Bhattacharyya / Rohrer Applications of Ion Chromatography in the Analysis of Pharmaceutical and Biological Products

1. Auflage 2012
ISBN: 978-1-118-14699-6
Verlag: John Wiley & Sons
Format: EPUB
Kopierschutz: Adobe DRM (»Systemvoraussetzungen)

E-Book, Englisch, 448 Seiten, E-Book

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.

Inhaltsverzeichnis

Contributors.
Preface.
Part I. Principles, Mechanism, and Instrumentation.
1. Ion Chromatography--Principles and Applications(Lokesh Bhattacharyya).
2. Retention Processing in Ion-Exclusion Chromatography: A NewPerspective (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 ChristopherPohl).
5. Modelling and Optimization of ion Chromatographic Separationsof Pharmaceutically Relevant Organic Ions (Philip Zakaria, GregDicinoski, Melissa Hanna-Brown and Paul R. Haddad).
Part II. Pharmaceutical Applications.
6. Ion Chromatography in Pharmaceutical Drug Analysis (LokeshBhattacharyya).
7. Analysis for Impurities by Ion Chromatography (ShreekantV. 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 ofPharmaceuticals (Christopher Crafts, Bruce Bailey, Paul Gamache,Xiaodong Liu, and Ian Acworth).
10. Comprehensive Approaches for Measurement of ActivePharmaceutical Ingredients, Counter-ions, and Excipients using HPLCwith Charged Aerosol Detection (Christopher Crafts, BruceBailey, Paul Gamache, Xiaodong Liu, and Ian Acworth).
11. High Performance Ion Chromatographic Analysis of CholinergicCompounds: Carbachol and Bethanechol, and Associated DegradationProducts (David Trowbridge).
12. Ion Chromatographic Analysis of Pharmaceuticals forAuthenticity and Adulteration (David S. Jackson).
13. Ion Chromatography of Drug Product Counter-ions and otherIons in Drug Products (Brian M. De Borba and Jeffrey S.Rohrer).
14. Sample Preparation Techniques in Ion Chromatography forPharmaceutical Applications (Jay Gandhi).
15. Validation of Ion Chromatographic Methods (Shreekant V.Karmarkar).
16. Pharmacopeial Applications of Ion Chromatography (RaviRavichandran).
Part III. Biotechnology Applications.
17. Glycan Analysis by High Performance Anion ExchangeChromatography with Pulsed Amperometric Detection (LokeshBhattacharyya).
18. Monosaccharide Analysis of Glycoproteins by High-PerformanceAnion-Exchange (Jeffrey S. Rohrer).
19. Two-Dimensional Ion Chromatography for SimultaneousDetermination of Carbohydrates and Amino Acids (Petr Jandik andJun Cheng).
20. Monitoring Protein N-glycosylation Consistency usingHPAEC-PAD (Carl Grey).
21. Oligosaccharide Analysis by High-Performance Anion-ExchangeChromatography Hyphenated to Integrated Pulsed AmperometricDetection and On-Line Ion-Trap Mass Spectrometry (CeesBruggink).
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 PulsedAmperometric Detection (HPAEC-PAD) Analysis of GBS GlycoconjugateVaccines: from Fermentation to Final Product (Stefano Ricci,Barbara Fabbri, Sara Giannini Silvia Bernardini, and MarcelloMorelli).
24. Stability Studies and Characterization of Meningococcal A,C, Y, and W135 Glycoconjugate Vaccine (ValeriaCarinci, 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 andAlcohols.
3. Bibliography on Ion Chromatography and its Application inPharmaceuticals and Biotechnology.
Index.

Über Autor(innen)

Lokesh Bhattacharyya is a Lab Chief at the Center forBiologics Evaluation and Research (CBER) at the U.S.Food and Drug Administration (FDA). Prior to beginning his FDA workin 2006, he had over fourteen years of industry experience as ananalytical chemist and biochemist. Dr. Bhattacharyya hasthirty-nine papers, nine review articles, and nearly thirtyconferences as speaker or session chair to his credit.
Jeffrey S. Rohrer is the Director of ApplicationsDevelopment for Thermo Fisher Scientific, Dionex Products. In thisposition he directs the work of three corporate applicationslaboratories in California, China, and Thailand. These labs developHPLC, IC, HPAE-PAD, and other LC-based assays. Dr. Rohrer is anauthor of over fifty peer-reviewed publications. He is also amember of the United States Pharmacopeia Expert Committee onMonograph Development for Antibiotics, Antivirals, andAntimicrobials.