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Chiral Separation Methods for Pharmaceutical and Biotechnological Products. Edition No. 1

  • Book

  • November 2010
  • John Wiley and Sons Ltd
  • ID: 1551376
Discusses chiral separations and offers guidance for selecting the optimum method for desired results

Chiral separations represent the most intriguing and, by some measures, most difficultseparations of chemical compounds. This book provides researchers and students an under-standing 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.

Table of Contents

Contributors.

Preface.

1 Overview of Chiral Separations (Satinder Ahuja).

2 Regulatory & Development Considerations of Chiral Compounds (Robert L. Zeid).

3 Basic Considerations in Method Development for Chiral Compounds (Satinder Ahuja).

4 Separations of Chiral Compounds on Polysaccharide Columns (Clinton W. Amoss and Norbert M. Maier).

5 Chiral Separations by Various Techniques (Jian G. Ning).

6 Chiral Discrimination Study for Polysaccharide Based Chiral Stationary Phase (Yun K. Ye).

7 Comparison of Chiral Chromatographic Columns for Pharmaceuticals (Gregory K. Webster).

8 Chiral Separation Screens for Pharmaceutical Analysis and Purification in an Industrial Laboratory Environment (Robert DePianta, Kenneth Douville, Beverly Nickerson, and Ricardo E. Borjas).

9 The Separation of Enantiomers by Gas Chromatography on Chiral Stationary Phases (Volker Schurig).

10 Separations of Chiral Compounds by SFC (Ziqiang Wang).

11 Chiral Separations by Capillary Electrophoresis (Debby Mangelings and Yvan Vander Heyden).

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

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, and Peter Sajonz).

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

15 Chirality of Biomolecules and Biotechnology Products (Satinder Ahuja).

Index.

Authors

Satinder Ahuja