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

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, photolytic conditions) are applied to drugs compounds during a process known as forced degradation, result, various products created. The major purpose these investigations is assess molecule's stability under accelerated settings. It well recognized that the molecules affects regulatory documentation process, choice appropriate storage packaging conditions, formulation. deficiencies reported methods in terms requirements highlighted. provide International conference harmonization (ICH) criteria force discuss methodical creating verified SIAMs. aspects Mass balance SIMs discussed technique used were Recent advance indicating include characterization degrdant sample in-vitro toxicity prediction addressed. Background respect international author national discussed.