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<p>A gas chromatography-mass spectrometry (GC-MS) method was developed for the simultaneous determination of ethylene chlorohydrin (ECH) and ethylene glycol (EG) residues in disposable infusion sets sterilized with ethylene oxide (EO). Samples were extracted with acetonitrile at 60&#xa0;°C for 4&#xa0;h using a sample/solvent ratio of 0.4&#xa0;g/mL. Chromatographic separation was achieved on a DB-WAX capillary column with a programmed temperature gradient. Detection was performed in selected ion monitoring (SIM) mode. The method exhibited good linearity in the range of 0.025–2.50&#xa0;µg/g for ECH and 0.125–2.50&#xa0;µg/g for EG. The limits of detection (LODs) and quantification (LOQs) were 0.008–0.04&#xa0;µg/g and 0.025–0.125&#xa0;µg/g, respectively. The recoveries at three spiked levels (0.125, 0.25, and 1.25&#xa0;µg/g) ranged from 94.87 to 108.63% with relative standard deviations (RSDs) between 0.62 and 7.88%. The validated method is sensitive, accurate, and robust, providing a reliable approach for assessing the risks associated with EO-related residues in disposable infusion sets. This method provides a reliable tool for safety evaluation of EO-sterilized medical devices.</p>

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Gas chromatography-mass spectrometry method for simultaneous determination of ethylene chlorohydrin and ethylene glycol residues in disposable infusion sets

  • 期刊论文

  • 发表日期：

    2026年5月12日

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  • Ruojin Liu,
  • Baoyu Liu,
  • Wenliang Shao

摘要

A gas chromatography-mass spectrometry (GC-MS) method was developed for the simultaneous determination of ethylene chlorohydrin (ECH) and ethylene glycol (EG) residues in disposable infusion sets sterilized with ethylene oxide (EO). Samples were extracted with acetonitrile at 60 °C for 4 h using a sample/solvent ratio of 0.4 g/mL. Chromatographic separation was achieved on a DB-WAX capillary column with a programmed temperature gradient. Detection was performed in selected ion monitoring (SIM) mode. The method exhibited good linearity in the range of 0.025–2.50 µg/g for ECH and 0.125–2.50 µg/g for EG. The limits of detection (LODs) and quantification (LOQs) were 0.008–0.04 µg/g and 0.025–0.125 µg/g, respectively. The recoveries at three spiked levels (0.125, 0.25, and 1.25 µg/g) ranged from 94.87 to 108.63% with relative standard deviations (RSDs) between 0.62 and 7.88%. The validated method is sensitive, accurate, and robust, providing a reliable approach for assessing the risks associated with EO-related residues in disposable infusion sets. This method provides a reliable tool for safety evaluation of EO-sterilized medical devices.