It has been a general practice that the analysis of residual solvents in pharmaceuticals is carried out by dissolving the pharmaceutical sample in a suitable solvent and then injecting that solution directly into a GC (gas chromatograph). Headspace gas chromatography has recently come to be widely used for this application. In this method, the sample solution is enclosed in a vial, which is then kept at an appropriate temperature to drive out the highly volatile components into the gas phase in the vial, and then the gas phase is analyzed by gas chromatography. This report refers to our studies of the resolution of the Class 1 and Class 2 solvents to according to the Impurities Guidelines adopted by the ICH (The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), to the Headspace GC adopted in the USP (United States Pharmacopoeia) (467) titled ORGANIC VOLATILE IMPURITIES, and also to our investigation about the relative sensitivities of the Class 1 and Class 2 solvents detected by an FID (flame ionization detector) and an ECD (electron capture detector), and about those dissolved by the different solvents (aqueous solution DMSO (dimethyl suloxide) solution, and DMF (N,N-dimethylformamid) solution).
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