Selected ion flow tube mass spectrometry (SIFT-MS) accelerates ethylene oxide and acetaldehyde analysis in Polysorbate 80 excipients though elimination of very slow sample preparation and shorter run times. Building on the previous study of Silva et al. (2022), this study evaluates the postulated headspace-SIFT-MS approach for Polysorbate 80 products from multiple suppliers and evaluates ethylene oxide and acetaldehyde recoveries. Results confirm that the headspace-SIFT-MS procedure reliably quantifies these analytes without requiring purification of Polysorbate 80 for matrix-matching the calibration standard. Hence, headspace-SIFT-MS analysis of ethylene oxide and acetaldehyde can revolutionize existing workflows.
Conventional ethylene oxide (EtO) analysis in Polysorbate 80 products using gas chromatography with flame ionization detection (GC-FID; United States Pharmacopeia (USP) (2013,2015)) has slow time to result and slow throughput. As described in an earlier application note (Silva et al. (2022)), the significantly greater sensitivity of selected ion flow tube mass spectrometry (SIFT-MS) greatly reduces sample preparation times by eliminating matrix matching of blanks, while direct sample analysis provides significantly higher throughputs (Figure 1). Depending on the approach taken with sample prep (in parallel or on demand), headspace-SIFT-MS reports the first sample result four- to eight-fold faster than the compendium GC-FID method and has nine- to 14-fold higher daily sample throughput (Silva et al. (2022)).
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