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Poster Presentations
Day 3, June 24（Tue.）
Room P (Maesato East, Foyer, Ocean Wing)
- 3P-PM-38
The next frontier in extractable screening analyses: Increased identification confidence provided by a benchtop multi-reflecting time-of-flight mass spectrometer
(Waters Corp)
oJayne Kirk, Rachel Sanig, Lee Gethings
Screening for potential extractables in pharmaceutical packaging and medical devices is crucial due to safety concerns. Compounds above the analytical evaluation threshold must be identified and reported for toxicological assessment. High confidence in these identifications is challenging due to sample complexity, false positives, and numerous possible compound identifications per chromatographic peak.
This study reports an extractables analysis using a benchtop multi-reflecting time-of-flight mass spectrometer (Xevo MRT MS) with high mass accuracy and resolution. A compound mix with typical extractables was injected into a liquid chromatography (LC) instrument connected to the mass spectrometer. Data were acquired using a data-independent acquisition (DIA) method, MSE. Pharmaceutical packaging and a procedural blank were extracted in isopropanol (IPA) and spiked with the mix to investigate results in a complex matrix.
Mass accuracy at sub 1 ppm and mass resolution over 60K from 200 to 1200 m/z was achieved, significantly narrowing possible compounds and increasing identification confidence. High energy fragmentation data with comparable sub 1 ppm mass accuracies to low energy data were critical for structural elucidation. The Xevo MRT MS maintained high mass resolution across acquisition rates, ensuring confident identification in complex matrices.