Vol. 3, Issue 2, Part A (2021)
Review on forced degradation studies
Amol J Giri, P R Tathe, Shubham Adole, O M Thakre, Yugandhar Kahale
The Forced degradation studies show the chemical behavior of the molecule which in turn helps in the development of formulation and package. A forced degradation study is an essential step in the design of a regulatory compliant stability program for both drug substances and products, and formalized as a regulatory requirement in ICH Guideline Q1A in 1993. Forced degradation is a degradation of new drug substance and drug product at conditions more severe than accelerated conditions.
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Amol J Giri, P R Tathe, Shubham Adole, O M Thakre, Yugandhar Kahale. Review on forced degradation studies. Int. J. Pharmacognosy Pharm. Sci. 2021;3(2):16-18.