Introduction
Ethylene oxide (EtO) is a widely used feedstock in the chemical industry (Wikipedia 1), including in the manufacture of polyethylene glycols (PEGs) used as surfactants and emulsifiers perfumes, cosmetics, and pharmaceuticals. It is also used widely as a sterilant in the pharmaceutical and medical implants industries because it bactericidal, sporicidal, and virucidal, while being compatible with a wide range of biomaterials with which radiation and heat sterilization are incompatible (Qiu et al. (2017)). However, the toxicity is not limited to microbes: it is mutagenic to humans (Aronson (2016)). For this reason, detection of trace ethylene oxide impurities is essential.eneous. The physicochemical characterization of such molecules is very challenging.
Polysorbate 80 is a polyethylene oxide product used as an emulsifier in various pharmaceuticals and is available under various trade names (Wikipedia 2), including Tween 80® . The United States Pharmacopeia (USP) monograph Polysorbate 80 (USP (2015)) describes the conventional gas chromatography-flame ionization detection (GC-FID) method for EtO analysis. This approach is slow both from the perspective of sample preparation (USP (2013)) and sample analysis. The rate-limiting step in sample preparation is the 6-hr purification of the PEG matrix for matching to the sample (1 mL of Polysorbate 80 in 1 mL of N,N- dimethylacetamide and 0.2 mL of water). Further, the GC-FID run time is 38 minutes per sample.
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