JOURNAL ARTICLE

A New Headspace Gas Chromatography Method for Determination of Ethylene Oxide and Dioxane in Polyethylene Glycols.

  • Published In: Journal of Chromatographic Science, 2025, v. 63, n. 2. P. 1 1 of 3

  • Database: Academic Search Ultimate 2 of 3

  • Authored By: Premaratne, Gayan; McAdoo, Andrew; Tian, Jingzhi; Rustum, Abu 3 of 3

Abstract

This article focuses on the development and validation of a new headspace gas chromatography (HSGC) method for determining ethylene oxide (EO) and 1,4-dioxane (Dioxane) in bulk polyethylene glycols (PEGs). The method uses an Agilent DB-624 column and helium carrier gas with flame ionization detection, achieving separation of EO, Dioxane, and other residual solvents such as methanol (MeOH), methyl formate (MF), and acetaldehyde (Acetal) within an 18-minute run time. Unlike existing HSGC methods prescribed in the United States Pharmacopeia (USP) monograph <228> and European Pharmacopoeia (EP) monograph <2.4.25>, which suffer from co-elution of EO and MF leading to inaccurate EO quantification, the new method provides improved specificity, sensitivity, and shorter analysis time. Validated according to ICH/VICH guidelines, this method is suitable for routine quality control analysis of EO and Dioxane in PEGs of various chain lengths and can be adapted for determining other residual solvents in pharmaceutical excipients.

Additional Information

  • Source:Journal of Chromatographic Science. 2025/02, Vol. 63, Issue 2, p1
  • Document Type:Article
  • Subject Area:Chemistry
  • Publication Date:2025
  • ISSN:0021-9665
  • DOI:10.1093/chromsci/bmaf011
  • Accession Number:182906339
  • Copyright Statement:Copyright of Journal of Chromatographic Science is the property of Oxford University Press / USA and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

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