The European Pharmacopoeia Commission (EPC) has officially pre-published the updated Propylene Glycol monograph . This significant development, adopted during the 177th session on November 21-22, 2023, comes in the wake of rising public health concerns.

Recent incidents of ethylene glycol (EG) and diethylene glycol (DEG) contaminations in medicinal products have been linked to several fatalities, particularly a notable case in Indonesia. In a decisive response, the EPC has enhanced the monograph to include a test for EG and DEG.

Understanding the critical nature of these public health risks, the EPC has made this revised monograph accessible on the EDQM website. This early release provides users with crucial information about the impending changes and the corresponding analytical procedure.

The revision of the monograph, set to be officially published in Ph. Eur. Supplement 11.6 in July 2024 and effective from January 1, 2025, includes several crucial updates. Based on feedback from public consultation, adjustments have been made, including changing the EG limit to 620 ppm, in line with general chapter 5.4 on Residual solvents and the ICH Q3C guideline.

Additional updates feature a system suitability criterion for EG and DEG peaks and modifications to the solution preparation method. The monograph now also includes an infrared (IR) spectrophotometry identification test and an updated procedure for the Acidity test. Users can find comprehensive details on these changes in the history section of the EDQM Knowledge Database.

For further information and to stay updated on this critical issue, visit the EDQM website.