Abstract Force degradation studies or stress testing are commonly employed in pharmaceutical industries in order to develop a stability indicating method (SIM). In forced degradation studies, drug substance (API) or a drug product is subjected to various extremities of pH, humidity, hydrolysis and oxidation, photolytic and thermal conditions which in turn produce various degrading products known as degradants. This gives an understanding about the degradation pathways of drug substance and drug products. International Conference on Harmonization (ICH) guidelines Q1A, Q1B, Q2B, Q3A and Q3B regulate the certain conditions of pH, light, oxidation, acid-base hydrolysis, dry heat etc. for carrying out the stress testing. Forced degradation studies exploit the chemical structure of a molecule thereby helping in development of the product formulation, manufacturing and packaging. The studies ensure the appropriate stability of final pharmaceutical products in initial stages of pharmaceutical development. The present review article discusses about various regulatory aspects, methodology for forced degradation studies, various factors affecting the stress decomposition and also about the analytical methods helpful for development of stability indicating method.
Keywords Forced Degradation Studies, Stability Indicating Method, ICH Guidelines, Stress Testing.