| Description |
1 online resource (xxii, 462 pages) : illustrations |
| Contents |
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 |
| Summary |
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 strateg |
| Bibliography |
Includes bibliographical references and index |
| Notes |
English |
|
Print version record |
| Subject |
Drugs -- Analysis.
|
|
Drugs -- Spectra.
|
|
Mass spectrometry.
|
|
Contamination (Technology)
|
|
Microbial contamination.
|
|
Drugs -- Microbiology.
|
|
Mass Spectrometry -- methods
|
|
Pharmaceutical Preparations -- analysis
|
|
Drug Contamination
|
|
Mass Spectrometry
|
|
mass spectrometry.
|
|
contamination.
|
|
MEDICAL -- Drug Guides.
|
|
MEDICAL -- Nursing -- Pharmacology.
|
|
MEDICAL -- Pharmacology.
|
|
MEDICAL -- Pharmacy.
|
|
Microbial contamination
|
|
Drugs -- Microbiology
|
|
Contamination (Technology)
|
|
Drugs -- Analysis
|
|
Drugs -- Spectra
|
|
Mass spectrometry
|
| Form |
Electronic book
|
| Author |
Pramanik, Birendra N., 1944-
|
|
Lee, Mike S., 1960-
|
|
Chen, Guodong
|
| ISBN |
9780470921371 |
|
0470921374 |
|
9780470921364 |
|
0470921366 |
|
1283239434 |
|
9781283239431 |
|
9786613239433 |
|
6613239437 |
|
