USP Announces Revised Glycerin Monograph(imilar to glycerinmay be susceptible to ...)

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. For more information, please contact Robert Lafaver, USP scientist and liaison to the Excipient Monographs 1 Expert Committee, at 301-816-8335 or rhl@usp.org. For media inquiries, please email mediarelations@usp.org.

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