The European Directorate for the Quality of Medicines and HealthCare (EDQM) is holding a consultation into a quantification method for suspected adulteration with ethylene glycol (EG) and diethylene glycol (DEG).
 
Children have died after consuming syrups that were contaminated with EG and DEG, potentially deadly chemicals that can be illicitly substituted for pharmaceutical-grade excipients. The deaths led the European Pharmacopoeia Commission (EPC) to order the development of methods for detecting and quantifying the contaminants in the widely used excipients sorbitol and maltitol.
 
The EPC order has led to the drafting of a “Potential adulteration” section in four sorbitol and maltitol monographs. The proposed section describes a gas chromatography method to be used for the detection of harmful levels of EG and DEG when adulteration is suspected.
 
EDQM said this is the first time that a group of experts has proposed to add a “Potential adulteration” section as described in the European Pharmacopoeia (Ph. Eur.) General Notices.
 
Under the Ph. Eur., potential adulteration sections can apply to “monographs on substances for which an incident has occurred or which are at risk of deliberate contamination.” The Pharmacopoeia states that the requirements “apply to the whole supply chain, from manufacturers to users.”
 
The proposals are open for feedback until the end of the year.