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A REVIEW ON FORCED DEGRADATION AND STABILITY INDICATING STUDIES

G. Indira Priyadarshini*, G. Anjani

Forced degradation is a process in which different stress conditions are applied over drug substances and which turn different degradation products are produced Forced degradation studies show the chemical behavior of the molecule which in turn helps in the development of formulation and package. Forced degradation is a powerful tool used routinely in pharmaceutical development in order to develop stability indicating methods that lead to quality stability data and to understand the degradation pathways of the drug substances and drug products. ICH guidelines demonstrate certain degradation conditions like light, oxidation, dry heat, acidic, basic, hydrolysis etc. ICH Q1A, QIB and Q2B exemplify the forced degradation studies. Key words: Forced degradation, stress conditions, drug substances, drug product and ICH guidelines.

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