LEADER 06451oam 22009373 450 001 9910132377503321 005 20240129220212.0 010 $a1-283-23943-4 010 $a9786613239433 010 $a0-470-92136-6 010 $a0-470-92137-4 035 $a(CKB)3520000000000044 035 $a(EBL)693190 035 $a(OCoLC)746326254 035 $a(SSID)ssj0000543243 035 $a(PQKBManifestationID)11324885 035 $a(PQKBTitleCode)TC0000543243 035 $a(PQKBWorkID)10533582 035 $a(PQKB)10911112 035 $a(MiAaPQ)EBC693190 035 $a(EXLCZ)993520000000000044 100 $a20131014h20112011 uy 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 10$aCharacterization of impurities and degradants using mass spectrometry /$fedited by Birendra N. Pramanik, Mike S. Lee, Guodong Chen 210 1$aHoboken :$cWiley,$d2011. 210 4$dİ2011 215 $a1 online resource (xxii, 462 pages) $cillustrations 225 1 $aWiley Series on Pharmaceutical Science and Biotechnology: Practices, Applications and Methods ;$vv.8 300 $aDescription based upon print version of record. 311 0 $a0-470-38618-5 327 $aCHARACTERIZATION OF IMPURITIES AND DEGRADANTS USING MASS SPECTROMETRY; CONTENTS; PREFACE; CONTRIBUTORS; ACRONYMS; PART I: METHODOLOGY; 1. Introduction to Mass Spectrometry; 1.1. History; 1.1.1. Atomic Physics; 1.1.2. Early Applications; 1.1.3. Organic Structural Analysis; 1.1.4. The Biological Mass Spectrometry Revolution; 1.2. Ionization Methods; 1.3. Mass Spectrometer Types; 1.3.1. Magnetic Sector Mass Spectrometers; 1.3.2. Quadrupole Mass Filter and Quadrupole Ion Trap Mass Spectrometers; 1.3.3. Time-of-Flight Mass Spectrometers 327 $a1.3.4. Fourier Transform Ion Cyclotron Resonance Mass Spectrometers; 1.3.5. Orbitrap Mass Spectrometers; 1.4. Tandem Mass Spectrometry; 1.4.1. Ion Isolation; 1.4.2. Ion-Molecule Collisions and Collision-Induced Dissociation; 1.4.3. Electron Capture Dissociation and Electron Transfer Dissociation; 1.5. Separation Techniques Coupled to Mass Spectrometry; 1.5.1. Gas Chromatography-Mass Spectrometry; 1.5.2. Liquid Chromatography-Mass Spectrometry; 1.5.3. Capillary Electrophoresis-Mass Spectrometry; 1.5.4. Ion Mobility Spectrometry-Mass Spectrometry; 1.6. Prospects for Mass Spectrometry; References 327 $a2. LC Method Development and Strategies; 2.1. Introduction; 2.2. Column, pH, and Solvent Screening; 2.2.1. Resolution: Goal of Separation; 2.2.2. Screening: Systematic Approach to Seeking Selectivity; 2.2.3. Screening Instrumentation and Controlling Software; 2.3. Gradient and Temperature Optimization; 2.4. Orthogonal Screening; 2.4.1. Method Orthogonality; 2.4.2. Selection of Orthogonal Methods; 2.4.3. Impurity Orthogonal Screening; 2.5. High-Efficiency Separation; 2.6. Conclusions; References 327 $a3. Rapid Analysis of Drug-Related Substances using Desorption Electrospray Ionization and Direct Analysis in Real Time Ionization Mass Spectrometry; 3.1. Introduction; 3.2. Ionization Apparatus, Mechanisms, and General Performance; 3.2.1. Desorption Electrospray Ionization (DESI); 3.2.2. Direct Analysis in Real Time (DART); 3.3. Drug Analysis in Biological Matrices using DESI and DART; 3.3.1. DESI Application; 3.3.2. DART Application; 3.4. High-Throughput Analysis; 3.5. Chemical Imaging and Profiling; 3.6. Future Perspectives; References; 4. Orbitrap High-Resolution Applications 327 $a4.1. Historical Anecdote; 4.2. General Description of Orbitrap Operating Principles; 4.3. The Orbitrap is a "Fourier Transform" Device; 4.4. Performing Experiments in Trapping Devices; 4.4.1. "Raw" HPLC Data Look Like Infusion Data; 4.4.2. How Much Mass Resolution Should Be Used During HPLC; 4.5. Determining Elemental Compositions of "Unknowns" Using an Orbitrap; 4.6. Orbitrap Figures of Merit in Mass Measurement; 4.6.1. Accuracy; 4.6.2. Precision; 4.6.3. Discussion; 4.7. HPLC Orbitrap MS: Accurate Mass Demonstration and Differentiation of Small Molecule Formulas Very Proximate in Mass/Charge Ratio Space 330 $aThe book highlights the current practices and future trends in structural characterization of impurities and degradants. It begins with an overview of mass spectrometry techniques as related to the analysis of impurities and degradants, followed by studies involving characterization of process related impurities (including potential genotoxic impurities), and excipient related impurities in formulated products. Both general practitioners in pharmaceutical research and specialists in analytical chemistry field will benefit from this book that will detail step-by-step approaches and new strateg 410 0$aWiley Series on Pharmaceutical Science and Biotechnology: Practices, Applications and Methods 606 $aDrugs$xAnalysis 606 $aDrugs$xSpectra 606 $aMass spectrometry 606 $aContamination (Technology) 606 $aPublic Health 606 $aChemistry Techniques, Analytical 606 $aInvestigative Techniques 606 $aEnvironment and Public Health 606 $aHealth Care 606 $aPharmaceutical Preparations 606 $aMass Spectrometry 606 $aDrug Contamination 606 $aHealth & Biological Sciences$2HILCC 606 $aPharmacy, Therapeutics, & Pharmacology$2HILCC 615 0$aDrugs$xAnalysis. 615 0$aDrugs$xSpectra. 615 0$aMass spectrometry. 615 0$aContamination (Technology) 615 2$aPublic Health 615 2$aChemistry Techniques, Analytical 615 2$aInvestigative Techniques 615 2$aEnvironment and Public Health 615 2$aHealth Care 615 2$aPharmaceutical Preparations 615 2$aMass Spectrometry 615 2$aDrug Contamination 615 7$aHealth & Biological Sciences 615 7$aPharmacy, Therapeutics, & Pharmacology 676 $a615.1 676 $a615/.1 701 $aPramanik$b Birendra N.$f1944-$0944851 701 $aLee$b Mike S.$f1960-$0895753 701 $aChen$b Guodong$01000636 801 0$bAU-PeEL 801 1$bAU-PeEL 801 2$bAU-PeEL 906 $aBOOK 912 $a9910132377503321 996 $aCharacterization of impurities and degradants using mass spectrometry$93874222 997 $aUNINA