Chiral Separation Methods for Pharmaceutical and Biotechnological Products / Edition 1

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Overview

Chiral separations represent the most intriguing and, by some measures, most difficult separations of chemical compounds. This book provides researchers and students an understanding of chiral separations and offers a convenient route to selecting the best separation method, saving considerable time and cost in product development.

Considering chiral separations in the biotechnological and pharmaceutical industries, as well as for food applications, Dr. Ahuja provides insights into a broad range of topics. Opening with a broad overview of chiral separations, regulatory considerations in drug product development, and basic issues in method development, the book:

Covers a variety of modern methods such as gas chromatography, high performance liquid chromatography, supercritical fluid chromatography, and capillary electrophoresis

Deals with the impact of chirality on the biological activity of small and large molecules

Provides detailed information on useful chiral stationary phases (CSPs) for HPLC

Includes handy information on selection of an appropriate CSP, including mechanistic studies

Offers strategies for fast method development with HPLC, SFC, and CE

Discusses preparatory methods utilized in the pharmaceutical industry

With in-depth discussions of the current state of the field as well as suggestions to assist future developments, Chiral Separation Methods for Pharmaceutical and Biotechnological Products is an essential text for laboratory investigators, managers, and regulators who are involved in chiral separations in the pharmaceutical industry, as well as students preparing for careers in these fields.

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Editorial Reviews

From the Publisher

“All chapters are thorough and well written by leading experts in the particular fields. The book provides researchers and students in the field of pharmaceutical sciences with a thorough understanding of chiral separations and offers a convenient route to selecting best chiral separation method.” (Anal Bioanal Chem, 2011)

"This is an essential text for analytical and separations scientists in the biotechnological, pharmaceutical, agricultural, and food industries, as well as students." (Laboratory Journal, 22 November 2010)

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Product Details

  • ISBN-13: 9780470406915
  • Publisher: Wiley, John & Sons, Incorporated
  • Publication date: 11/30/2010
  • Edition number: 1
  • Pages: 495
  • Product dimensions: 6.40 (w) x 9.40 (h) x 1.30 (d)

Meet the Author

SATINDER (SUT) AHUJA is a recognized expert in the field of chromatography and separations who has published numerous papers and more than a dozen books, including three on chiral separations. As president of Ahuja Consulting, he has advised major pharmaceutical companies in the United States, Europe, and India. He has also taught short courses for ACS and AAPS on chiral separations by chromatography. Recently, Dr. Ahuja chaired a symposium on Chiral Separations at the American Chemical Society meeting in Boston.
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Table of Contents

Contributors vii

Preface ix

1 Overview of Chiral Separations Satinder Ahuja 1

2 Regulatory and Development Considerations of Chiral Compounds Robert L. Zeid 9

3 Basic Considerations in HPLC Method Development of Chiral Compounds Satinder Ahuja 35

4 Separation of Chiral Compounds on Polysaccharide Columns Clinton W. Amoss Norbert M. Maier 57

5 Chiral Separations by Various Techniques Jian G. Ning 131

6 Chiral Discrimination Study for Polysaccharide-Based Chiral Stationary Phases Yun K. Ye 147

7 Comparison of Chiral Chromatography Columns for Pharmaceutical Method Development Gregory K. Webster 193

8 Chiral Screening Methods for Pharmaceutical Analysis and Purification in an Industrial Laboratory Robert DePianta Kenneth Douville Beverly Nickerson Ricardo E. Borjas 209

9 Separation of Enantiomers by Gas Chromatography on Chiral Stationary Phases Volker Schurig 251

10 Separations of Chiral Compounds by SFC Ziqiang Wang 299

11 Chiral Separations by Capillary Electrophoresis Debby Mangelings Yvan Vander Heyden 331

12 High-Throughput Screening and Method Development Strategies to Separate Chiral Drug Compounds in HPLC, SFC, and CE Hasret Ates Debby Mangelings Yvan Vander Heyden 383

13 Use of Enantioselective Synthesis and Preparative Chiral Chromatography to Access a Challenging Enantiopure Pharmaceutical Candidate from a Mixture of Four Stereoisomers Christopher J. Welch Derek H. Henderson William R. Leonard Mirlinda Biba Mike Zacuto Fred Fleitz Amude Kassim Cheng-yi Chen Peter Sajonz 417

14 A Look into the Future: Chiral Analysis Using Chemical Sensor Technology Gregory K. Webster William J. Buttner 429

15 Chirality of Biomolecules and Biotechnology Products Satinder Ahuja 441

Index 469

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