EDQM: Ph. Eur. Pre-publishes Revised Propylene Glycol Monograph
The EDQM pre-published the revised monograph on Propylene glycol (0430) adopted by the European Pharmacopoeia Commission (EPC) at its 177th session held on 21 and 22 November 2023. The revision took part as a response to the public health risk posed by the discovery of ethylene glycol (EG) and diethylene glycol (DEG) contamination in several medicinal products in Africa and Asia and confirmed cases of propylene glycol adulterated with EG with over 190 fatalities in Indonesia.
The monograph now includes a test for EG and DEG. Furthermore, the limit for EG was changed to 620 ppm. An additional system suitability criterion for the symmetry factor for the EG and DEG peaks has been included and, following thorough verification of the procedure, changes have also been made to the solution preparation method. Details on all changes can be found in the "History Section" of the EDQM Knowledge Database.
To speed up the process, the EPC has made the monograph immediately available on the website of the EDQM. All users should be aware of the change and the extended analytical procedure. The monograph will be officially published in Ph. Eur. Supplement 11.6 in July 2024 and will come into force on 1 January 2025.
Source:
EDQM: Newsroom
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