Applications of Ion Chromatography for Pharmaceutical and Biological Products

Thorough coverage of the applications of ion chromatography tothe analysis of pharmaceutical drugs and biologicals

Since its introduction in the mid–1970s, ion chromatography(IC), a high–performance liquid chromatography technique, hasdeveloped into an important analytical methodology for a number ofapplications in the pharmaceutical, biotechnology, andenvironmental industries.

With contributors from academia, the pharmaceutical and biotechindustries, and instrument manufacturers, this book takes acomprehensive approach to this steadily growing field to presentdifferent perspectives, experiences, and expertise influencing thedevelopment of IC.

This book features:

Potential IC applications in different aspects of development,characterization, and quality control testing of pharmaceutical andbiological drug products, and vaccines

Recent advances in IC technology and applications, case studies,investigations and trouble–shooting experiences, and issues ofcurrent regulatory compliance

An appendix with critical physical and chromatographicparameters related to IC

A close look at technology that has permitted IC to be coupledwith mass spectrometry, which is a critical milestone for a widerinterest in IC as a product characterization tool

A valuable learning tool for beginners and a comprehensivereference for seasoned professionals, Applications of IonChromatography for Pharmaceutical and Biological Products bringsimportant new insight to pharmaceutical and biotechnologyscience.

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 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 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.

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.

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