83 – Analytical Methods in Process Development (S6E8)

This episode explores the vital role of analytical methods in supporting process development and ensuring the consistency of pharmaceutical manufacturing. The conversation centers on key techniques like HPLC, spectroscopy (NMR, UV-Vis), and how these tools are used to monitor reactions in real-time, troubleshoot problems, and optimize process parameters.We'll discuss how analytical data provides critical insights into reaction kinetics, impurity formation, and the impact of scale-up on product quality. Real-world examples from OPR&D will illustrate how these methods are applied to guide process development and ensure that every batch of medication meets the required specifications.