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Propylene Glycol Public Health Risk

What you need to know about the Propylene Glycol Public Health Risk



What is Propylene Glycol?

Propylene Glycol is a clear, colourless, viscous liquid. It is used as an excipient in medicines. For example: As a humectant in topicals As a preservative in solutions As a co-solvent in aerosols, parenterals, oral solutions and topicals As a plasticiser in aqueous film-coating As a solvent in e-cigarettes.


What is the public health risk?

Despite its widespread use, there have been 190 fatalities in Indonesia due to propylene glycol being adulterated with ethylene glycol. Furthermore, the contamination of ethylene glycol and diethylene glycol in medicines presents a public health risk. Ethylene glycol and diethylene glycol are known contaminants of propylene glycol. Ethylene glycol is the toxic component of antifreeze and a class 2 solvent. Diethylene glycol is known to be toxic and has a wide use in plastic manufacturing and organic synthesis.


How can it be avoided?

Due to the public health risk associated with these contaminants, the European Pharmacopeia monograph for propylene glycol has been updated. These contaminants are now controlled: Ethylene glycol: Not more than 620 ppm Diethylene glycol: Not more than 0.10% Moreover, the analytical method for testing these contaminants has been updated. This update will come into force in January 2025. However, Agency’s have been aware of this issue for a while and will continue requesting the control of these contaminants in propylene glycol.


What do you need to do now?

If you are using propylene glycol as an excipient in your medicinal products, take these actions: Check that you are using Ph.Eur. grade propylene glycol. This means the supplier guarantees the compliance of it with the current version of the Ph.Eur. Check that there are limits for ethylene glycol and diethylene glycol in the suppliers certificate of analysis. The limits may not match the updated propylene glycol monograph. However, ensure that an update of these limits in line with the new limits is under way, as some Agency’s may request this even though the update is not yet effective due to the public health issue.


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Download the updated propylene glycol monograph below:


Revised monograph on Propylene glycol (0430) (1)
.pdf
Download PDF • 732KB

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