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Rapid Analysis of Ethylene Oxide and Acetaldehyde in Polysorbate 80 by SIFT-MS

Abstract


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.

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