Beginning in 2006, several worldwide health incidences occurred due to products containing glycerin intentionally contaminated with DEG (so-called economic adulteration), resulting in hundreds of deaths. In response, USP received a letter from FDA in April 2007, requesting revision of the glycerin monograph to incorporate a DEG limit test. The FDA then published Guidance for Industry: Testing of Glycerin for Diethylene Glycol, which referenced USP's new glycerin monograph identification test. The new glycerin standard became official May 1, 2009, and at FDA's request, USP also published updated standards for several additional excipient monographs at risk for adulteration: sorbitol solution, sorbitol sorbitan solution, noncrystallizing sorbitol solution, propylene glycol, and maltitol solution.
Published Oct 7, 2010
