GREENER PATHWAYS IN FORCED DEGRADATION STUDIES: ADVANCES IN ECO-FRIENDLY PHARMACEUTICAL STRESS TESTING

Dr. V. S. Saravanan, Dr. M. Jambulingam, K. Shrihari, S. Muthu, H. M. Bhuvanesh, M. Prajen, Karthiraja A. S.*

ABSTRACT

Forced degradation studies are essential in pharmaceutical development for evaluating drug stability, identifying degradation products, and supporting regulatory filings. Traditional stress testing often employs harsh chemicals and solvents that pose environmental and safety concerns. In response, the pharmaceutical industry is adopting green chemistry principles to develop eco-friendly forced degradation protocols. This review comprehensively examines advances in greener reagents, sustainable analytical techniques, green metrics for method evaluation, and regulatory perspectives. Case studies demonstrating successful implementation of environmentally sustainable forced degradation studies are also discussed. The article offers guidance for integrating green chemistry approaches into stability-indicating method development to enhance safety, minimize waste, and comply with evolving regulatory expectations.

Keywords: Forced degradation, Stress testing, Green chemistry, Ecofriendly reagents.