Key Issue: Revision of Excipient Monographs Related to DEG & EG Adulteration

Propylene Glycol, Sorbitol Solution, Sorbitol Sorbitan Solution, Noncrystallizing Sorbitol Solution, Maltitol Solution

Last Updated: 10–Aug–2011

Contacts

  • 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)

Revised Monographs

Based on a request from the Food and Drug Administration (FDA) in February 2009, USP has revised and strengthened its monographs for five pharmaceutical excipients used in drug formulations-Propylene Glycol, Sorbitol Solution, Sorbitol Sorbitan Solution, Noncrystallizing Sorbitol Solution, and Maltitol Solution. These efforts are to assist in preventing future diethylene glycol (DEG) and ethylene glycol (EG) adulteration. Read More

The revisions to the above-named monographs include limits for DEG and EG, each at a level of not more than 0.10 percent in the Identification test. These revisions are consistent with the recent USP Glycerin monograph revision to help prevent future episodes of pharmaceutical adulterations with these poisonous chemicals.

The following revised monographs are posted as Revision Bulletins, and became official February 1, 2010.

Maltitol Solution has been more recently revised, and became official August 1, 2010.

Reference Standards

In addition to the USP Propylene Glycol, Sorbitol Solution, Maltitol and 1, 4–Sorbitan Reference Standards, USP has developed two new impurities Reference Standards for diethylene glycol and ethylene glycol to support these monograph revisions. Click on the link to order:

Download the latest USP Reference Standards Catalog

Web Meetings and Informal Comment Period

USP held two open microphone web meetings in March 2009 to communicate with stakeholders regarding FDA's request and to discuss method development for high-priority monographs. A third open microphone web meeting was held August 10, 2009. The following documents are available from these web meetings:

Open Microphone Web Meetings #1–2: March 16 & 17, 2009

Open Microphone Web Meeting #3: August 10, 2009, 10 AM–11 AM EDT

In addition to these Web meetings, on July 1, 2009, USP posted the methods for these monographs for informal comment with an August 14, 2009, deadline for comment submission. The following is a summary of comments received and USP responses.

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