Characterization of extractable and leachable components in packaging, food contact materials, medical devices and many other consumables used in various industries is becoming more and more important due to ever increasing global regulations.
Typically, identification of compounds using UPLC-Ion Mobility-Mass Spectrometry analysis is based on retention time, accurate mass, fragmentation ion information and CCS values. For the analysis of extractable and leachable components during the whole analysis confidence that both the detected mass and the CCS values obtained are accurate, is critical in order to ensure correct compounds identification is achieved.
In this work we demonstrate using UPLC-Vion IMS QTof and the UNIFI Scientific Information System, where after initial 'push button' instrument set-up, analysis is carried out using bracketed system suitability standards. The method specific system suitability standard used contains 18 compounds, representative of common industry polymer additives and preservatives, which cover a wide mass range, and contain compounds which ionize in both -ve and +ve MS modes. The system suitability standards were analysis at the start, during and at the end of the analysis, and the criteria for acceptance was set at mass accuracy <=3% and CCS values <=2%. A method specific UNIFI workflow was established, which incorporated review of system suitability standards.