Chiral Separation Methods for Pharmaceutical and Biotechnological Products Book

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