TAILIEUCHUNG - APPLICATIONS OF ION CHROMATOGRAPHY FOR PHARMACEUTICAL AND BIOLOGICAL PRODUCTS

Ionic methods of separation have been used since the industrial revolution in Europe to reduce hardness of water. In the mid-nineteenth century, British researchers treated various clays with ammonium sulfate or carbonate in solution to release calcium. In the early twentieth century, zeolite columns were used to remove interfering calcium and magnesium ions from solutions to permit determination of sulfate. Ionic separation procedures were used in the Manhattan project to purify and concentrate radioactive materials needed to make atom bombs. Peterson and Sober [1] reported in 1956 a chromatographic method based on ion exchange to separate proteins | APPLICATIONS OF ION CHROMATOGRAPHY FOR PHARMACEUTICAL AND BIOLOGICAL PRODUCTS PART I PRINCIPLES MECHANISM AND instrumentation 1 ION CHROMATOGRAPHYPRINCIPLES AND APPLICATIONS Lokesh Bhattacharyya Division of Biological Standards and Quality Control Office of Compliance and Biologics Quality Center for Biologics Evaluation and Research Food and Drug Administration Rockville MD INTRODUCTION Ionic methods of separation have been used since the industrial revolution in Europe to reduce hardness of water. In the mid-nineteenth century British researchers treated various clays with ammonium sulfate or carbonate in solution to release calcium. In the early twentieth century zeolite columns were used to remove interfering calcium and magnesium ions from solutions to permit determination of sulfate. Ionic separation procedures were used in the Manhattan project to purify and concentrate radioactive materials needed to make atom bombs. Peterson and Sober 1 reported in 1956 a chromatographic method based on ion exchange to separate proteins. However ion chromatography IC in its modern form was introduced in 1975 by Small et al. 2 . The technique has since gained significant attention for the analysis of a wide variety of analytes in pharmaceutical biotechnology environmental agricultural and other industries. Several books and chapters on IC have provided a detailed review of its principles and instrumentation 3-5 . In 2000 United States Applications of Ion Chromatography for Pharmaceutical and Biological Products First Edition. Edited by Lokesh Bhattacharyya and Jeffrey S. Rohrer. 2012 John Wiley Sons Inc. Published 2012 by John Wiley Sons Inc.

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