Journal of Pharmaceutical Chemistry and Drug formulation ISSN: 3108-0782 (Online)

Authors: Priya Singh, Dr. Ramesh Kumar

Abstract: Stability studies are critical for evaluating the physical, chemical, and microbiological integrity of pharmaceutical formulations during storage and handling. Predicting shelf-life ensures product safety, efficacy, and regulatory compliance. This paper discusses systematic approaches for conducting stability studies, including accelerated, long-term, and stress testing, in accordance with ICH guidelines. Factors such as temperature, humidity, light exposure, and packaging materials are analyzed to assess their impact on formulation stability. Analytical techniques including HPLC, UV-Visible spectroscopy, and dissolution testing are utilized to monitor degradation. The study also explores mathematical modeling and kinetic analysis for shelf-life prediction. A representative table summarizes the stability parameters of selected formulations under different storage conditions. Results demonstrate that robust stability evaluation and predictive modeling are essential for ensuring product quality throughout its intended shelf-life. The paper highlights the importance of stability studies in drug development, regulatory submissions, and lifecycle management.

Keywords: Stability studies, shelf-life prediction, pharmaceutical formulations, accelerated compliance, ICH guidelines