Characterization of Impurities and Degradants Using Mass Spectrometry

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.