Applications of Ion Chromatography for Pharmaceutical and Biological Products

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.

Contributors ix Preface xi Part I Principles, Mechanism, and Instrumentation 1 1 Ion Chromatography—principles and Applications 3 Lokesh Bhattacharyya 2 Retention Processes in Ion-exclusion Chromatography: a New Perspective 23 Milko Novič and Paul R. Haddad 3 Pulsed Electrochemical Detection in Ion Chromatography 49 William R. LaCourse 4 Suppressor Design and Detection for Ion Chromatography 91 Kannan Srinivasan, Sheetal Bhardwaj, Rong Lin, and Christopher Pohl 5 Modelling and Optimization of Ion Chromatographic Separations of Pharmaceutically RelevantOrganic Ions 107 Philip Zakaria, Greg Dicinoski, Melissa Hanna-Brown, and Paul R. Haddad Part II Pharmaceutical Applications 135 6 Ion Chromatography in Pharmaceutical Drug Analysis 137 Lokesh Bhattacharyya 7 Analysis for Impurities by Ion Chromatography 159 Shreekant V. Karmarkar 8 Ion Chromatography Analysis of Aminoglycoside Antibiotics 175 Valoran P. Hanko and Jeffrey S. Rohrer 9 Use of Cation-exchange Ion Chromatography in the Analysis of Pharmaceuticals 193 Christopher Pohl, Maria Rey, and Rosanne Slingsby 10 Comprehensive Approaches for Measurement of Active Pharmaceutical Ingredients, Counter-ions,and Excipients Using HPLC with Charged Aerosol Detection 221 Christopher Crafts, Bruce Bailey, Paul Gamache, Xiaodong Liu, and Ian Acworth 11 High Performance Ion Chromatographic Analysis of Cholinergic Compounds: Carbachol andBethanechol, and Associated Degradation Products 237 David Trowbridge 12 Ion Chromatographic Analysis of Pharmaceuticals for Authenticity and Adulteration 247 David S. Jackson 13 Ion Chromatography of Drug Product Counter-ions and other Ions in Drug Products 259 Brian M. De Borba and Jeffrey S. Rohrer 14 Sample Preparation Techniques in Ion Chromatography for Pharmaceutical Applications 271 Jay Gandhi 15 Validation of Ion Chromatographic Methods 285 Shreekant V. Karmarkar 16 Pharmacopeial Applications of Ion Chromatography 309 Ravi Ravichandran Part III Biotechnology Applications 321 17 Glycan Analysis by High Performance Anion Exchange Chromatography with Pulsed AmperometricDetection 323 Lokesh Bhattacharyya 18 Monosaccharide Analysis of Glycoproteins By High-performance Anion-exchange Chromatographywith Pulsed Amperometric Detection 339 Jeffrey S. Rohrer 19 Two-dimensional Ion Chromatography for Simultaneous Determination of Amino Acids andCarbohydrates 351 Petr Jandik and Jun Cheng 20 Monitoring Protein N-glycosylation Consistency Using Hpaec-pad 365 Carl Grey 21 Oligosaccharide Analysis by High-performance Anion-exchange Chromatography Hyphenated toIntegrated Pulsed Amperometric Detection and On-line Ion-trap Mass Spectrometry 379 Cees Bruggink Part IV Vaccine Applications 393 22 Applications of Ion Chromatography in Biological Product Analyses 395 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 423 Stefano Ricci, Barbara Fabbri, Sara Giannini, Silvia Bernardini, Marcello Morelli, and Sandro D’Ascenzi 24 Stability Studies and Characterization of Meningococcal A, C, Y, and W 135 Glycoconjugate Vaccine435 Valeria Carinci, Alberto Bernardini, Cristiana Campa, Claudia Magagnoli, Francesca Beccai, and Sandro D’Ascenzi Part V Appendices 449 Appendix 1 DISSOCIATION CONSTANTS (pKa) OF ORGANIC Acids (at 20◦C) 451 Appendix 2 DISSOCIATION CONSTANTS (pKa) OF COMMON Sugars and Alcohols 455 Index 457