Applications of Ion Chromatography for Pharmaceutical and Biological Products

Herausgegeben von Bhattacharyya, Lokesh; Rohrer, Jeffrey S.

• Gebundenes Buch

Produktbeschreibung

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.

Produktdetails

• Verlag: Wiley & Sons
• 1. Auflage
• Seitenzahl: 476
• Erscheinungstermin: 27. März 2012
• Englisch
• Abmessung: 240mm x 161mm x 30mm
• Gewicht: 816g
• ISBN-13: 9780470467091
• ISBN-10: 0470467096
• Artikelnr.: 34437467

Autorenporträt

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.

Inhaltsangabe

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 Novi 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 W135 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 (pKa) of Common Sugars and
Alcohols. 3. Bibliography on Ion Chromatography and its Application in
Pharmaceuticals and Biotechnology. Index.