Key Issue: Glycerin

Last Update: 10–Aug–2011

Contacts

  • Glycerin Monograph: Kevin Moore(ktm@usp.org or 1-301-816-8369)
  • Propylene Glycol Monograph: Kevin Moore (ktm@usp.org or 301-816-8369)
  • Sorbitol Solution and other Sugar Alcohol Monographs: Hong Wang (hw@usp.org or 301-816-8351)
  • Excipient Monograph Technical Services Support: Bob Lafaver, (rhl@usp.org or 301-816-8335)
  • Reference Standards Technical Support: RS Technical Service (rstech@usp.org or 301-816-8129)
  • Reference Standards Ordering: USP Customer Service (custsvc@usp.org or 800-227-8772)
  • Media: Laura Provan (lnp@usp.org or 301-816-8268)

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. Read More

The Glycerin Monograph was posted as a Revision Bulletin and became official May 1, 2009.

In addition, FDA recommended 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. Look for additional information on the USP Hot Topics: Propylene Glycol and Sorbitol Solution web page 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. Click on the link to order:

Download the latest USP Reference Standards Catalog

News

Frequently Asked Questions

USP Compendial Updates

Stay informed about any Revision Bulletin to the USP Glycerin monograph through USP’s free Compendial Updates email service.

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