Identification of the Impurities of Simvastatin Using Exact Mass UPLC/MS

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Robert Plumb, Paul Rainville, Jose Castro-Perez, and Michael Jones (Waters)
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Application Notes
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Application Notes
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Q-Tof Premier

Impurity profiling and identification is an essential part of the drug development and formulation process. The sensitivity and flexibility of exact mass time-of-flight mass spectrometry with alternating collision cell energies, combined with the high resolving power of the ACQUITY UPLC system, allows for the rapid profiling and identification of impurities. The combination of the increased resolution and throughput of ACQUITY UPLC, with the ability of the Q-Tof Premier to collect precursor and product ion data in one analytical run, removes the need for multiple long analytical runs to acquire the required data to identify potential impurities. The data analysis and visualization tools within MassLynx software simplify the data analysis process. These factors combine to dramatically reduce the time to profile samples and identify impurities. Reducing the time required to characterize samples then allows for faster drug development, raw material acceptance, or product release.

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