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Residual Solvent Testing in Drugs

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Technique Used:  Static Headspace coupled with GC/MS Analysis

A pharmaceutical manufacturer wanted to know whether a solvent (ethanol) used in their process was present in a powdered drug. For the residual solvent testing, static headspace and GC/MS analysis were used to identify and quantify the amount of any ethanol present. The resultant gas chromatogram of the drug (top figure) shows a possible solvent peak at a retention time of approximately 1.67 min. The peak is positively identified as ethanol from its mass spectrum (bottom figure). The amount of ethanol was quantified using a one-point standard.

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Gas chromatogram test results for residual solvent testing

Gas chromatogram test results for residual solvent testing