Published:Journal of Chromatographic Science,
ISSN 0021-9665Volume
41, Number 8, September 2003, pp. 410-417
Determination of 1,4-Dioxane Impurity Levels in Triton X-100
Raw Material by Gas Chromatography with Mass Spectrometric Detection
Mitchell Poss, Tom Couch, Alex Odufu, Jennifer McCann, James
Mellon, Ben Melnick, and Dennis Jenke*
Technology Resources, Baxter Healthcare Corporation, Round Lake, IL 60073
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 detecton. 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.
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