Detection of Leachables in Topical Ointments and Gels

Topical ointments, creams, and gels are essential for delivering medication through the skin, but their safety depends on ensuring that harmful chemicals do not migrate from packaging into the product. The U.S. FDA requires rigorous leachables studies for these formulations; however, their oil-in-water emulsion structures create highly complex matrices that are difficult to analyze using traditional methods.

In this study, researchers evaluated two novel sample preparation methods for extracting chemicals commonly found in metal tubes and tins. By utilizing the Pegasus BTX GC-TOFMS, the team successfully identified target leachables even when they co-eluted with heavy matrix interferences.

The workflow leveraged automated mass spectral deconvolution to uncover hidden peaks, while ChromaTOF Sync software allowed for rapid comparison between unspiked and blind-spiked extracts. This non-targeted approach provides a powerful solution for ensuring drug product safety by detecting trace-level contaminants that might otherwise be missed.