End-To-End Solutions: Ethylene Glycol (EG) & Diethylene Glycol (DEG)

Chemical contamination in pharmaceutical products can have severe consequences for public health. Specifically in medicinal syrups, ethylene glycol (EG) and diethylene glycol (DEG) are two toxic substances that could be found as contaminants in these products. They are typically used as industrial solvents and antifreeze agents that can be fatal even in small amounts, especially for children.

Since October 2022, the World Health Organization (WHO) has issued six global medical product alerts for over-the-counter medicines contaminated with DEG and EG. In Indonesia, at least 195 child deaths were attributed to EG and DEG contamination, while in Gambia, West Africa, 70 child deaths were suspected to be caused by similar contamination. This alarming trend has led to an estimated 300 fatalities in children worldwide.

Pharmaceutical excipients such as propylene glycol, glycerol, and sorbitol, are commonly used in medicinal syrup to enhance solubility, taste, and texture. However, these raw materials are prone to contamination by toxic substances like EG and DEG. Symptoms of accidental ingestion of contaminated syrup can be severe, including abdominal pain, vomiting, altered mental state and kidney injury, which often leads to death. 

To test pharmaceutical products for DEG and EG, Gas Chromatography (GC) is a widely used analytical technique. The minimum safe levels for humans for ingested DEG and EG are not known with certainty, but a detection level of 0.10% for each substance (based on the USP method) is considered adequate for screening raw materials and finished products from a safety point of view, although laboratories may also adopt Indonesia BPOM’s stricter limit of 0.006%.