Interinstrumental Transfer of a Chiral Capillary Electrophoretic Method: The Use of Robustness Test Information to Overcome Differences in Detector and Data-Handling Specifications

Author:

De Cock Bart,Mangelings Debby,Vander Heyden Yvan

Publisher

Springer Science and Business Media LLC

Subject

Organic Chemistry,Clinical Biochemistry,Biochemistry,Analytical Chemistry

Reference34 articles.

1. Ahuja S (1991) In: Ahuja S (ed) Chiral separations by liquid chromatography. American Chemical Society, Washington DC, pp 1–8

2. Mangelings D, Vander Heyden Y (2011) Chiral separation methods for pharmaceutical and biotechnology products. In: Ahuja S (ed) lxChiral separation methods for pharmaceutical and biotechnological products, chapter 11. Wiley, New York, pp 331–350

3. Fillet M, Bechet I, Chiap P, Hubert Ph, Crommen J (1995) J Chromatogr A 717:203–209

4. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm122883.htm . Accessed 10 Aug 2017

5. Directive 75/318/EEC: investigation of chiral active substances, http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002816.pdf . Accessed 23 Aug 2017

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