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July 24, 2026BMC Pharmacology and ToxicologyOpen Access

Development and validation of a GC–MS method for the determination of ethylene glycol and diethylene glycol in pharmaceutical syrups

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Authors

MAMuhammad Amirul AmilMinistry of HealthMAMuhammad Shahariz Mohamad AdzibMinistry of HealthNBNur Baizura BujangMinistry of Health

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Implication

Randomized trial developed a reliable GC-MS method to measure contaminants in syrups, highlighting safety needs.

Key Points

  • The aim was to develop and validate a GC-MS method for detecting ethylene glycol and diethylene glycol in pharmaceutical syrups.
  • Developed a GC-MS method following ICH Q2(R2) guidelines.
  • Validated the method with commercially available syrup products.
  • Applied the method to 51 syrup samples for post-market surveillance.
  • Detected ethylene glycol in 13 out of 51 syrup samples.
  • Two samples had measurable levels of ethylene glycol at 0.09% v/v, below regulatory limits.
  • Diethylene glycol was not found in any sample.

Cite This Study

Amil et al. (2026) studied this question.

synapsesocial.com/papers/6a6300c2395161722cd159eehttps://doi.org/10.1186/s40360-026-01184-2
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1A Selective Gas Chromatography–Tandem Mass Spectrometry Method for Quantitation of Ethylene and Diethylene Glycol in Paediatric Syrups2024 · 12 citations
  2. 2Ethylene glycol and diethylene glycol impurities determination and assay tests for selected pharmaceutical syrups collected from Addis Ababa, Ethiopia2026
  3. 3B-277 Validation of an Enzymatic Method for Quantification of Ethylene Glycol in Human Serum2025
  4. 4B-325 Evaluation of Ethylene Glycol Stability in Blood and Serum: Impact of Pre-Analytical Conditions and Performance Comparison of an Automated Enzymatic Assay vs. Gas Chromatography-Mass Spectrometry in Clinical Toxicology2025
  5. 5Different regulatory approaches to excipient requirements: the case of EG/DEG contamination risk in pharmaceuticals2026