Abstract

ADVANCEMENTS AND INSIGHTS IN FORCED DEGRADATION STUDIES OF PHARMACEUTICALS: A COMPREHENSIVE REVIEW

Vaibhav S. Adhao, Shreyash Pramod Chaudhari* and Jaya P. Ambhore

ABSTRACT

Forced degradation studies play a crucial role in the development of analytical methods for drug substances and products. These studies involve subjecting substances to various stress conditions to simulate potential degradation during stability studies. This paper outlines the key parameters of forced degradation studies, including stress conditions, degradation levels, analytical techniques, mass balance, optimization of degradation conditions, specificity, and selectivity. The objective is to ensure the stability of drugs, understand their chemical makeup, create stable formulations, and generate samples for detecting degradation products under various conditions. Regulatory guidelines, particularly from the International Council for Harmonisation (ICH), and recommendations for performing forced degradation studies at different stages of drug development are discussed. Factors affecting degradation, such as moisture, excipients, temperature, pH, oxygen, and light, are also explored. The article emphasizes the importance of stability-indicating methods and the relationship between forced degradation studies and stability data.

Keywords: Forced degradation studies, Stress conditions, analytical techniques, International Council for Harmonisation (ICH), Analytical instruments, Validation.