Stability studies are essential for evaluating the long-term chemical, physical, and microbiological integrity of a pharmaceutical API. These studies expose the API to various environmental factors like temperature, humidity, and light to assess its shelf life and potential degradation pathways.
The findings are pivotal for establishing optimal storage conditions, setting expiration dates, and providing handling guidelines. These studies not only supply critical data for regulatory approval but also guarantee that the API maintains its quality, efficacy, and safety throughout its designated shelf life.