Type of Posting: Notice of Intent to Revise
Posting Date: 30–Oct–2015
Targeted Official Date: Interim Revision Announcement, 01–July–2016
Archive Date: 24–Jun–2016
Expert Committee: Monographs—Excipients 1 Expert Committee
In accordance with section 7.04 (c) of the Rules and Procedures of the Council of Experts, this is to provide notice that the Monographs—Excipients 1 Expert Committee intends to revise the Glyceryl Tristearate NF monograph.
Comments with supporting data were received that indicate the specification of arachidic acid in the test for Fatty Acid Composition should be revised. The Expert Committee proposes to revise the specification of arachidic acid in the test for Fatty Acid Composition from "0.0%−0.5%" to "0.0%−1.0%.”
It is anticipated that the proposed revision will be published as an Interim Revision Announcement (IRA) in Pharmacopeial Forum 42(1) [Jan.–Feb. 2016] pursuant to section 7.02 of the Rules and Procedures. The comment period for this revision ends on March 31, 2016. In the absence of any adverse comments the proposed IRA will become official on July 01, 2016.
Should you have any questions, please contact Hong Wang, Scientific Liaison to the Monographs—Excipients 1 Expert Committee (301-816-8351 or hw@usp.org).