Applications of Ion Chromatography for Pharmaceutical and Biological Products

Informationen zum Autor 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. Klappentext Thorough coverage of the applications of ion chromatography to the analysis of pharmaceutical drugs and biologicalsSince 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 toolA 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. Zusammenfassung This is a comprehensive source of information on the application of ion chromatography (IC) in the analysis of pharmaceutical drugs and biologicals. 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 Novi 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, Ma...

Autorentext

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.

Klappentext
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.

Zusammenfassung
This is a comprehensive source of information on the application of ion chromatography (IC) in the analysis of pharmaceutical drugs and biologicals.

Inhalt

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 Novi 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 Ph…