Role of Forced Degradation in Stability Indicating Method Development: A Comprehensive Review

Forced degradation studies are a fundamental requirement in pharmaceutical development for establishing stability-indicating analytical methods and ensuring drug product quality throughout its lifecycle. By exposing active pharmaceutical ingredients and formulations to controlled stress conditions such as hydrolytic, oxidative, thermal, photolytic, and humidity stress, forced degradation enables the identification of degradation pathways, characterization of degradation products, and assessment of intrinsic molecular stability. This comprehensive review critically examines the role of forced degradation in stability-indicating method development, with emphasis on regulatory expectations outlined by ICH, FDA, and EMA. Key factors affecting drug stability, types of stability testing, stress study design, analytical techniques for degradation profiling, and method validation parameters are systematically discussed. The review highlights how forced degradation data support impurity qualification, formulation and packaging decisions, shelf-life estimation, and risk-based quality management. Overall, forced degradation studies serve as a cornerstone in assuring pharmaceutical product safety, efficacy, and regulatory compliance.