A review article – development of forced degradation and stability indicating studies for drug substance and drug product
Journal Title: International Journal of Research in Pharmacology & Pharmacotherapeutics (IJRPP) - Year 2016, Vol 5, Issue 4
Abstract
The objective of the review article is to give detailed description and guidance of the forced degradation studies as per regulatory guidelines. Forced degradation study provide information about the degradation pathways and degradation products of the drug substance and helps in the elucidation of the structure of the degradation products. forced degradation study provide the chemical behaviour and chemical nature of the molecule which ultimately helps in the development of formulation during manufacturing and packaging specification, thus this review article provide knowledge of the current trends in performance of forced degradation study and establishing the analytical methods that helpful for development of stability indicating method. The stability of drug product and or drug substance is a critical parameter which may affect purity, potency and safety
Authors and Affiliations
Khushbu A. Thakor
Keywords
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