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The Analytical Scientist / App Notes / 2023 / Accelerating residual solvents analysis in 21 CFR Part 11 compliant settings

Accelerating residual solvents analysis in 21 CFR Part 11 compliant settings

11/29/2023

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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.

The real-time mass spectrometry advantage


Syft Tracer Pharm11 provides unmatched ease of use while increasing workflow efficiency through minimal sample preparation requirements, high-throughput capacity, and analytical flexibility. System or column changeover between analytical methods is not required, saving both analyst and instrument time. SIFT-MS eliminates the need for chromatographic separation and achieves selectivity via rapidly switchable reagent ions. Analytes undergo different reactions with each reagent ion, generating product ions via independent ion chemistries that are diagnostic of species identity.

>> Download the Application Note as a PDF

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