US Pharmacopeia revises glycerin monograph

AORN Journal, June, 2008

Arevised glycerin monograph is scheduled for publication in the United States Pharmacopeia as a means to increase consumer safety and prevent fatalities associated with adulteration of the sweetener, according to a March 17, 2008, news release from the US Pharmacopeia (USP). The revised monograph includes an updated procedure for quantifying impurities in glycerin and a new procedure for identifying the presence of diethylene glycol.

Diethylene glycol, a poisonous chemical used in industrial solvents and antifreeze, has been found as an adulterant in glycerin, which is used as a sweetener in pharmaceutical syrups and various consumer products. In 1938, more than 100 US citizens died of poisoning from diethylene glycol. Since then, the USP has worked with the US Food and Drug Administration (FDA) to increase consumer safety.

The FDA issued a "Guidance for Industry Testing of Glycerin for Diethylene Glycol" in May 2007, emphasizing the importance of screening for the chemical. The revised monograph and FDA guidelines require any medication manufacturer using glycerin to prove diethylene glycol is not present in its product.

The revised monograph goes into effect on May 15, 2008. The USP currently is working to update additional monographs for ingredients that may also be susceptible to diethylene glycol contamination.

USP announces revised glycerin monograph [news release]. Rockville, MD: US Pharmacopeia; March 17, 2008.