This episode covers the essential methods used to assess drug stability and predict shelf life, ensuring long-term product quality. It explains the concept of stability-indicating methods and their crucial role in distinguishing between the active drug and its degradation products. The discussion delves into the importance of validated analytical methods for ensuring accuracy and reliability in stability testing. Real-world examples and case studies illustrate the application of these principles in drug development.

Beyond simply checking if a drug is still potent, stability testing involves a comprehensive evaluation of its chemical and physical characteristics over time. The episode highlights the need for internationally agreed-upon guidelines, such as the ICH guidelines, for conducting stability studies. Furthermore, it explores the impact of various environmental factors on drug stability, including temperature, humidity, and light exposure. The discussion also covers the testing protocols and regulatory requirements for both drug substances and drug products, emphasizing the importance of testing containers and closures. Finally, the episode touches on the retesting of expired drug substances and the impact of manufacturing changes on shelf life.