Applications of Ion Chromatography for Pharmaceutical and Biological Products

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.

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.