Applications of Ion Chromatography for Pharmaceutical and Biological Products (eBook)

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.

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.

"This book is a model of what can be achieved with a
well-developed plan and the support of expert authors."
(Chromatographia, 2012)