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USP Glycerin Information

Last Updated: February 25, 2009

• News Release on new standards for heparin and glycerin (02/04/09)
• USP Announces Strengthened Glycerin Standard to Help Protect Consumers from Poisoned Products (02/04/09)

Glycerin Monograph Revisions

At 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 Standards

In 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.

USP Ethylene Glycol RS	Order
USP Diethylene Glycol RS	Order
USP Glycerin RS	Order

Future Activities

March 16 and 17, 2009 (subject to change): Open Microphone Web Meeting #1
USP will host open microphone web meetings on March 16 and 17, 2009 to discuss method development for Propylene Glycol and Sorbitol Solution, and other related monographs.

• Register
• FDA's Request to USP to Revise the USP monographs for Propylene Glycol and Sorbitol Solution  (305KB)

Web Content

USP's Compendial Updates
To keep informed about any Revision Bulletin to the USP Glycerin monograph, sign up for USP's free Compendial Updates email service.
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Related Links

• FDA publication of "Guidance for Industry Testing of Glycerin for Diethylene Glycol."
• FDAs initial request to USP to revise the USP Glycerin monograph.  (71KB)

USP Contacts

• Propylene Glycol Monograph: Kevin Moore ( or 301-816-8369)
• Sorbitol Solution Monograph: Hong Wang ( or 301-816-8351)
• Glycerin Monograph: Robert Lafaver ( or 1–301–816–8335)
• Media: Laura Provan ( or 301-816-8268)
• Reference Standards Technical Support: RS Technical Service ( or 301-816-8129)
• Reference Standards Ordering: USP Customer Service ( or 800-227-8772)