Fast generic chiral separation strategies using electrophoretic and liquid chromatographic techniques

Author:

Ates Hasret,Mangelings Debby,Vander Heyden Yvan

Publisher

Elsevier BV

Subject

Clinical Biochemistry,Spectroscopy,Drug Discovery,Pharmaceutical Science,Analytical Chemistry

Reference23 articles.

1. FDA's policy statement for the development of new stereo isomeric drugs, 5/1/1992 http://www.fda.gov./cder/guidance/stereo.htm.

2. Note for guidance on impurities testing: impurities in new drug substances, EMEA, London, 21 February 2002.

3. ICH Harmonised Tripartite Guideline, Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances (http://www.ich.org/LOB/media/MEDIA430.pdf).

4. Enantioselective chromatography as a powerful alternative for the preparation of drug enantiomers

5. Pharmaceutical development and specification of stereoisomers

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