Type of Posting: Intent to Revise
Posting Date: 27–Dec–2013
Targeted Official Date: Interim Revision Announcement, 01–Sep–2014
Expert Committee: Monographs—Excipients
In accordance with section 7.05(c) of the 2010–2015 Rules and Procedures of the Council of Experts, this is to provide notice that the USP Monographs USP Excipients Expert Committee intents to revise the Polysorbate 20 monograph.
Comments with supporting data were received that indicate the specification of stearic acid in the test for Composition of Fatty Acids should be revised. The Expert Committee proposes to revise the the specification of stearic acid in the test for Composition of Fatty Acids from "<7.0%" to "<11.0%"
It is anticipated that the revision will be published as a Proposed Interim Revision Announcement in PF 40(2) [Mar–Apr 2014] pursuant to section 7.02 of the Rules and Procedures. The comment period for this revision ends on May 31, 2014. In the absence of any adverse comments the proposed IRA will become official on September 01, 2014.
Should you have any questions, please contact Hong Wang, Scientific Liaison to the Excipients Expert Committee (301-816-8351 or firstname.lastname@example.org).