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Revision Bulletin

Noncrystallizing Sorbitol Solution

Posting Date: 30 October 2009; updated 26 February 2010
Official Date: 1 February 2010
Expert Committee: Excipient Monographs 1


In accordance with the Rules and Procedures of the 2005-2010 Council of Experts, the Excipient Monographs 1 Expert Committee has revised the monograph to include a Limit Test for diethylene glycol and ethylene glycol due to a request by the U.S. Food and Drug Administration.

The Noncrystallizing Sorbitol Solution Revision Bulletin supersedes the currently official monograph and will be incorporated into the First Supplement to the USP 33–NF 28 Reissue.

Should you have any questions, please contact Hong Wang (301-816-8351 or .

Download the Noncrystallizing Sorbitol Solution Revision Bulletin  (94KB)

Download the Sorbitol Solutions Informal Commentary  (47KB)