Overview on Development and Validation of Force Degradation Studies with Stability Indicating Methods

Abstract

ABSTRACT: This article provides an overview on Development and Validation of Force degradation study with Stability Indicating Methods (SIMs) for drug substances. Different stress conditions (hydrolysis, oxidation, thermal, and photolytic conditions) are applied to drugs compounds during a process known as forced degradation, and as a result, various degradation products are created. The major purpose of these investigations is to assess a molecule's stability under accelerated settings. It is well recognized that the stability of molecules affects the regulatory documentation process, the choice of appropriate storage and packaging conditions, and the choice of formulation. The deficiencies of reported methods in terms of regulatory requirements are highlighted. This article is to provide appropriate International conference of harmonization (ICH) criteria for force degradation study and to discuss the methodical process for creating verified SIAMs. The aspects of Mass balance in SIMs are discussed and technique used in SIMs were highlighted. Recent advance in stability indicating methods include characterization of degrdant sample and in-vitro toxicity prediction are addressed. Background of force degradation study with stability indicating methods with respect to international author and national author are discussed.