Consumer safety can be negatively impacted by chemical compounds migrating from products. Regulations are in place for industries in which the exposure routes are of higher risk, such as pharmaceuticals, medical devices, foodstuffs and cosmetics. Testing for these contaminants is commonly known as an Extractables & Leachables study.
To ensure regulatory compliance, avoid product recalls, and protect their brands, organizations must carefully control and monitor their products to eliminate the potential risks associated with extractables and leachables. Partnering with Waters means you can make critical decisions – in less time and with greater confidence by leveraging powerful technologies that are specifically designed to improve your workflow, increase testing throughput, and support compliance reporting. Our continually updated E&L library contains useful information on product ions, retention time, and collision cross section values to increase your confidence in the identification of unknowns.
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Perform confident identification of E&L components in complex matrices with the Xevo G3 QTof. MSE, a data independent acquisition, ensures accurate identifications when screening against a library and provides additional information to aid structural elucidation.
Achieve high confidence in identification of unknowns in complex mixtures using cyclic ion mobility with high-resolution mass spectrometry (HRMS). Unparalleled separation by shape and m/z with measurement of the Collisional Cross Section (CCS).
Increase your compound coverage to include identification of unknown volatiles with Waters Atmospheric Pressure Gas Chromatography (APGC), interfacing GC to existing Waters HRMS.
A complete extractables analysis workflow can be undertaken using the Waters UNIFI Application within the waters_connect Software Platform. The workflow can be customized to meet user requirements and streamline the analysis of complex datasets. Shown in the figure is the component summary table for each analyte in the Waters E&L SST mix, the extracted ion chromatogram for Irganox 245, and a summary plot of retention times for this analyte across all injections.
APGC provides softer ionization resulting in molecular ion detection. Combined with MSE, a data independent acquisition mode, the simultaneous acquisition of the accurate mass information of both precursor and fragment ions is enabled. This information is key for confident screening of extractables and for the structural elucidation of unknowns to ultimately aid full compounds coverage.
The Waters UNIFI Application elucidation toolkit can be used for the tentative identification of unknown peaks using the accurate mass and fragmentation data. Results include the predicted elemental composition, i-FIT confidence (isotopic pattern algorithm used to score each formula), common name for the compound, number of fragment matches, and the number of citations. Synonyms, structure, and high energy spectrum for this compound are also displayed.
The Waters UNIFI Application within the waters_connect Software Platform can be used for quantitation for an extractables and leachables analysis. Calibration curves can be included in an analysis to calculate the concentration of compounds present in unknown samples.
