Type of Posting: Revision Bulletin
Posting Date: 30–Apr–2010; updated 31–Mar–2011
Official Date: 01–Aug–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 Maltitol Solution monograph. The purpose for the revision is to include a Limit Test for diethylene glycol and ethylene glycol in response to a request by the U.S. Food and Drug Administration.
The Maltitol Solution Revision Bulletin supersedes the currently official Maltitol Solution monograph. The Revision Bulletin will be incorporated in Second Supplement to the USP 33–NF 28 Reissue.
Should you have any questions, please contact Hong Wang (301-816-8351 or hw@usp.org).