{"product_id":"characterization-of-impurities-and-degradants-using-mass-spectrometry-isbn-9780470386187","title":"Characterization of Impurities and Degradants Using Mass Spectrometry","description":"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. \u003cb\u003ePREFACE.\u003c\/b\u003e \u003cp\u003e\u003cb\u003eCONTRIBUTORS.\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003eACRONYMS.\u003c\/b\u003e \u003c\/p\u003e \u003cp\u003e\u003cb\u003ePART I METHODOLOGY.\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e1 Introduction to Mass Spectrometry\u003c\/b\u003e (\u003ci\u003eScott A. Smith, Ruth Waddell Smith, Yu Xia, and Zheng Ouyang\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e1.1 History.\u003c\/p\u003e \u003cp\u003e1.2 Ionization Methods.\u003c\/p\u003e \u003cp\u003e1.3 Mass Spectrometer Types.\u003c\/p\u003e \u003cp\u003e1.4 Tandem Mass Spectrometry.\u003c\/p\u003e \u003cp\u003e1.5 Separation Techniques Coupled to Mass Spectrometry.\u003c\/p\u003e \u003cp\u003e1.6 Prospects for Mass Spectrometry.\u003c\/p\u003e \u003cp\u003eReferences. \u003c\/p\u003e \u003cp\u003e\u003cb\u003e2 LC Method Development and Strategies\u003c\/b\u003e (\u003ci\u003eGang Xue and Yining Zhao\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e2.1 Introduction.\u003c\/p\u003e \u003cp\u003e2.2 Column, pH and Solvent Screening.\u003c\/p\u003e \u003cp\u003e2.3 Gradient and Temperature Optimization.\u003c\/p\u003e \u003cp\u003e2.4 Orthogonal Screening.\u003c\/p\u003e \u003cp\u003e2.5 High-Efficiency Separation.\u003c\/p\u003e \u003cp\u003e2.6 Conclusions.\u003c\/p\u003e \u003cp\u003eReferences. \u003c\/p\u003e \u003cp\u003e\u003cb\u003e3 Rapid Analysis of Drug-Related Substances using Desorption Electrospray Ionization and Direct Analysis in Real Time Ionization Mass Spectrometry\u003c\/b\u003e (\u003ci\u003eHao Chen and Jiwen Li\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e3.1 Introduction.\u003c\/p\u003e \u003cp\u003e3.2 Ionization Apparatus, Mechanisms and General Performance.\u003c\/p\u003e \u003cp\u003e3.3 Drug Analysis in Biological Matrices using DESI and DART.\u003c\/p\u003e \u003cp\u003e3.4 High-Throughput Analysis.\u003c\/p\u003e \u003cp\u003e3.5 Chemical Imaging and Profiling.\u003c\/p\u003e \u003cp\u003e3.6 Future Perspectives.\u003c\/p\u003e \u003cp\u003eReferences. \u003c\/p\u003e \u003cp\u003e\u003cb\u003e4 Orbitrap High-Resolution Applications\u003c\/b\u003e (\u003ci\u003eRobert J. Strife\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e4.1 Historical Anecdote.\u003c\/p\u003e \u003cp\u003e4.2 General Description of Orbitrap Operating Principles.\u003c\/p\u003e \u003cp\u003e4.3 The Orbitrap is a \"Fourier Transform\" Device.\u003c\/p\u003e \u003cp\u003e4.4 Performing Experiments in Trapping Devices.\u003c\/p\u003e \u003cp\u003e4.5 Determining Elemental Compositions of \"Unknowns\" Using an Orbitrap.\u003c\/p\u003e \u003cp\u003e4.6 Orbitrap Figures of Merit in Mass Measurement.\u003c\/p\u003e \u003cp\u003e4.7 HPLC Orbitrap MS: Accurate Mass Demonstration and Differentiation of Small Molecule Formulas Very Proximate in Mass\/Charge Ratio Space.\u003c\/p\u003e \u003cp\u003e4.8 Determination of Trace Contaminant Compositions by Simple Screening HPLC-MS and Infusion Orbitrap MS.\u003c\/p\u003e \u003cp\u003e4.9 Determining Substructures: Orbitrap Tandem Mass Spectrometry (MSn).\u003c\/p\u003e \u003cp\u003e4.10 Multianalyzer (Hybridized) System: The Linear Ion Trap\/Orbitrap for MS\/MS and Higher-Order MS\u003ci\u003en\u003c\/i\u003e, \u003ci\u003en\u003c\/i\u003e\u0026gt;2.\u003c\/p\u003e \u003cp\u003e4.11 Mass Mapping to Discover Impurities.\u003c\/p\u003e \u003cp\u003e4.12 The Current Practice of Orbitrap Mass Spectrometry.\u003c\/p\u003e \u003cp\u003e4.13 Conclusion.\u003c\/p\u003e \u003cp\u003eReferences. \u003c\/p\u003e \u003cp\u003e\u003cb\u003e5 Structural Characterization of Impurities and Degradation Products in Pharmaceuticals Using High-Resolution LC-MS and Online Hydrogen\/Deuterium Exchange Mass Spectrometry\u003c\/b\u003e (\u003ci\u003eGuodong Chen and Birendra N. Pramanik\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e5.1 Introduction.\u003c\/p\u003e \u003cp\u003e5.2 Characterization of Impurities.\u003c\/p\u003e \u003cp\u003e5.3 Characterization of Degradation Products.\u003c\/p\u003e \u003cp\u003e5.4 Conclusions.\u003c\/p\u003e \u003cp\u003eReferences. \u003c\/p\u003e \u003cp\u003e\u003cb\u003e6 Isotope Patten Recognition on Molecular Formula Determination for Structural Identification of Impurities\u003c\/b\u003e (\u003ci\u003eMing Gu\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e6.1 Introduction.\u003c\/p\u003e \u003cp\u003e6.2 Three Basic Approaches to Isotope Pattern Recognition.\u003c\/p\u003e \u003cp\u003e6.3 The Importance of Lineshape Calibration.\u003c\/p\u003e \u003cp\u003e6.4 Spectral Accuracy.\u003c\/p\u003e \u003cp\u003e6.5 Formula Determination with Quadrupole MS.\u003c\/p\u003e \u003cp\u003e6.6 Formula Determination with High-Resolution MS.\u003c\/p\u003e \u003cp\u003e6.7 Conclusions and Future Directions.\u003c\/p\u003e \u003cp\u003eReferences. \u003c\/p\u003e \u003cp\u003e\u003cb\u003ePART II APPLICATION.\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e7 Practical Application of Very High-Pressure Liquid Chromatography Across the Pharmaceutical Development-Manufacturing Continuum\u003c\/b\u003e (\u003ci\u003eBrent Kleintop and Qinggang Wang\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e7.1 Introduction.\u003c\/p\u003e \u003cp\u003e7.2 Theory and Benefits of VHPLC.\u003c\/p\u003e \u003cp\u003e7.3 VHPLC Method Development.\u003c\/p\u003e \u003cp\u003e7.4 Other Practical Considerations.\u003c\/p\u003e \u003cp\u003e7.5 VHPLC Method Validation.\u003c\/p\u003e \u003cp\u003e7.6 Summary.\u003c\/p\u003e \u003cp\u003eReferences. \u003c\/p\u003e \u003cp\u003e\u003cb\u003e8 Impurity Identification for Drug Substances\u003c\/b\u003e (\u003ci\u003eDavid W. Berberich, Tao Jiang, Joseph McClurg, Frank Moser, and R. Randy Wilhelm\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e8.1 Introduction.\u003c\/p\u003e \u003cp\u003e8.2 Case Studies.\u003c\/p\u003e \u003cp\u003e8.3 Conclusions.\u003c\/p\u003e \u003cp\u003eReferences. \u003c\/p\u003e \u003cp\u003e\u003cb\u003e9 Impurity Identification in Process Chemistry by Mass Spectrometry\u003c\/b\u003e (\u003ci\u003eDavid Q. Liu, Mingjiang Sun, and Lianming Wu\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e9.1 Introduction.\u003c\/p\u003e \u003cp\u003e9.2 Experimentation.\u003c\/p\u003e \u003cp\u003e9.3 Applications.\u003c\/p\u003e \u003cp\u003e9.4 Concluding Remarks.\u003c\/p\u003e \u003cp\u003eAcknowledgments.\u003c\/p\u003e \u003cp\u003eReferences. \u003c\/p\u003e \u003cp\u003e\u003cb\u003e10 Structure Elucidation of Pharmaceutical Impurities and Degradants in Drug Formulation Development\u003c\/b\u003e (\u003ci\u003eChangkang Pan, Frances Liu, and Michael Motto\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e10.1 Importance of Drug Degradation Studies in Drug Development.\u003c\/p\u003e \u003cp\u003e10.2 Drug Degradation Studies in Formulation Development.\u003c\/p\u003e \u003cp\u003e10.3 Complexity of Impurity Identification in Drug Development.\u003c\/p\u003e \u003cp\u003e10.4 Strategy for Structure Elucidation of Unknowns.\u003c\/p\u003e \u003cp\u003e10.5 Hyphenated Analytical Techniques Used in Drug Development.\u003c\/p\u003e \u003cp\u003e10.6 Case Studies.\u003c\/p\u003e \u003cp\u003eAcknowledgment.\u003c\/p\u003e \u003cp\u003eReferences. \u003c\/p\u003e \u003cp\u003e\u003cb\u003e11 Investigation of Degradation Products and Extractables in Developing Topical OTC (Over the Counter) and NCE (New Chemical Entity) Consumer Healthcare Medication Products\u003c\/b\u003e (\u003ci\u003eFa Zhang\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e11.1 Introduction.\u003c\/p\u003e \u003cp\u003e11.2 Oxidatively Induced Coupling of Miconazole Nitrate with Butylated Hydroxytoluene in a Topical Ointment.\u003c\/p\u003e \u003cp\u003e11.3 Extractables from Rubber Closures of a Prefilled Semisolid Drug Applicator.\u003c\/p\u003e \u003cp\u003e11.4 New Degradation Products and Pathways of Vitamin D and Its Analogs.\u003c\/p\u003e \u003cp\u003e11.5 Reductive Degradation of a 1,2,4-Thiadiazolium Derivative.\u003c\/p\u003e \u003cp\u003e11.6 Conclusions.\u003c\/p\u003e \u003cp\u003eReferences. \u003c\/p\u003e \u003cp\u003e\u003cb\u003e12. Characterization of Impurities and Degradants in Protein Therapeutics by Mass Spectrometry\u003c\/b\u003e (\u003ci\u003eLi Tao, Michael Ackerman, Wei Wu, Peiran Liu, and Reb Russell\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e12.1 Introduction to Therapeutic Proteins.\u003c\/p\u003e \u003cp\u003e12.2 Recent Advances in Mass Spectrometry.\u003c\/p\u003e \u003cp\u003e12.3 Impurities.\u003c\/p\u003e \u003cp\u003e12.4 Degradation Products.\u003c\/p\u003e \u003cp\u003e12.5 Conclusions.\u003c\/p\u003e \u003cp\u003eReferences. \u003c\/p\u003e \u003cp\u003e\u003cb\u003e13 Identification and Quantification of Degradants and Impurities in Antibodies\u003c\/b\u003e (\u003ci\u003eDavid M. Hambly and Himanshu S. Gadgil\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e13.1 Introduction to Antibodies and Protein Drugs.\u003c\/p\u003e \u003cp\u003e13.2 Overview of Degradations and Impurities in Protein Drugs and Antibodies.\u003c\/p\u003e \u003cp\u003e13.3 Methods to Identify and Quantitate Degradations and Impurities.\u003c\/p\u003e \u003cp\u003e13.4 Conclusions.\u003c\/p\u003e \u003cp\u003eAppendix.\u003c\/p\u003e \u003cp\u003eReferences.\u003c\/p\u003e \u003cp\u003e\u003cb\u003eINDEX. \u003c\/b\u003e\u003c\/p\u003e  \"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)  \u003cp\u003e \u003c\/p\u003e  \u003cb\u003eBIRENDRA N. PRAMANIK\u003c\/b\u003e 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.  \u003cp\u003e\u003cb\u003eMIKE S. LEE\u003c\/b\u003e 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.\u003c\/p\u003e \u003cp\u003e\u003cb\u003eGUODONG CHEN\u003c\/b\u003e 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.\u003c\/p\u003e  \u003cb\u003eAn in-depth examination of the importance of mass spectrometry in drug discovery\u003c\/b\u003e  \u003cp\u003eIn 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.\u003c\/p\u003e \u003cp\u003e\u003ci\u003eCharacterization of Impurities and Degradants Using Mass Spectrometry\u003c\/i\u003e 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:\u003c\/p\u003e \u003cul\u003e \u003cli\u003e \u003cp\u003eStudies involving characterization of process-related impurities (including potential genotoxic impurities) and excipient-related impurities in formulated products\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003eThe current application and future trends in the structural characterization of impurities and degradants in small molecule pharmaceuticals and biologics\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003eStep-by-step approaches and new strategies for solving challenging problems related to pharmaceutical research\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003eCoverage of trace level analysis and identification of genotoxic impurities\u003c\/p\u003e \u003c\/li\u003e \u003c\/ul\u003e \u003cp\u003eMass 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.\u003c\/p\u003e","brand":"Wiley","offers":[{"title":"Default Title","offer_id":47988902920421,"sku":"NP9780470386187","price":142.95,"currency_code":"USD","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/1842\/7735\/files\/9780470386187.jpg?v=1761781989","url":"https:\/\/k12savings.com\/es\/products\/characterization-of-impurities-and-degradants-using-mass-spectrometry-isbn-9780470386187","provider":"K12savings","version":"1.0","type":"link"}