Lokesh Bhattacharyya i s 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.
Thorough coverage of the applications of ion chromatography to the analysis of pharmaceutical drugs and biologicals Since its introduction in the mid–1970s, ion chromatography (IC), a high–performance liquid chromatography technique, has developed into an important analytical methodology for a number of applications in the pharmaceutical, biotechnology, and environmental industries. With contributors from academia, the pharmaceutical and biotech industries, and instrument manufacturers, this book takes a comprehensive approach to this steadily growing field to present different perspectives, experiences, and expertise influencing the development of IC. This book features: Potential IC applications in different aspects of development, characterization, and quality control testing of pharmaceutical and biological drug products, and vaccines Recent advances in IC technology and applications, case studies, investigations and trouble–shooting experiences, and issues of current regulatory compliance An appendix with critical physical and chromatographic parameters related to IC A close look at technology that has permitted IC to be coupled with mass spectrometry, which is a critical milestone for a wider interest in IC as a product characterization tool A valuable learning tool for beginners and a comprehensive reference for seasoned professionals, Applications of Ion Chromatography for Pharmaceutical and Biological Products brings important new insight to pharmaceutical and biotechnology science.
Contributors. Preface. Part I. Principles, Mechanism, and Instrumentation. 1. Ion Chromatography—Principles and Applications ( Lokesh Bhattacharyya ). 2. Retention Processing in Ion–Exclusion Chromatography: A New Perspective ( Milko Novic and Paul R. Haddad ). 3. Pulsed Electrochemical Detection in Ion Chromatography ( William R. LaCourse ). 4. Suppressor Design and Detection for Ion Chromatography ( Kannan Srinivasan, Sheetal Bhardwaj, Rong Lin and Christopher Pohl ). 5. Modelling and Optimization of ion Chromatographic Separations of Pharmaceutically Relevant Organic Ions ( Philip Zakaria, Greg Dicinoski, Melissa Hanna–Brown and Paul R. Haddad ). Part II. Pharmaceutical Applications. 6. Ion Chromatography in Pharmaceutical Drug Analysis ( Lokesh Bhattacharyya ). 7. Analysis for Impurities by Ion Chromatography ( Shreekant V. Karmarkar ). 8. Ion Chromatography Analysis of Aminoglycoside Antibiotics ( Valoran O. Hanko and Jeffrey S. Rohrer ). 9. Use of Cation–Exchange Ion Chromatography in the Analysis of Pharmaceuticals ( Christopher Crafts, Bruce Bailey, Paul Gamache, Xiaodong Liu, and Ian Acworth ). 10. Comprehensive Approaches for Measurement of Active Pharmaceutical Ingredients, Counter–ions, and Excipients using HPLC with Charged Aerosol Detection ( Christopher Crafts, Bruce Bailey, Paul Gamache, Xiaodong Liu, and Ian Acworth ). 11. High Performance Ion Chromatographic Analysis of Cholinergic Compounds: Carbachol and Bethanechol, and Associated Degradation Products ( David Trowbridge ). 12. Ion Chromatographic Analysis of Pharmaceuticals for Authenticity and Adulteration ( David S. Jackson ). 13. Ion Chromatography of Drug Product Counter–ions and other Ions in Drug Products ( Brian M. De Borba and Jeffrey S. Rohrer ). 14. Sample Preparation Techniques in Ion Chromatography for Pharmaceutical Applications ( Jay Gandhi ). 15. Validation of Ion Chromatographic Methods ( Shreekant V. Karmarkar ). 16. Pharmacopeial Applications of Ion Chromatography ( Ravi Ravichandran ). Part III. Biotechnology Applications. 17. Glycan Analysis by High Performance Anion Exchange Chromatography with Pulsed Amperometric Detection ( Lokesh Bhattacharyya ). 18. Monosaccharide Analysis of Glycoproteins by High–Performance Anion–Exchange ( Jeffrey S. Rohrer ). 19. Two–Dimensional Ion Chromatography for Simultaneous Determination of Carbohydrates and Amino Acids ( Petr Jandik and Jun Cheng ). 20. Monitoring Protein N–glycosylation Consistency using HPAEC–PAD ( Carl Grey ). 21. Oligosaccharide Analysis by High–Performance Anion–Exchange Chromatography Hyphenated to Integrated Pulsed Amperometric Detection and On–Line Ion–Trap Mass Spectrometry ( Cees Bruggink ). Part IV. Vaccine Applications. 22. Applications of Ion Chromatography in Biological Analyses ( Alfred V. Del Grosso and Brandon Duong ). 23. High Performance Anion–Exchange Chromatography with Pulsed Amperometric Detection (HPAEC–PAD) Analysis of GBS Glycoconjugate Vaccines: from Fermentation to Final Product ( Stefano Ricci, Barbara Fabbri, Sara Giannini Silvia Bernardini, and Marcello Morelli ). 24. Stability Studies and Characterization of Meningococcal A, C, Y, and W 135 Glycoconjugate Vaccine ( Valeria Carinci, Alberto Bernardini, Cristiana Campa, Claudia Magagnoli, Francesca Beccai, and Sandro D’Ascenzi ). Part V. Appendices. 1. Dissociation Constants (pKa) of Organic Acids (at 20 oC). 2. Dissociation Constants (pK a ) of Common Sugars and Alcohols. 3. Bibliography on Ion Chromatography and its Application in Pharmaceuticals and Biotechnology. Index.
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