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Stability Testing

Meaning

Stability Testing is a critical, mandated pharmaceutical and compounding laboratory practice that involves subjecting a final drug product or a specific preparation to various controlled environmental conditions, specifically including temperature extremes, humidity variations, and light exposure, over a precisely defined period of time. The core purpose is to accurately determine how the quality attributes of the active substance or finished product change with time under the influence of these external factors. This rigorous testing establishes the definitive shelf life, the recommended storage conditions, and the accurate expiration date of the final preparation, which is essential for ensuring patient safety and therapeutic efficacy.