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TRANSCRIPT
Introduction to Modern Liquid
Chromatography
Lloyd R. SnyderJoseph J. Kirkland
John W. Dolan
Third Edition
Edited by
BIRENDRA N. PRAMANIK MIKE S. LEE GUODONG CHEN
PRAMANIK
LEE
CHEN
CHARACTERIZATION OF IMPURITIES AND
DEGRADANTS USING MASS SPECTROMETRY
CH
AR
AC
TERIZATIO
N OF IM
PU
RITIES A
ND D
EGR
AD
AN
TS U
SING M
ASS SPEC
TRO
METR
Y
Keto amide form (protease inhibitor)
Enol form(unknown impurity)
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 pharma-ceutical research and specialists in analytical chemistry can expand on with the insightful procedures presented in this book.
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.
An in-depth examination of the importance
of mass spectrometry in drug discovery
Wiley Series on Pharmaceutical Science and Biotechnology: Practices, Applications and Methods
Mike S. Lee, Series Editor
Edited by MIKE S. LEE
MINGSHE ZHU
Mass Spectrometry in Drug Metabolism
and DispositionBASIC PRINCIPLES AND APPLICATIONS
Comprehensive Chromatography in Combination with Mass SpectrometryEdited by Luigi Mondello
Wiley Series on Mass Spectrometry Dominic M. Desiderio and Nico M. Nibbering, Series Editor
E D I T E D B Y
M I K E S . L E E
MASS SPECTROMETRY HANDBOOK
Wiley Series on Pharmaceutical Science and Biotechnology: Practices, Applications, and Methods
Mike S. Lee, Series Editor
Integrated Strategies for Drug Discovery Using Mass Spectrometry
Mike S. Lee978-0-471-46127-2
$168.00 • 2005
Mass Spectrometry HandbookMike S. Lee
978-0-470-53673-5 $199.95 • 2012
Mass Spectrometry in Drug Metabolism and Disposition:
Basic Principles and Applications Mike S. Lee, Mingshe Zhu
978-0-470-40196-5 $145.00 • 2011
Characterization of Impurities and Degradants Using
Mass Spectrometry Birendra Pramanik, Mike S. Lee,
Guodong Chen978-0-470-38618-7
$110.00 • 2011
Comprehensive Chromatography in Combination with Mass Spectrometry
Luigi Mondello978-0-470-43407-9
$125.00 • 2011
Handbook of Sample Preparation
Janusz Pawliszyn, Heather L. Lord
978-0-470-09934-6$158.00 • 2010
Electrospray and MALDI Mass Spectrometry: Fundamentals,
Instrumentation, Practicalities, and Biological Applications, 2nd Edition
Richard B. Cole978-0-471-74107-7
$158.00 • 2010
Introduction to Modern Liquid Chromatography, 3rd Edition
Lloyd R. Snyder, Joseph J. Kirkland, John W. Dolan
978-0-470-16754-0 $132.00 • 2009
Mass Spectrometry in Drug Metabolism and Pharmacokinetics
Ragu Ramanathan978-0-471-75158-8
$111.00 • 2008
Drug Metabolism in Drug Design and Development
Donglu Zhang, Mingshe Zhu, William G. Humphreys978-0-471-73313-3
$144.00 • 2007
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HANDBOOK of
SAMPLE PREPARATION
Edited byJanusz Pawliszyn • Heather L. Lord
MAURER, HANS H. / PFLEGER, KARL /WEBER, ARMIN A.
The world's most comprehensive referencefor clinical and forensic toxicologists iskeeping pace with recent developments inclinical and forensic toxicology in its newrelease: Another 1000 new spectra havebeen added to this gold standard, includingnovel designer drugs and a broad range ofAIDS and other therapeutics for a total ofover 8,650 clinically relevant substances,including about 5,200 metabolites. To aidin compound identification, all substancesare classified according to their toxicologi-cal categories.
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Mass Spectral Library of Drugs, Poisons, Pesticides,
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Mass Spectral Library of Drugs, Poisons, Pesticides,
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Available DatabaseFormats: ACD; AgilentChemstation; NISTMSSEARCH; FinniganGCQ, SSQ, TSQ, ICIS,ITS40, Magnum; INCOS,Iontrap; PerkinElmerTurbomass; ShimadzuGC/MS; Thermo GalacticSpectralID; Varian Saturn;VG Labbase, Masslab;Waters Masslynx;Xcalibur
Carefully read the End User License Agreement contained onthe CD-ROM or the accompanying package before usingand/or installing this product
32398-2 CD Book Maurer:32398-2 CD Book Maurer 18.07.2011 13:16 Uhr Seite 1
PETER RÖSNER
Mass Spectra ofDesigner Drugs 2012
CD-ROM
Mass Spectra of Designer Drugs 2012
Fred W. McLafferty, NIST978-3-527-33332-5 $10,989.00 • 2011
Mass Spectral Library of Drugs, Poisons, Pesticides, Pollutants
Herbert Oberacher978-3-527-32398-2 $5,000.00 • 2012
DVD-ROM
HERBERT OBERACHER
WILEY REGISTRY®
of Tandem MS DataMSforID
Wiley Registry of Tandem MS Data, MS for ID
Hans H. Maurer, Karl Pfleger, Armin A. Weber
978-1-118-03744-7 $6,895.00 • 2011
FRED W. MCLAFFERTYFRFRFRFFRFRFRFRRRRRRFRFRRRFRFRRRRRRRFRRRRRREDEDEEEEDEDEDEDEDEDEDEDEDEEDDDDDEDDD WWWWWWWWWWWWWWWWW.... MMMMMMMMMMMMMMMMMMCCCCCCCCCCCLALALALALAAAAALALAALALLAAAALAFFFFFFFFFFFFFFFFFFFFFFFFFFFFFFFFFFFFFFEEEEEEEERERERERERERRRRREERREEREEEERERRREEERREEEEEEEREREEERERE TTTTTTYTYTYTYTYTYTYTTYTTYYTYYYTYYYTYYYYYYYY
DVD-ROM
FRED W. MCLAFFERTY
WILEY REGISTRY®
9th Edition / NIST 2011
Mass Spectral Library
Wiley Registry 9th Edition / NIST 2011 Peter Rösner
978-1-11801624-4 $4,350.00 • 2012
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