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Residual solvents in pharmaceuticals are defined as
organic volatile chemicals that are consumed or produced in the manufacture of drug products. It is known that these residual solvents are not completely removed by practical manufacturing techniques. The United States Pharmacopeia (USP) <467> specifies the gas chromatographic (GC) conditions for the analysis of these organic volatile impurities. Static headspace analysis coupled with gas chromatography mass spectrometry (GC/MS) is the ideal technique for the analysis, because target and unknown compounds can be analysed simultaneously with complete confidence in the identification and quantification of the results. The new Bruker automated static headspace auto sampler, the SHS-40, is combined with the SCION SQ mass spectrometer for the analysis of Class I residual solvents in pharmaceutical and dietary supplement products.
Non-target compounds are also determined by automated library search.
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