82 – Impurity Profiling & Control Strategies (S6E7)

This episode focuses on the crucial aspect of identifying and controlling impurities during pharmaceutical manufacturing. The conversation explores the various analytical techniques used to detect and quantify even trace amounts of unwanted substances in drug products. We'll delve into methods like HPLC, NMR, mass spectrometry, and ICP-MS, highlighting their strengths and limitations.The discussion will also cover the strategies manufacturers employ to minimize impurity formation during the manufacturing process. This includes process optimization, careful selection of starting materials and reagents, and the use of scavengers or other purification techniques. Real-world examples from the literature demonstrate how these strategies are applied to meet stringent safety standards.