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Stability Indicating Forced Degradation Studies
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Forced degradation study (FD) studies (stress testing) are an intrinsic part of pharmaceutical product development. It is procedure whereby the natural degradation rate of a product or material is increased by the application of additional stress condition. It manifests chemical behaviour of the molecule which helps in the development of formulation and packaging of pharmaceutical development. It is necessary to specify the specificity of the stability indication methods and provide insight into degradation pathways and degradation products of the drug substance and aid in an elucidation of the structure of the degradation products. This review discusses the regulatory aspects of force degradation and the study of stability and also the analytical hyphenated methods used for the development of the forced degradation study.
Keywords
Forced Degradation, Regulatory Aspects, Degradation Products.
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