Characterization of Impurities and Degradants Using Mass Spectrometry - by Guodong Chen Hardcover

Book Synopsis

The book highlights the current practices and future trends in structural characterization of impurities and degradants. It begins with an overview of mass spectrometry techniques as related to the analysis of impurities and degradants, followed by studies involving characterization of process related impurities (including potential genotoxic impurities), and excipient related impurities in formulated products. Both general practitioners in pharmaceutical research and specialists in analytical chemistry field will benefit from this book that will detail step-by-step approaches and new strategies to solve challenging problems related to pharmaceutical research.

From the Back Cover

An in-depth examination of the importance of mass spectrometry in drug discovery

In spite of the progress made in research and development to combat diseases such as rheumatoid arthritis, HIV/AIDS, Parkinson's disease, Alzheimer's disease, diabetes, and high blood pressure, the drug discovery process itself is delayed by labor-intensive, time-consuming methods that come with a significant price tag. The result: only one out of thousands of potential compounds investigated ever becomes a commercial drug.

Characterization of Impurities and Degradants Using Mass Spectrometry examines how mass spectrometry (MS) can be applied to improve the drug development process and get drugs approved more quickly. This book looks at spectrometry with an overview of its capabilities, and then guides the reader on techniques as they relate to the analysis of impurities and degradants, showing why these practices hold great significance in advancing the production of pharmaceuticals. In addition, this book includes:

• Studies involving characterization of process-related impurities (including potential genotoxic impurities) and excipient-related impurities in formulated products

• The current application and future trends in the structural characterization of impurities and degradants in small molecule pharmaceuticals and biologics

• Step-by-step approaches and new strategies for solving challenging problems related to pharmaceutical research

• Coverage of trace level analysis and identification of genotoxic impurities

Mass spectrometry has become the leading choice in the structural characterization of pharmaceuticals, providing advanced analysis that both general practitioners in pharmaceutical research and specialists in analytical chemistry can expand on with the insightful procedures presented in this book.

Review Quotes

"It will be valuable for scientists working in industrial, academic, and healthcare-related fields who use mass spectrometry to investigate impurities and degradants." (Doody's, 16 September 2011)

About the Author

BIRENDRA N. PRAMANIK is a Distinguished Fellow at Merck Research Laboratories, where he directs spectroscopy programs covering mass spectrometry and NMR efforts. He was previously a distinguished fellow at Schering-Plough Research Institute. He received his PhD in organic chemistry under the late Professor Ajay K. Bose from Stevens Institute of Technology in 1977.

MIKE S. LEE is President of Milestone Development Services, a provider of consulting services specializing in pharmaceutical analysis and accelerated drug discovery and development strategies in Newtown, Pennsylvania. He previously directed program research at Bristol-Myers Squibb, Pharmaceutical Research Institute in New Brunswick, New Jersey.

GUODONG CHEN is Principal Scientist in Bioanalytical and Discovery Analytical Sciences at Bristol-Myers Squibb in Princeton, New Jersey. He heads a mass spectrometry group in support of drug discovery as well as development programs in small molecule pharmaceuticals and biologics. He received his PhD in analytical chemistry from Purdue University under the direction of Professor R. Graham Cooks.