Applications of Ion Chromatography for Pharmaceutical and Biological Products

1. Auflage 2012
ISBN: 978-0-470-46709-1
Verlag: Wiley

Buch, Englisch, 480 Seiten, Format (B × H): 161 mm x 240 mm, Gewicht: 877 g

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.

Autoren/Hrsg.

Bhattacharyya, Lokesh

Rohrer, Jeffrey S

Fachgebiete

• Technische Wissenschaften Verfahrenstechnik | Chemieingenieurwesen | Biotechnologie Biotechnologie Medizinische Biotechnologie
• Naturwissenschaften Chemie Chemie Allgemein Pharmazeutische Chemie, Medizinische Chemie
• Naturwissenschaften Chemie Analytische Chemie Instrumentelle Analytik, Chromatographie
• Technische Wissenschaften Verfahrenstechnik | Chemieingenieurwesen | Biotechnologie Pharmazeutische Technologie

Inhaltsverzeichnis

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 Novic 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

Über Autor(innen)

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.