ROCKVILLE, Md., March 17 The U.S. Pharmacopeial (USP)Convention today announced a revised Glycerin monograph in the United StatesPharmacopeia (USP), an official compendium of the United States. The revisionstrengthens safety nets to prevent serious and potentially fatal healthhazards associated with diethylene glycol-contaminated glycerin. Glycerin isused as a sweetener in formulations of many pharmaceutical syrups and in otherconsumer articles as well, such as toothpaste. Diethylene glycol is apoisonous chemical used in industrial solvents and antifreeze. Over manyyears, accidental or intentional adulteration of drugs with diethylene glycolhas occurred many times and in many countries, most recently in Panama in 2007and, notably for the United States, in 1938. The 1938 episode killed over 100American citizens, many of them children, and led to passage of the FederalFood, Drug and Cosmetic Act. Since that time, FDA and USP have worked togetherto prevent other such disastrous events.
In May 2007, FDA issued a "Guidance for Industry Testing of Glycerin forDiethylene Glycol." This Guidance emphasized the importance of screeningingredients and products for the presence of diethylene glycol. FDA and USPalso worked together to change the current Glycerin monograph in USP. Thischange will require drug product manufacturers using glycerin -- not just theglycerin manufacturer -- to prove that diethylene glycol is not present, usingthe USP Glycerin monograph.
"This change in the USP Glycerin monograph is one of many safety nets thathelp assure U.S. citizens that the drugs they use are of good quality," saidRoger L. Williams, M.D., USP's executive vice president and chief executiveofficer. "In some areas, these safety nets still need strengthening. Forexample, other useful ingredients similar to glycerin may be susceptible todiethylene glycol contamination. USP is working now to adjust monographs forthese 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 followingchanges:
The revised Glycerin monograph also will appear in Supplement 2 to USP 31-NF 26, which will be published in June 2008. For more information, pleasecontact Robert Lafaver, USP scientist and liaison to the Excipient Monographs1 Expert Committee, at 301-816-8335 or [email protected]
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USP -- Advancing Public Health Since 1820
The United States Pharmacopeia (USP) is a private, non-profit, standards-setting organization that advances public health by ensuring the quality andconsistency of medicines, promoting the safe and proper use of medications,and verifying ingredients in dietary supplements. These standards, which arerecognized worldwide, are developed by a unique process of public involvementthrough the contributions of volunteers representing pharmacy, medicine, andother health care professions, as well as science, academia, government, thepharmaceutical industry, and consumer organizations. For more informationabout USP and its four public health programs, visithttp://www.usp.org/newscenter.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 g