This study summarizes the development and validation of stability-indicating assay methods (SIAMs). A systematic\r\napproach for the development and validation of stability-indicating methods is discussed. Forced degradation is also discussed\r\nto some extent which is a powerful tool used routinely in pharmaceutical development in order to develop stability indicating\r\nmethods that lead to quality stability data and to understand the degradation pathways of the drug substances and drug\r\nproducts. Force degradation studies ensure appropriate stability of final pharmaceutical products in very early stages of\r\npharmaceutical development. This article describes how to develop a stability indicating method and their regulatory aspect.
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