Syft Tracer Pharm11

Direct, real-time mass spectrometry offers regulated pharmaceutical and CDMO testing laboratories the opportunity to significantly reduce their time to analytical results due to minimal sample preparation, rapid sample analysis, and the inherent flexibility of column-free techniques. Comprised of the next-gen SIFT-MS Syft Tracer platform, integrated CTC autosampler, high-throughput inlet, and the SyftAuditTracer software package, the Syft Tracer Pharm11 is an analytical solution designed specifically for the pharmaceutical industry. Syft Technologies examines how the Syft Tracer Pharm11 is compliant with 21 CFR Part 11 by demonstrating an analytical workflow in which key regulatory compliance features are highlighted.

Nitrosamines have been classified as belonging to the Cohort of Concern (CoC) in the International Council for Harmonisation (ICH) M7 with stringent AI limits, and drug manufacturers frequently perform impurity testing to meet such regulatory guidelines. Selected ion flow tube mass spectrometry (SIFT-MS) provides rapid, sensitive, and selective quantitation of nitrosamines in pharmaceutical drug products. This application note describes an alternative approach to quantifying nitrosamines using SIFT-MS: static headspace analysis (SHA) of dissolved drug products. See how headspace-SIFT-MS analysis achieves excellent linearity and limits of detection (<10% of the acceptable daily intake (AI) limits) for six nitrosamines.

In this application note, Syft introduces the Syft Tracer™, the latest innovation in selected ion flow tube mass spectrometry (SIFT-MS) technology. This next-generation instrument has been designed to revolutionize workflows by quantifying formaldehyde directly from the polymer headspace without the need for dissolution or derivatization steps. The Syft Tracer ensures stable quantitation of formaldehyde for almost a month, significantly reducing calibration frequency and enabling a sample throughput of over 220 samples/day. Moreover, it reports the first result four times faster than chromatography-based analyses, making it a highly efficient and time-saving solution for analytical processes.

Enhancement of workflows for conventional analysis of volatile impurities is a great challenge due to chromatographic separation's relatively long analysis time. Additionally, expert operators are required, there is considerable sample preparation time, switching from one method to another requires a configuration change (hence re-calibration) or separate dedicated instruments and system maintenance is high. Syft Technologies provides information on how its mass spectrometry instruments can increase productivity and describes scenarios applicable to contract research organization (CRO) and contract drug manufacturing organization (CDMO) laboratories in which multiple volatiles methods need to be conducted regularly, while also catering for the occasional urgent and unscheduled analytical procedure.

Watch this webinar introducing the Syft Tracer Pharm11, the world's only 21 CFR Part 11 compliant real-time, direct mass spectrometer, and discussing SIFT-MS for CDMO workflows.