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?.

has been cited by the following article:

• TITLE: Quantitative determination of residual 2-(2-chloroethoxy) ethanol (CEE) in quetiapine fumarate by gas chromatogaraphy

  AUTHORS: Pravish Tiwari, Ravi Yadav, Padmakar A. Sathe, Deepali Gangrade

  KEYWORDS: GC; 2-(2-Chloroethoxy) Ethanol

  JOURNAL NAME: Advances in Bioscience and Biotechnology, Vol.1 No.5, December 30, 2010

  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.