Tools to Ensure Safe Medicines: New Monograph Tests in USP-NF

Abstract

This paper describes USP-NF compendial updates to six high-priority excipient monographs: Glycerin, Propylene Glycol, Sorbitol Solution, Sorbitol Sorbitan Solution, Noncrystallizing Solution and Maltitol Solution. The USP- NF revisions arose from the Food and Drug Administrations (FDAs) requests to include, as part of each monographs Identification test, a limit test to detect the presence of Diethylene Glycol (DEG), a toxic adulterant. These revisions align with the 2007 FDA Guidance for Industry: Testing of Glycerin for Diethylene Glycol [1], that drug product manufacturers perform a specific identity test for DEG on all containers of all lots of glycerin before glycerin is used in the manufacture and preparation of drug products. This paper describes several risk factors due to a complex global excipient supply chain, nonspecific specifications, inadequate supply chain qualification, and poor understanding of regulations. Strengthening and conformance to compendial specifications is one of the tools necessary to mitigate risk and help prevent the next DEG adulteration that is part of USPs efforts to ensure safe medicines.