New FDA Guidance: Screening for Diethylene Glycol and Ethylene Glycol Contamination

Andrew D. Schaefer, Manager, Analytical Method Development & Validation, Biopharmaceutical Raw Materials, Eurofins BioPharma Product Testing, Andrew.Schaefer@bpt.eurofinsus.com

Since the notorious sulfanilamide elixir diethylene glycol poisoning of 1937, which resulted in over a hundred deaths, and the subsequent enactment of the FD&C Act in 1938, the modern U.S. Food and Drug Administration (FDA) has been monitoring poisoning incidents in the U.S. and abroad. However, despite decades of modernisation efforts for high-risk drug components monographed in the United States Pharmacopeia (USP) and the inclusion of chapter <469>, numerous deaths have still been documented globally as a result of contaminated products with not only DEG but ethylene glycol (EG). Both DEG and EG largely make their way into products via poor manufacturing practices of raw materials or contamination of solvents and excipients used in production. Consequently, in May 2023, the FDA published Guidance for Industry: Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and other High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol.

FDA guidance recommends testing all containers of many high-risk materials, including some polyethylene glycols, polysorbates, sugar alcohols, fatty acid oils, and nonionic surfactants used as excipients. While several of these materials are monographed with DEG and EG specification limits or are captured in the general chapter, the USP list is not yet all inclusive.

Eurofins’ core mission is to contribute to a safer and healthier world by providing customers with innovative and high-quality laboratory, research and advisory services. To that end, Eurofins BPT has established a fast, high-quality and robust approach to monitor these high-risk components for DEG and EG according to USP <469>, for not only the monographed materials, but any material that presents a risk to patient safety. By using the Eurofins Platform Approach, not only can materials in USP <469> be accepted for rapid GMP testing, but a turn-key service for non-monographed materials is ready to go at a moment’s notice to validate the method. The Eurofins BPT Raw Materials laboratory in Lancaster, PA, is one of the largest single raw material laboratories in the world, with a network of companion laboratories in North America and abroad designed to deliver fast and reliable quality control testing to our customers. Eurofins provides a one-stop-shop for full GMP raw material testing covering chemistry, biochemistry, microbiological and viral services. To learn more, Contact Us.