Static headspace gas chromatographic method for quantitative determination of residual solvents in pharmaceutical drug substances according to european pharmacopoeia requirements.

@article{Otero2004StaticHG,
  title={Static headspace gas chromatographic method for quantitative determination of residual solvents in pharmaceutical drug substances according to european pharmacopoeia requirements.},
  author={Raquel Rial Otero and G. Carrera and Joan Francesc Dulsat and Jos{\'e} Lu{\'i}s F{\'a}bregas and Juan Claramunt},
  journal={Journal of chromatography. A},
  year={2004},
  volume={1057 1-2},
  pages={
          193-201
        }
}
A static headspace (HS) gas chromatographic method for quantitative determination of residual solvents in a drug substance has been developed according to European Pharmacopoeia general procedure. A water-dimethylformamide mixture is proposed as sample solvent to obtain good sensitivity and recovery. The standard addition technique with internal standard quantitation was used for ethanol, tetrahydrofuran and toluene determination. Validation was performed within the requirements of ICH… CONTINUE READING

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