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![]() USP Glycerin InformationLast Updated: February 25, 2009
Glycerin Monograph RevisionsAt the request of the Food and Drug Administration (FDA), USP has revised and strengthened its Glycerin Monograph to prevent future diethylene glycol (DEG) and ethylene glycol (EG) adulteration. The USP Excipient Monographs 1 Expert Committee has approved revisions to the monograph to include a 0.10% limit of DEG and EG in the Identification test of the USP Glycerin Monograph. The Glycerin Monograph has been posted as a Revision Bulletin in the New Official Text section of the USP Web site, and will become official May 1, 2009. Note: The Glycerin Monograph Revision Bulletin supersedes the monograph in USP 32-NF 27 until it is printed in the USP-NF Second Supplement, which will be released June 1, 2009. In addition, FDA recommends that USP revise monographs for Propylene Glycol and Sorbitol Solution to include a limit for DEG in the Identification test, consistent with USP Glycerin monograph revision. USP is currently addressing these and other high-risk excipients, including, Maltitol Solution, Sorbitol Sorbitan Solution, and Noncrystallizing Sorbitol Solution. Look for additional information at this Web site as USP revises these monographs. Reference StandardsIn addition to the USP Glycerin Reference Standard, USP has developed two new impurities reference standards for diethylene glycol and ethylene glycol to support in the monograph.
Download the entire USP Reference Standards Catalog. Future ActivitiesMarch 16 and 17, 2009 (subject to change): Open Microphone Web Meeting #1
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