title: Determination of 1,4-dioxane impurity levels in Triton X-100 raw material by gas chromatography with mass spectrometric detection.
abstract: Triton X-100 (octoxynol 9) is a commercially available surfactant used as a solvent detergent in numerous pharmaceutical applications including virus inactivation. A byproduct formed during its synthesis is 1,4-dioxane, the cyclic dimer of ethylene oxide and a possible carcinogen to humans. The United States Pharmacopoeia (USP) contains a labor-intensive 1,4-dioxane test for Triton X-100. The method couples vacuum distillation to extract the 1,4-dioxane from the Triton X-100 matrix followed by gas chromatography (GC) using a packed column with flame-ionization detection. In order to provide a more automated and specific test methodology, a headspace GC-mass spectrometry (MS) method has been developed for this application. Analyte quantitation is accomplished by the method of standard additions. The automated sample preparation, coupled with the specificity inherent in high-efficiency capillary column separations together with single-ion MS detection, results in an assay that is more efficient, accurate, and precise than the USP procedure. Performance characteristics of the headspace GC-MS method are contrasted with those characteristics of the USP methodology.
authors.affiliation: Technology Resources, Baxter Healthcare Corporation, Round Lake, IL 60073, USA.
authors.forename: Mitchell
authors.initials: M
authors.lastname: Poss
authors.forename: Tom
authors.initials: T
authors.lastname: Couch
authors.forename: Alex
authors.initials: A
authors.lastname: Odufu
authors.forename: Jennifer
authors.initials: J
authors.lastname: McCann
authors.forename: James
authors.initials: J
authors.lastname: Mellon
authors.forename: Ben
authors.initials: B
authors.lastname: Melnick
authors.forename: Dennis
authors.initials: D
authors.lastname: Jenke
mesh_terms: D004146:Dioxanes / Q000032:analysis*; D008401:Gas Chromatography-Mass Spectrometry / Q000379:methods*; D017830:Octoxynol / Q000737:chemistry*; D013501:Surface-Active Agents / Q000737:chemistry*
chemical_list: D004146:Dioxanes; D013501:Surface-Active Agents; D017830:Octoxynol; C025223:1,4-dioxane