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USP Revises Four High-Priority Pharmaceutical Excipient Monographs: Propylene Glycol, Sorbitol Solution, Sorbitol Sorbitan Solution, and Noncrystallizing Sorbitol Solution

Updated: January 21, 2010

What's New

November 11, 2009

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

The proposed revisions to the USP Propylene Glycol, Sorbitol Solution, Sorbitol Sorbitan Solution, and Noncrystallizing Sorbitol Solution standards 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 will become official February 1, 2010, allowing for a 12-week implementation period.


Informal Commentary


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.

USP Ethylene Glycol RS Order
USP Diethylene Glycol RS Order
USP Maltitol RS Order
USP 1, 4 – Sorbitan RS Order
USP Sorbitol RS Order
USP Propylene Glycol RS Order

Download the entire 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.

Web Content

USP's Compendial Updates
To keep informed about any Revision Bulletins to the USP Propylene Glycol, Sorbitol Solution and other high–priority sugar alcohol monographs, sign up for USP's free Compendial Updates email service.

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USP Contacts

    Propylene Glycol Monograph: Kevin Moore ( or 301–816–8369)
    Sorbitol Solution and other Sugar Alcohol Monographs: Hong Wang ( or 301–816–8351)
    Glycerin Monograph: Robert Lafaver ( or 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)

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