Organic Chemistry of Drug Degradation, 1st Edition written by Min Li
The overwhelming majority of medication are natural molecular entities. A transparent understanding of the organic chemistry of drug degradation is crucial to maintaining the stability, efficacy, and security of a drug product throughout its shelf-life. During analytical methodology development, stability testing, and pharmaceutical manufacturing troubleshooting actions, one of the regularly occurring and normally challenging events can be the identification of drug degradants and understanding of drug degradation mechanisms and pathways. This book is written by a veteran of the pharmaceutical industry who has first-hand experience in drug design and growth, drug degradation mechanism research, analytical growth, and manufacturing course of troubleshooting and improvement.
The author discusses various degradation pathways with an emphasis on the mechanisms of the underlying natural chemistry, which ought to support drastically within the efforts of degradant identification, formulation improvement, analytical improvement, and manufacturing course of improvement. Organic reactions which might be vital in drug degradation will first be reviewed and then illustrated by examples of drug degradation reported within the literature. The author brings the ebook to an in depth with a ultimate chapter devoted to the strategy for speedy elucidation of drug degradants with regard to the present regulatory requirements and guidelines. One chapter that needs to be given special attention is Chapter three, Oxidative Degradation. Oxidative degradation is without doubt one of the commonest degradation pathways however perhaps the most complex one. This chapter employs more than sixty drug degradation case research with in-depth dialogue in regard to their distinctive degradation pathways. With the increasing regulatory requirements on the standard and safety of pharmaceutical merchandise, specifically with regard to drug impurities and degradants, the e-book can be a useful resource for pharmaceutical and analytical scientists who interact in formulation growth, analytical improvement, stability studies, degradant identification, and support of manufacturing process improvement. As well as, it is going to also be helpful to scientists engaged in drug discovery and improvement as well as in drug metabolism studies.
Dr. Min Li is an Affiliate Director at Analytical Chemistry in Improvement and Supply – Provide Analytical Sciences Division of Merck & Co., Inc. He has led technical teams of senior-degree scientists (Senior and Principal Scientists) for varied analytical and pharmaceutical manufacturing course of investigation and troubleshooting, impurity peak identification, study of drug degradation mechanisms, analytical method development, validation, specification setting, and help for brand new drug filing. He graduated from Fudan University and obtained his Ph.D. in Organic Chemistry from Johns Hopkins University, followed by a postdoctoral analysis at University of Illinois at Chicago in medicinal chemistry. Dr. Li was a Principal Scientist at Roche (1995 – 1998), a Scientific Fellow at Merck (1998 – 2005), and a manager at Schering-Plough (2005 – 2010). He was president of Sino-American Pharmaceutical Professionals Affiliation (SAPA) between 2003 and 2004. Dr. Li is the primary/main writer of greater than forty publications in a multi-disciplinary enviornment including natural, medicinal, bioconjugate, and analytical chemistry, in addition to mass spectrometry. He has been invited to current in quite a few worldwide scientific conferences and conferences.