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What is the limit of diethylene glycol and ethylene glycol?

May 29, 2025 Leave a message

The limits of diethylene glycol and ethylene glycol vary by industry and region. Here are some common regulations:

 

United States: The US FDA requires that the acceptable limit for diethylene glycol and ethylene glycol in high - risk drug components is no more than 0.10%2. The USP 30 - NF 25 stipulates that diethylene glycol in glycerin should be ≤ 0.1%

 

European Union: For materials and articles in contact with food, the EU has standards such as EN 13130 - 7:2004. It specifies methods for the determination of monoethylene glycol and diethylene glycol in food simulants, but there is no specific limit value given5. The European Pharmacopoeia 5.0 stipulates that diethylene glycol in glycerin should be ≤ 0.1%

 

Japan: The Japanese Pharmaceutical Excipients Specification 2006 requires that the content of diethylene glycol and similar substances in glycerin should be below 0.1%

 

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