Organic Chemistry of Drug Degradation

A clear understanding of the organic chemistry of drug degradation is essential for maintaining the stability, efficacy, and safety of a drug product throughout its shelf-life. During analytical method development, stability testing, and pharmaceutical manufacturing troubleshooting activities, one of the frequently occurring and usually challenging events is the identification of drug degradants and the understanding of drug degradation mechanisms and pathways. This book is written by a veteran who has first-hand experience in drug design and development, degradation mechanism studies, analytical development, and manufacturing process troubleshooting and improvement. The author discusses various degradation pathways with an emphasis on the mechanisms of the underlying organic chemistry, which will aid greatly in efforts of degradant identification, formulation and analytical development, and manufacturing process improvement. Organic reactions that are significant in drug degradation are discussed and illustrated with examples. The author brings the book to a close with two chapters on strategy for rapid elucidation of drug degradants and control of drug degradation with regard to the current regulatory requirements and guidelines. One chapter that should be given special attention is the one on Oxidative Degradation. Oxidative degradation is one of the most common degradation pathways but perhaps the most complex of all. This chapter employs more than sixty drug degradation case studies with in-depth discussion on their unique degradation pathways. With increasing regulatory requirements on quality and safety of pharmaceutical products, this book will be an invaluable resource for pharmaceutical and analytical scientists as well as medicinal chemists.