Evidence map›Paper›PMID 40401362›Full record

ArticleBioanalysis2025

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

Nicolas Abrigo, Susan Daniela Selaya, Adil Mohammad, Diaa Shakleya, Dustin G Brown, Jinhui Zhang, Valerie Pratt, Jody E Green, Amanda Degunia, Michael Bennett and 5 more

Abstract readValidation Study
In one paragraph

Article in Bioanalysis, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. High-throughput UPCAnalytical and bioanalytical chemistry · 2026
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

Nicolas AbrigoOffice of Pharmaceutical Quality Research, Center for Drug Evaluation and Research Food and Drug Administration, Silver Spring, MD, USA.
Susan Daniela SelayaOffice of Pharmaceutical Quality Research, Center for Drug Evaluation and Research Food and Drug Administration, Silver Spring, MD, USA.
Adil MohammadOffice of Pharmaceutical Quality Research, Center for Drug Evaluation and Research Food and Drug Administration, Silver Spring, MD, USA.
Diaa ShakleyaOffice of Pharmaceutical Quality Research, Center for Drug Evaluation and Research Food and Drug Administration, Silver Spring, MD, USA.ORCID 0000-0002-3649-0449
Dustin G BrownOffice of Pharmaceutical Quality Research, Center for Drug Evaluation and Research Food and Drug Administration, Silver Spring, MD, USA.
Jinhui ZhangOffice of Pharmaceutical Quality Research, Center for Drug Evaluation and Research Food and Drug Administration, Silver Spring, MD, USA.
Valerie PrattOffice of New Drugs, Center for Drug Evaluation and Research Food and Drug Administration, Silver Spring, MD, USA.
Jody E GreenOffice of New Drugs, Center for Drug Evaluation and Research Food and Drug Administration, Silver Spring, MD, USA.
Amanda DeguniaThe Children's Hospital of Philadelphia Research Institute, Abramson Research Center, Philadelphia, PA, USA.
Michael BennettThe Children's Hospital of Philadelphia Research Institute, Abramson Research Center, Philadelphia, PA, USA.
Kaitlyn BloomThe Children's Hospital of Philadelphia Research Institute, Abramson Research Center, Philadelphia, PA, USA.
Lynnette RogersThe Research Institute at Nationwide Childrens Hospital, Columbus, OH, USA.
Aiman Q KhanThe Research Institute at Nationwide Childrens Hospital, Columbus, OH, USA.
Robert O HeuckerothThe Children's Hospital of Philadelphia Research Institute, Abramson Research Center, Philadelphia, PA, USA.
Patrick J FaustinoOffice of Pharmaceutical Quality Research, Center for Drug Evaluation and Research Food and Drug Administration, Silver Spring, MD, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWhile Polyethylene glycol 3350 (PEG 3350) is approved by the USFDA for short term use by adults, it is commonly recommended for use in constipated children. Multiple reports of adverse events in children taking PEG 3350 raised safety concerns suggesting that low molecular weight species of PEG 3350 might be absorbed from the gut and cause side effects such as ethylene glycol (EG), diethylene glycol (DEG), and triethylene glycol (TEG). RESEARCH DESIGN AND

methodsThis article documents the development, validation, and application of analytical methods using GC-MS and GC-MS/MS for the quantitation of EG, DEG, and TEG in human plasma, serum, and urine.

resultsThe analytical range for EG, DEG, and TEG was 2-20 µg/mL. The sample preparation process involves derivatization using N,O-bis(trimethylsilyl) trifluoroacetamide with 1% trimethylchlorosilane in each biological matrices. Deuterated internal standards for each of the analytes were included to provide accurate quantitation of the glycol analytes.

conclusionsThe validated methods were applied to analyze samples a pilot study of children taking PEG 3350. DEG and TEG were detected at levels below the limit of quantitation. In summary, a platform of analytical methods was developed to evaluate glycol analogs in urine, serum, and plasma clinical samples.

Indexed as

Ethylene GlycolEthylene GlycolsEthylenesGas Chromatography-Mass SpectrometryPolyethylene GlycolsChildHumansdiethylene glycolEthylene GlycolEthylene GlycolsEthylenesPolyethylene Glycolstriethylene glycolclinical samplesdiethylene glycolethylene glycolGC-MSGC-MS/MSPolyethylene glycol 3350triethylene glycol

Identifiers

PMID40401362
PMCPMC12160607

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.