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Accelerating residual solvents analysis in 21 CFR Part 11 compliant settings

Introduction
 

SIFT-MS is a direct, real-time mass spectrometry (MS) technique which offers revolutionary volatile compound analysis capabilities to Pharma and CDMO labs due to its fast time to data, time efficient workflows, analytical flexibility, and ease of use. It expedites analytical workflows, such as residual solvents analysis, by generating faster results than traditional methods. Syft Tracer Pharm11 is a SIFT-MS-based solution that includes SyftAuditTracer software designed for 21 CFR Part 11 compliant environments. Volatile impurities can be characterized in real- time including nitrosamines, ethylene oxide, and residual solvents.

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