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A major concern for the pharmaceutical industry is to confirm and ensure that final products do not contain impurities that come from the manufacturing process. One source of such impurities is from solvents used during the production of pharmaceuticals that have not been removed prior to packaging.
Gas chromatography is typically used to test for these compounds due to their volatility and the powerful separating capability of the capillary column. A chief concern of the analyst using this instrumentation is how to convert the sample into a suitable form for introduction into the GC.
A convenient analysis of residual solvents is by GC/MS (DSQ with TRACE TR-V1 GC Column) with a headspace injection. This consists of dissolution of the drug in a suitable solvent, followed by introduction of the vapor above the resulting solution into the GC inlet. This is a fast and easy way of separating the volatile solvents from the nonvolatile matrix, which could interfere with the compounds of interest.
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