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USP Seeks Comments on Proposed Identification Method for Maltitol Solution

Posted: January 21, 2010

Overview

USP has posted the draft compendial method for the high-priority monograph Maltitol Solution for informal public review and comment. Like the preceding four high-priority excipients Propylene Glycol, Sorbitol Solution, Sorbitol Sorbitan Solution, and Noncrystallizing Sorbitol Solution, USP is enabling a six-week informal comment period to allow users the opportunity to provide input on the proposed changes to the monograph, which will become official via Revision Bulletin. The deadline for informal comments is March 2, 2010. (Please Note: There will not be a subsequent formal comment period, only the final official Revision Bulletin.)

The proposed revision to the NF Maltitol Solution standard includes limits for diethylene glycol (DEG) and ethylene glycol (EG), each at a level of not more than 0.10 percent in the Identification test. This revision, based on a request from the Food and Drug Administration, is consistent with the recent four pharmaceutical excipients used in drug formulations – Propylene Glycol, Sorbitol Solution, Sorbitol Sorbitan Solution, and Noncrystallizing Sorbitol Solution monograph revisions – to help prevent future episodes of diethylene glycol (DEG) and ethylene glycol (EG) adulteration. Maltitol is the final high-priority monograph identified by USP and FDA to undergo these revisions.

Review the Proposed Method for Maltitol Solution  (51KB)

Projected Timeline for Maltitol Solution (subject to change)

  • Proposed Maltitol Solution Method Posted for Informal Comment: January 21, 2010
  • Informal Comments Due: March 2, 2010
  • Targeted Revision Bulletin Posting: April 30, 2010
  • Maltitol Solution Revised Monograph Official: August 1, 2010 (12-week implementation period)

Reference Standards

In addition to the USP Maltitol and Sorbitol Reference Standards, USP has developed two new impurities Reference Standards for diethylene glycol and ethylene glycol to support these monograph revisions.

USP Maltitol RS Order
USP Sorbitol RS Order
USP Ethylene Glycol RS Order
USP Diethylene Glycol RS Order

Download the entire USP Reference Standards Catalog.

Web Content

USP's Compendial Updates
To keep informed about any Revision Bulletins to the USP Maltitol Solutionand 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)
    Maltitol 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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