Characterization of impurities and degradants using mass spectrometry / edited by Birendra N. Pramanik, Mike S. Lee, Guodong Chen.

Frontmatter -- Methodology. Introduction to Mass Spectrometry / Scott A Smith, Ruth Waddell Smith, Yu Xia, Zheng Ouyang -- LC Method Development and Strategies / Gang Xue, Yining Zhao -- Rapid Analysis of Drug-Related Substances Using Desorption Electrospray Ionization and Direct Analysis in Real Time Ionization Mass Spectrometry / Hao Chen, Jiwen Li -- Orbitrap High-Resolution Applications / Robert J Strife -- Structural Characterization of Impurities and Degradation Products in Pharmaceuticals Using High-Resolution LC-MS and Online Hydrogen/Deuterium Exchange Mass Spectrometry / Guodong Chen, Birendra N Pramanik -- Isotope Patten Recognition on Molecular Formula Determination for Structural Identification of Impurities / Ming Gu -- Application. Practical Application of Very High-Pressure Liquid Chromatography across the Pharmaceutical Development₆Manufacturing Continuum / Brent Kleintop, Qinggang Wang -- Impurity Identification for Drug Substances / David W Berberich, Tao Jiang, Joseph McClurg, Frank Moser, R Randy Wilhelm -- Impurity Identification in Process Chemistry by Mass Spectrometry / David Q Liu, Mingjiang Sun, Lianming Wu -- Structure Elucidation of Pharmaceutical Impurities and Degradants in Drug Formulation Development / Changkang Pan, Frances Liu, Michael Motto -- Investigation of Degradation Products and Extractables in Developing Topical OTC (Over the Counter) and NCE (New Chemical Entity) Consumer Healthcare Medication Products / Fa Zhang -- Characterization of Impurities and Degradants in Protein Therapeutics by Mass Spectrometry / Li Tao, Michael Ackerman, Wei Wu, Peiran Liu, Reb Russell -- Identification and Quantification of Degradants and Impurities in Antibodies / David M Hambly, Himanshu S Gadgil -- Index.

Includes bibliographical references and index.

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