USP test for DEG and EG in Finished Dosage Forms

Date

February 28, 2025

Category

US Regulations

Description

On 28 February 2025 the USP posted a General Announcement regarding “Diethylene Glycol and Ethylene Glycol Testing Method for Finished Dosage Forms”.

Sadly, product contaminated with Diethylene Glycol (DEG) and Ethylene Glycol (EG) has resulted in the deaths of hundred across the world since 1937, with the most recent instances occurring in Africa with products that were manufactured in India. Most jurisdictions around the world now require rigorous testing for these contaminants in high risk excipients (e.g. glycerine, etc.).

USP indicate that there is also an urgent need to detect DEG and EG in finished dosage forms. FDA’s laboratory has developed and validated a test method using Gas chromatography-Mass spectrometry (GC-MS) for determination of EG and DEG in cough, cold, and allergy products containing glycerine. In close collaboration with the FDA, USP intends to post the method on the USP's Emerging Standards webpage around May 2025 to help analyse EG and DEG in finished drug dosage forms. USP welcomes stakeholders to evaluate this method and provide feedback.

Read More Here: Diethylene Glycol and Ethylene Glycol Testing Method for Finished Dosage Forms | USP-NF