Review on forced degradation studies

Amol J Giri; P R Tathe; Shubham Adole; O M Thakre; Yugandhar Kahale

doi:10.33545/27067009.2021.v3.i2a.30

Review on forced degradation studies

Author(s):

Amol J Giri, P R Tathe, Shubham Adole, O M Thakre, Yugandhar Kahale

Abstract:

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.

DOI: 10.33545/27067009.2021.v3.i2a.30

Pages: 16-18 | 1265 Views 627 Downloads

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International Journal of Pharmacognosy and Pharmaceutical Sciences

How to cite this article:

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. DOI: 10.33545/27067009.2021.v3.i2a.30

Vol. 3, Issue 2, Part A (2021)

Review on forced degradation studies