs for drug substances and products. The shortcomings of reported methods with respect to regulatory requirements are highlighted. A systematic approach for the development of stability-indicating methods is discussed. Critical issues related to development of SIAMs, such as separation of all degradation products, establishment of mass balance, stress testing of formulations, development of SIAMs for combination products, etc. The applicability of pharmacopoeial methods for the analysis of stability samples is discussed.

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