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Validated GC-MS methods to detect ethylene, diethylene, and triethylene glycol in serum, plasma, and urine samples

Nicolas Abrigo1,2, Susan Daniela Selaya1,3, Adil Mohammad1

  • 1Office of Pharmaceutical Quality Research, Center for Drug Evaluation and Research Food and Drug Administration, Silver Spring, MD, USA.

Bioanalysis
|May 22, 2025
PubMed

Insights

This study developed analytical methods to detect ethylene glycol (EG), diethylene glycol (DEG), and triethylene glycol (TEG) in children using Polyethylene glycol 3350 (PEG 3350). The methods found DEG and TEG at very low levels, below quantification limits in a pilot study.

Area of Science:

  • Analytical Chemistry
  • Clinical Chemistry
  • Pharmacology

Background:

  • Polyethylene glycol 3350 (PEG 3350) is FDA-approved for adults but commonly used in children for constipation.
  • Concerns exist regarding potential absorption of low molecular weight PEG 3350 species, leading to toxic byproducts like ethylene glycol (EG), diethylene glycol (DEG), and triethylene glycol (TEG).

Purpose of the Study:

  • To develop and validate sensitive analytical methods for quantifying EG, DEG, and TEG in human biological matrices.
  • To assess the presence of these glycols in children using PEG 3350.

Main Methods:

  • Gas chromatography-mass spectrometry (GC-MS) and GC-MS/MS were employed for quantitation.
  • Sample preparation involved derivatization and the use of deuterated internal standards.
  • Analytical methods were validated for human plasma, serum, and urine.

Main Results:

  • The analytical methods achieved a range of 2-20 µg/mL for EG, DEG, and TEG.
  • In a pilot study of children using PEG 3350, DEG and TEG were detected below the limit of quantitation.

Conclusions:

  • A robust platform of analytical methods was established for evaluating glycol analogs in clinical samples.
  • The findings suggest minimal detectable levels of DEG and TEG in children using PEG 3350.
Abstract

Keywords:
GC-MSGC-MS/MSPolyethylene glycol 3350clinical samplesdiethylene glycolethylene glycoltriethylene glycol

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