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Cover image for Applications of ion chromatography for pharmaceutical and biological products
Title:
Applications of ion chromatography for pharmaceutical and biological products
Publication Information:
Hoboken, N.J. : John Wiley & Sons, c2012.
Physical Description:
xii, 463 p. : ill. ; 24 cm.
ISBN:
9780470467091

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30000010325242 QD79.C453 A67 2012 Open Access Book Book
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Summary

Summary

This is a comprehensive source of information on the application of ion chromatography (IC) in the analysis of pharmaceutical drugs and biologicals. This book, with contributors from academia, pharma, the biotech industry, and instrument manufacturing, presents the different perspectives, experience, and expertise of the thought leaders of IC in a comprehensive manner. It explores potential IC applications in different aspects of product development and quality control testing. In addition, an appendix section gives information on critical physical and chromatographic parameters related to IC and information on current manufacturers of IC systems, columns, and other components.


Author Notes

Lokesh Bhattacharyya is a Lab Chief at the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA). Prior to beginning his FDA work in 2006, he had over fourteen years of industry experience as an analytical chemist and biochemist. Dr. Bhattacharyya has thirty-nine papers, nine review articles, and nearly thirty conferences as speaker or session chair to his credit.
Jeffrey S. Rohrer is the Director of Applications Development for Thermo Fisher Scientific, Dionex Products. In this position he directs the work of three corporate applications laboratories in California, China, and Thailand. These labs develop HPLC, IC, HPAE-PAD, and other LC-based assays. Dr. Rohrer is an author of over fifty peer-reviewed publications. He is also a member of the United States Pharmacopeia Expert Committee on Monograph Development for Antibiotics, Antivirals, and Antimicrobials.


Table of Contents

Lokesh BhattacharyyaMilko Novic and Paul R. HaddadWilliam R. LaCourseKannan Srinivasan and Sheetal Bhardwaj and Rong Lin and Christopher PohlPhilip Zakaria and Greg Dicinoski and Melissa Hanna-Brown and Paul R. HaddadLokesh BhattacharyyaShreekant V. KarmarkarValoran P. Hanko and Jeffrey S. RohrerChristopher Pohl and Maria Rey and Rosanne SlingsbyChristopher Crafts and Bruce Bailey and Paul Gamache and Xiaodong Liu and Ian AcworthDavid TrowbridgeDavid S. JacksonBrian M. De Borba and Jeffrey S. RohrerJay GandhiShreekant V. KarmarkarRavi RavichandranLokesh BhattacharyyaJeffrey S. RohrerPetr Jandik and Jun ChengCarl GreyCees BrugginkAifred V. Del Grosso and Brandon DuongStefano Ricci and Barbara Fabbri and Sara Giannini and Silvia Bemardini and Marcello Morelli and Sandro D'AscenziValeria Carinci and Alberto Bernardini and Cristiana Campa and Claudia Magagnoli and Francesca Beccai and Sandro D'Ascenzi
Contributorsp. ix
Prefacep. xi
Part I Principles, Mechanism, And Instrumentationp. 1
1 Ion Chromatography-Principles And Applicationscp. 3
2 Retention Processes in Ion-Exclusion Chromatography: A New Perspectivep. 23
3 Pulsed Electrochemical Detection in ion Chromatographyp. 49
4 Suppressor Design And Detection For ion Chromatographyp. 91
5 Modelling And Optimization of ion Chromatographic Separations of Pharmaceutically Relevant Organilcionsp. 107
Part II Pharmaceutical Applicationsp. 135
6 Ion Chromatography in Pharmaceutical Drug Analysisp. 137
7 Analysis For Impurities By Ion Chromatographyp. 159
8 Ion Chromatography Analysis of Aminoglycoside Antibloticsp. 175
9 Use of Cation-Exchange ion Chromatography in The Analysis of Pharmaceuticalsp. 193
10 Comprehensive Approaches For Measurement of Active Pharmaceutical Ingredients, Counter-Ions, And Excipients Using HPLC With Charged Aerosol Detectionp. 221
11 High Performance ion Chromatographic Analysis of Cholinerglc Compounds: Carbachol And Bethanechol, And Associated Degradation Productsp. 237
12 Ion Chromatographic Analysis of Pharmaceuticals For Authenticity And Adulterationp. 247
13 Ion Chromatography of Drugproduct Counter-Ions And Other Ions in Drug Productsp. 259
14 Sample Preparation Techniques in Ion Chromatography For Pharmaceutical Applicationsp. 271
15 Validation of Ion Chromatographic Methodsp. 285
16 Pharmacopeial Applications of Ion Chromatographyp. 309
Part III Biotechnology Applicationsp. 321
17 Glycan Analysis By High Performance Anion Exchange Chromatography With Pulsed Amperometric Detectionp. 323
18 Monosaccharide Analysis of Glycproteins By High-Performance Anion-Exchange Chromatography With Pulsed Amperometric Detectionp. 339
19 Two-Dimensional ion Chromatography For Simultaneous Determination of Amino Acids and Carbohydratesp. 351
20 Monitoring Protein N-Glycosylation Consistency Using HPAEC-PADp. 365
21 Oligosaccharide Analysis By High-Performance Anion-Exchange Chromatography Hyphenated To Integrated Pulsed Amperometric Detection And on-Line Ion-Trap Mass Spectrometryp. 379
Part iv Vaccine Applicationsp. 393
22 Applications of ion Chromatography in Biologlcal product Analysesp. 395
23 High Performance Anion-Exchange Chromatography With Pulsed Amperometric Detection (HPAEC-PAD) Analysis of GBS Glycoconjugate Vaccines: From Fermentation to Final Productp. 423
24 Stability Studies And Characterization of Meningococcal A, C, Y, And W 135 Glycoconjugate Vaccinep. 435
Part V Appendicesp. 449
Appendix 1 Dissociation constants (pK a ) of organic Acids (AT 20°C)p. 451
Appendix 2 Dissociation constants (pK a ) of common Sugars and Alcoholsp. 455
Indexp. 457
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