Forced Degradation – A Review

Abstract

Forced degradation is the breakdown of a novel drug substance and product under more severe instances than escalated degradation. It is necessary to illustrate the accuracy of stability-indicating approaches, as well as provide insight into the drug substance's degradation pathways and degradation products and aid in the clarification of the configuration of the degradation products. Forced degradation investigations reveal the chemical behaviour of the molecule, which aids in the conceptualization and batch development. Furthermore, the governmental instruction is quite vague and excludes any explanation of the findings from research on forced depletion. As a result, this discussion covers the existing routines in the effectiveness of forced degradation studies with an approach to perform studies on degradation mechanisms, as well as the analytical methods useful for the development of stability-indicating methods.