The U.S. Pharmacopeial (USP) Convention has announced a revised Glycerin monograph in the United States Pharmacopeia (USP), an official compendium of the United States. The revision strengthens safety nets to prevent serious and potentially fatal health hazards associated with diethylene glycol-contaminated glycerin. Glycerin is used as a sweetener in formulations of many pharmaceutical syrups and in other consumer articles as well, such as toothpaste. Diethylene glycol is a poisonous chemical used in industrial solvents and antifreeze.
Over many years, accidental or intentional adulteration of drugs with diethylene glycol has occurred many times and in many countries, most recently in Panama in 2007 and, notably for the United States, in 1938. The 1938 episode killed over 100 American citizens, many of them children, and led to passage of the Federal Food, Drug and Cosmetic Act. Since that time, FDA and USP have worked together to prevent other such disastrous events.
In May 2007, FDA issued a "Guidance for Industry Testing of Glycerin for Diethylene Glycol." This Guidance emphasized the importance of screening ingredients and products for the presence of diethylene glycol. FDA and USP also worked together to change the current Glycerin monograph in USP. This change will require drug product manufacturers using glycerin -- not just the glycerin manufacturer -- to prove that diethylene glycol is not present, using the USP Glycerin monograph.
"This change in the USP Glycerin monograph is one of many safety nets that help assure U.S. citizens that the drugs they use are of good quality," said Roger L. Williams, M.D., USP's executive vice president and chief executive officer. "In some areas, these safety nets still need strengthening. For example, other useful ingredients similar to glycerin may be susceptible to diethylene glycol contamination. USP is working now to adjust monographs for these ingredients, just as it has the USP Glycerin monograph."
The revision of the USP Glycerin monograph becomes official May 15, 2008. It addresses adulteration/contamination of glycerin with the following changes:
1. Revision of Identification--B. In the Identification B procedure of the monograph, a gas-liquid chromatographic with flame ionization detection (GC/FID) test will be employed to confirm the absence or presence of glycerin, diethylene glycol and ethylene glycol by a peak at the relative retention times for glycerin, diethylene glycol and ethylene glycol. Where a peak is present for either of the impurities in this procedure at their respective relative retention times, the monograph will direct the user to quantify the impurities.
2. Replace the test "Limit of diethylene glycol and related compounds." A new procedure, Diethylene glycol and ethylene glycol impurities, capable of quantifying diethylene glycol and ethylene glycol at or above the Limit of quantitation (0.025%) is added. This diethylene glycol and ethylene glycol impurities test will be added to ascertain the level at which these impurities are present.
The revised Glycerin monograph also will appear in Supplement 2 to USP 31--NF 26, which will be published in June 2008.
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