Published Paper Details:

Shelf life determination of pharmaceutical products is a critical process in ensuring drug safety, efficacy, and quality over time. It involves evaluating how a drug product degrades under various environmental conditions and estimating the period during which it remains within acceptable specifications. Stability studies, guided by ICH Q1A (R2) guidelines, are essential in this process and form a key part of regulatory submissions. These studies include real-time and accelerated stability testing, retained sample testing, and cyclic temperature stress testing. Factors like pH and temperature significantly influence the rate of degradation, often illustrated using pH-rate profiles. Forced degradation studies, involving hydrolytic, oxidative, photolytic, and thermal stress, help validate the robustness of stability-indicating analytical methods. Techniques such as HPLC-UV, LC-MS/MS, HPTLC, and others are commonly employed for stability analysis. For estimating shelf life, methods including the FDA-recommended approach, direct and inverse methods, simulation techniques, and the Garrett and Carper model are applied. Together, these methodologies provide a scientific foundation for determining the shelf life of pharmaceutical products, supporting drug development, formulation optimization, and patient safety.