A Workflow Approach for the Identification and Structural Elucidation of Impurities of Quetiapine Hemifumarate Drug Substance

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Michael D. Jones, Marian Twohig, Karen Haas, and Robert S. Plumb
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Application Notes
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Application Notes
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In this application note, we demonstrate how data collection using ACQUITY UPLC with the SYNAPT MS provides high chromatographic resolution, ample sensitivity, and superior mass accuracy to identify many of the impurities in the quetiapine hemifumarate drug substance. MSE provides simultaneous acquisition of both high and low collision energy, maximizing the information gathered from a single injection. This analytical workflow was followed by a deliberate data processing workflow that streamlines the fragment analysis and structural elucidation process and provided greater confidence in the end results. This workflow-based approach delivers the rapid and systematic set of comprehensive results that are needed to identify and confirm impurities in an API impurity profile.

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