A Brief Study on Forced Degradation Studies with Regulatory Guidance

Authors : Yohan Talari; M Sunitha Reddy

Volume/Issue : Volume 8 - 2023, Issue 10 - October

Google Scholar : https://tinyurl.com/2fjuka25

Scribd : https://tinyurl.com/4nnj32sw

DOI : https://doi.org/10.5281/zenodo.10021615

Forced degradation studies is a stability indicating analytical method to identify the pathway of degradation of both drug molecule and product by applying various stress testing conditions than accelerated conditions. As stress degradation study is made compulsory by various countries food and drug agencies for regulatory and market approval of both “Branded drugs and Generic drugs” and products respectively. After introduction of ICH guidelines in 1993, worldwide attention gained by stress degradation evaluation report. Hence we provide a brief overview on the force degradation procedure, method development for characterization and isolation of degraded products and validation of development method.

Keywords : Regulatory Guidelines, Forced Degradation, Method Development, Method Validation, Limits of Impurities.


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31 - December - 2023

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