Discover how SIFT-MS technology enables rapid, sensitive, and efficient detection of ethylene oxide in Polysorbate 80.
Sponsored Content by Syft TechnologiesReviewed by Olivia FrostNov 6 2024 Selected ion flow tube mass spectrometry greatly simplifies quantitative ethylene oxide analysis in Polysorbate 80 excipient. It has a time-to-first test result eight times faster than the existing compendial method and a daily sample throughput nine to 14 times higher.
This methodology is laborious from the viewpoints of sample preparation and testing.6 The rate-limiting stage in sample preparation is the six-hour purification of the polyethylene glycol matrix corresponding to the sample . The GC-FID cycle runtime is 38 minutes per sample. Figure 2. Schematic diagram of SIFT-MS – a direct, chemical-ionization analytical technique. Image Credit: Syft Technologies
The numerous reagent ions constantly remove uncertainty from isobaric overlaps in mixtures of multiple analytes. As the nominal sample flow into the SIFT-MS instrument is 420 µL s-1, a make-up gas flow was also introduced through the sampling head. Linear measurement in the gas phase is shown in Figure 4. Acetaldehyde is the main potential interferer for EtO, similar to the compendium GC-FID method, though both require very different analytical approaches.10Table 1. SIFT-MS reaction chemistry , product ion formulae, branching ratio , and mass-to-charge ratio ) for ethylene oxide and acetaldehyde, a potential interferent.
Figure 5 shows how these compounds can be separated simply via this approach. The insignificant signal of acetaldehyde remains so with growing concentrations of EtO ; the reverse is shown with increasing concentrations of acetaldehyde . Figure 3 shows the SIFT-MS results, which indicate that EtO can be perceived above baseline even when just 5 mg of T80 is used .
Such high dilution levels are well-suited to SIFT-MS but not GC-FID because of the former technique’s greater sensitivity. It can be presumed that when conducting tests on EtO in P80 with hSIFT-MS, a sample of only 10 mg needs to be introduced to 1 mL of water, with calibration performed against an external standard prepared in water.
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