New control of ethylene glycol and diethylene glycol in Macrogols (1444) published for comment by EDQM

European Directorate for the Quality of Medicines & HealthCare (EDQM) introduced a new analytical procedure for the detection and control of ethylene glycol (EG) and diethylene glycol (DEG) in pharmaceutical excipients. So it revised the monograph in the Ph. Eur. monograph for Macrogols (1444) .  Interested parties are encouraged to review the draft text and submit comments till 30th of September 2026.

Recent incidents involving contaminated or deliberately adulterated materials have highlighted the need for robust analytical procedures for the detection and control of ethylene glycol (EG) and diethylene glycol (DEG) in pharmaceutical excipients. These toxic contaminants remain a focus of attention for regulatory authorities and pharmacopoeias worldwide due to the risks they pose to patient safety.

As part of the European Pharmacopoeia’s (Ph. Eur.) ongoing efforts to strengthen safeguards against EG and DEG contamination and adulteration of pharmaceutical products and to make detection of these impurities more robust, a new analytical procedure for their determination has been introduced in the Ph. Eur. monograph Macrogols (1444) which covers 12 grades of macrogol, a substance also known as polyethylene glycol. The revised monograph has been published in Pharmeuropa 38.3 for public consultation.

The proposed text introduces a new gas chromatography (GC) procedure employing a capillary column, making it possible to quantify the impurities via a derivatisation step and the use of an internal standard. It also proposes revised limits for EG and DEG. While the current monograph describes a combined limit for ethylene glycol and diethylene glycol, the proposed text establishes individual limits for each contaminant: 620 ppm for ethylene glycol and 0.10 per cent for diethylene glycol. Both substances are also well-known process impurities especially in low-molecular mass grades of macrogols.

The new procedure included in this draft revised text follows other Ph. Eur. initiatives aimed at expanding the control of EG and DEG in pharmaceutical excipients, such as the recently adopted Propylene glycol (0430) and Glycerol (0496) monographs, or the ongoing activities on dedicated EG/DEG tests that will soon be proposed for liquid sorbitol and maltitol.

Interested parties are encouraged to review the draft text and submit comments, together with any relevant analytical data generated using the proposed GC procedure or another procedure, during the consultation period (deadline: 30 September 2026). Actual values from batches of pharmaceutical quality currently on the market are essential to ensure the proposed limits are fit for purpose.

Instructions for submitting comments are available in the “How to comment” guide. Comments from states parties to the European Pharmacopoeia Convention should be sent to the responsible national pharmacopoeia authority (NPA); comments from other countries or from industry associations should be sent to the European Directorate for the Quality of Medicines & HealthCare (EDQM) via the EDQM HelpDesk.

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Source: edqm, European Directorate for the Quality of Medicines & HealthCare, website: New control of ethylene glycol and diethylene glycol in Macrogols (1444) published for comment – European Directorate for the Quality of Medicines & HealthCare