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Organic Chemistry of Drug Degradation (Hardcover)
Loot Price: R4,624
Discovery Miles 46 240
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Organic Chemistry of Drug Degradation (Hardcover)
Series: Drug Discovery, Volume 29
Expected to ship within 9 - 15 working days
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The vast majority of drugs are organic molecular entities. A clear
understanding of the organic chemistry of drug degradation is
essential to 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 would 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
development, drug 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 should aid greatly in the efforts of degradant
identification, formulation development, analytical development,
and manufacturing process improvement. Organic reactions that are
significant in drug degradation will first be reviewed and then
illustrated by examples of drug degradation reported in the
literature. The author brings the book to a close with a final
chapter dedicated to the strategy for rapid elucidation of drug
degradants with regard to the current regulatory requirements and
guidelines. One chapter that should be given special attention is
Chapter 3, Oxidative Degradation. Oxidative degradation is one of
the most common degradation pathways but perhaps the most complex
one. This chapter employs more than sixty drug degradation case
studies with in-depth discussion in regard to their unique
degradation pathways. With the increasing regulatory requirements
on the quality and safety of pharmaceutical products, in particular
with regard to drug impurities and degradants, the book will be an
invaluable resource for pharmaceutical and analytical scientists
who engage in formulation development, analytical development,
stability studies, degradant identification, and support of
manufacturing process improvement. In addition, it will also be
helpful to scientists engaged in drug discovery and development as
well as in drug metabolism studies.
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