Method development for impurity profiling in SFC: The selection of a dissimilar set of stationary phases

Author:

Galea Charlene,Mangelings Debby,Heyden Yvan Vander

Publisher

Elsevier BV

Subject

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

Reference29 articles.

1. The European Agency for the Evaluation of Medicinal Products – Evaluation of Medicines for Human Use, ICH Topic Q3A (R) – Impurities Testing Guideline: Impurities in New Drug Substances;EMA,2006

2. An overview of the recent trends in development of HPLC methods for determination of impurities in drugs;Nageswara Rao;J. Pharm. Biomed. Anal.,2003

3. Exploratory chemometric analysis of the classification of pharmaceutical substances based on chromatographic data;Detroyer;J. Chromatogr. A,2000

4. Determining orthogonal chromatographic systems prior to the development of methods to characterise impurities in drug substances;Van Gyseghem;J. Chromatogr. A,2003

5. Selection of reversed-phase liquid chromatographic columns with diverse selectivity towards the potential separation of impurities in drugs;Van Gyseghem;J. Chromatogr. A,2004

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