Diethylene Glycol (DEG) and Ethylene Glycol (EG)
Limit test for DEG and EG by GC
The determination of DEG and EG is a current topic. The WHO has published alerts for 2022 and 2023 (WHO alerts No. 6/2022, No. 7/2022, No. 1/2023, No. 4/2023, No. 5/2023 and No. 6/2023). These alerts deal with DEG and EG impurities in medical products and the potential harm to patients. The intake of contaminated products can lead to serious harm or even death. It is important to detect and remove these substandard products from circulation to prevent harm to patients.
For this reason, both the FDA and the EDQM have addressed the determination of DEG and EG.
The EDQM has pre-published the monograph propylene glycol on this topic to warn users of the upcoming change. At the 177th session of the European Pharmacopoeia Commission, it was also agreed to look closer into potentially revising monographs on substances on risk of adulteration with EG and DEG and to liaise with international stakeholders on the topic.
The FDA has published the guidance for industry on testing DEG and EG, which is effective immediately. According to the FDA, this guidance is intended to "alert pharmaceutical manufacturers, fillers, repackers, and suppliers to the potential public health hazard posed by glycerin and other high-risk drug components contaminated with DEG or EG."
Examples of high-risk drug components that may contain DEG or EG:
- Glycerin
- Propylene Glycol
- Maltitol Solution
- Hydrogenated Starch Hydrolysate
- Sorbitol Solution
- Polyethylene glycol (only MW <1000),
- Diethylene glycol monostearate
- Polyethylene glycol monomethylether 350/550 (only MW <600)
- Polysorbate 20/40/60/80
- Polyoxyl 15 Hydroxystearate
- Polyoxyl 20 Cetostearyl Ether
- Polyoxyl 8 Stearate
- Octoxynol 9
- Nonoxynol 9
Does this guide apply to you?
Do you need a DEG and EG analysis?
We are pleased to inform you that we have experience with the testing of DEG or EG in various substances, e.g. the limit value test for DEG and EG by GC described in the monograph Glycerol has been successfully established in our laboratory. Get in touch with us and we will be happy to work out a solution for testing your products together.
