Abstract

AN UPDATED REVIEW: FORCED DEGRADATION STUDY

Ritesh Kumar Srivastava* and S. Senthil Kumar

ABSTRACT

Forced degradation is a powerful tool used routinely in pharmaceutical development in order to develop the stability indicating methods that lead to quality stability data and to understand the degradation pathways of the drug substances and drug products. The study ensures the appropriate stability of final pharmaceutical products in very early stages of pharmaceutical development. The forced degradation study is an essential step in the design of a regulatory compliant stability program for drug and formalized as a regulatory requirement. Thus, this review discusses the current trends in performance of forced degradation studies by providing a strategy for conducting studies on degradation mechanisms and also describes the analytical methods helpful for the development of stability indicating method.

Keywords: Forced degradation, ICH, QBD, Validation, Peak purity, Mass Balance.