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Quantitative determination of residual 2-(2-chloroethoxy) ethanol (CEE) in quetiapine fumarate by gas chromatogaraphy
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Advances in Bioscience and Biotechnology·Volume 01 (2010)·Pages 367–371·Published 30 December 2010·DOI10.4236/abb.2010.15049
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Abstract
A simple and specific gas chromatographic method developed and validated for the determination of 2-(2-chloroethoxy) ethanol in Quetiapine Fumarate. The method is carried out with a flame ionization detector and DB-FFAP capillary column. The linearity was established over a range of 40-150 µg ml-1 and correlation coefficient is more than 0.999.
KeywordsGC2-(2-Chloroethoxy) Ethanol
- Richelson, E. (1999) J. Clin. Psychiatry, 60(Suppl 10), 5.
- Caley, C.F. and Rosenbaum, S. (1998) Formulary, 33, 105.
- Proceedings of International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), Tripartite harmonised guideline Q3C Impurities: Residual Solvent’s, 1997.
- The European Agency for the Evaluation of Medicinal Products Evaluation of Medicines for Human Use, ICH Topic Q3C (M) Maintenance of Note for guidance on Impurities: Residual solvents (CPMP/ICH/283/95), Permissible Daily Exposure (PDE) for Tetrahydrofuran and N-Methylpyrrolidone?.
- Proceedings of International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), Tripartite harmonised guideline Q3A (R) Impurities in new drug substances?, 2002.
- Residual solvents (5.4), European Pharmacopoeia, Supplement 4.6., Directorate for the Quality of Medicines of the Council of Europe, Strasbourg, fourth ed., p. 3911, 2004.