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.

Changes in physical and chemical properties of niosome membrane induced by cholesterol: a promising approach for niosome bilayer intervention

“…To conrm complete TR removal, GC-MS (Agilent Technologies, Carian Saturn 2000, USA) was carried out. The detergent was detected according to the method previously described by Poss et al 41 The GC-MS analysis was performed using a Varian Saturn 2000/HP5973 GC-MS system (Agilent Technologies, Santa Clara, CA, USA).…”

Effects of gamma radiation on phase behaviour and critical micelle concentration of Triton X-100 aqueous solutions

“…2): a first region (0.1-5 kGy), where the CP value does not show significant changes, and a second region (5-50 kGy), characterized by a roughly linear decrease of CP. It is worthy to note that at higher doses (70 kGy), the CP value remains almost constant, and that the range where greater changes are observed is precisely the one comprising typical sterilization doses (15)(16)(17)(18)(19)(20)(21)(22)(23)(24)(25)(26)(27)(28)(29)(30).…”

“…Triton X-100 (a.k.a. octoxynol 9) is a commercially available surfactant used as a solvent detergent in numerous pharmaceutical applications including virus inactivation [20]. The cloud point (CP), a characteristic temperature in which micellar systems of nonionic surfactants show a reversible separation phenomenon, is a unique property that characterizes the fine balance between hydrophilic (head) and hydrophobic (tail) interactions occurring in a micellar solution [21].…”