Solvents often play a critical role in the drug manufacturing process—from cleaning equipment to being a critical component of the actual makeup of a product. But as pharmaceutical manufacturers know, if a solvent isn’t fully or properly removed, residual solvent material can compromise the quality and safety of a drug product.
The good news is that residual solvent testing and analysis can be a helpful prevention tool, as well as a troubleshooting tool, if you suspect residual solvent contamination. Not long ago, we were able to help a client with the latter. Keep reading to learn how.
A pharmaceutical manufacturer wanted to know whether ethanol, a solvent that was used during the manufacturing process, was present in the finished powdered drug product.
Given the problem and the results our client was looking for, our team of scientists went to work using static headspace coupled with gas chromatography mass spectrometry (GC/MS) analysis. Headspace GC/MS analysis is an analytical technique that uses heat to extract volatile or semi-volatile compounds, and then separate, identify, and quantify those compounds.
After running our analysis, the resultant gas chromatogram of the drug (top figure) showed a possible residual solvent peak at a retention time of approximately 1.67 minutes. The peak was positively identified as ethanol from its mass spectrum (bottom figure), and the amount of ethanol was quantified using a one-point standard.
With this information in hand, our client was able to make changes to the manufacturing process to mitigate the issue and bolster the integrity of the powdered drug.
Need of Residual Solvent Testing & Analysis?
Let the Innovatech Labs team help. With more than 100 years of combined experience in the analytical testing field, our team of scientists have the knowledge, expertise, and tools to deliver quality service and accurate, fast results.