126 - Stability Testing & Forced Degradation (S9E6)

Learn how forced degradation studies guide stability indicating method development and inform formulation design. Examine the purpose behind "torturing" the ingredients and subjecting them to all sorts of conditions. Hear how stresses from temperature and light actually impact a drug and lead to water. Walk through the ways these changes come about, and their impact, such as a product becoming hydrolyzed when exposed to water.The exploration then examines real world applications, such as controlling temperature during crystalization, to create more stable versions. Gain insight into a number of real world scenarios such as how processes avoid biocatalytic oxidations. Examine the importance of adding anti-oxidants in a process as a means for improving the process, as well as examining the methods to create stable final product with as little breakdown as possible. Review how all the data that comes out of this improves the final products and has a massive positive impact on the quality of drugs that consumers need.