Abstract

FORCED DEGRADATION STUDIES: PRACTICAL APPROACH AND REGULATORY GUIDANCE

Jagruti Dolas*, Shailesh Jawarkar, Madhuri Game, Monika Jadhav, Kalyani Bhongade

ABSTRACT

Forced degradation is a powerful tool used routinely in pharmaceutical development in order to develop the stability indicating method that lead to quality stability data and to understand the degradation of new drug substance and drug product at condition more severe than accelerated condition. In addition, the regulatory guidance is very general and does not explain about the performance of forced degradation study. There is not much regulatory guidance available, which can provide step-by-step detail on stress testing. Therefore, in present review paper we described the extensive overview of forced degradation studied. ICH guideline demonstrates certain degradation condition like light, oxidation, dry heat, acidic, basic, hydrolysis etc. These studies are mainly used for the determination of stability of molecule under accelerated condition.

Keywords: Forced degradation, ICH, Degradation product, Degradation condition.