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.
Amol J Giri, P R Tathe, Shubham Adole, O M Thakre, Yugandhar Kahale. Review on forced degradation studies. International Journal of Pharmacognosy and Pharmaceutical Sciences, Volume 3, Issue 2, 2021, Pages 16-18