A Review on Force Degradation Studies for Drug Substances

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 or alternatively referred as stress testing and it demonstrates specificity when developing stability indicating methods, especially when little is known about potential degradation products. Forced degradation study provides information about the degradation pathways and degradation products of the drug substance that could form during storage, transportation. Force degradation study also 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 provides knowledge of the current trends in performance of forced degradation study and establishing the analytical methods that helpful for development of stability indicating method.