System suitability and validation for chiral purity assays of drug substances

LCGC North America

Volumn 24, Issue 11, 2006, Pages 1216-1221

  Wrezel, P W ^a   Chion, I ^b   Pakula, R ^b   Weissmueller, D W ^b  

^a REGIS TECHNOLOGIES INC   (United States)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

EID: 33845255568     PISSN: 15275949     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (7)

1. Review of Stereochemistry (Regis Technologies, Inc., Morton Grove, Illinois, 2000).
2. CRC Handbook of Optical Resolutions via Diastereomeric Salt Formation, D. Kozma, Ed. (CRC Press, Boca Raton, Florida, 2001).
3. Chiral Application Guide V (Regis Technologies, Inc., Morton Grove, Illinois, 2005).
4. Technical Support, Products and Services for Chiral Analysis and Separations (Chiral Technologies, Inc., West Chester, Pennsylvania, 2004).
5. A Guide to the Analysis of Chiral Compounds by GC, Restek bulletin 59889 (1997).
6. S. Fanali, An Introduction to Chiral Analysis by Capillary Electrophoresis, Bio-Rad Laboratories bulletin 1973 US/EG REVA (1995).
7. ICH Q2(R1): Validation of Analytical Procedures: Text and Methodology (International Conference on Harmonization of Technical Requirements for the Registration of Drugs for Human Use, Geneva, Switzerland, 2005).