Type of Posting: Notice of Intent to Revise
Posting Date: 18–Dec–2015
Targeted Official Date: 01–Sep–2016
Expert Committee: Monographs—Non-Botanical Dietary Supplements 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 USP Monographs— Non-Botanical Dietary Supplements Expert Committee, the Expert Committee responsible for monographs applicable to dietary supplements, and certain drug products and drug substances, intends to revise the Aspartic Acid monograph via an Interim Revision Announcement (IRA).
Based on the submissions and supporting data received, the Expert Committee proposes to revise the Aspartic Acid monograph with the following changes to the Related Compounds test:
- Increase the amount of hydrochloric acid added to the Sample solution to aid the dissolution of aspartic acid in the test for the Related Compounds.
- Add a NOTE to disregard the hydrochloric acid peak that may be observed in the chromatogram of the Sample solution in the test for the Related Compounds.
It is anticipated that the revision will be published as a proposed IRA in Pharmacopeial Forum 42(2) [Mar.–Apr. 2016] pursuant to section 7.02 of the Rules and Procedures, with a comment deadline of May 31, 2016. If approved by the Expert Committee, the IRA will be published on USP’s website on July 29, 2016 and become official on September 1, 2016.
Should you have any questions, please contact Huy Dinh, Scientific Liaison to the Monographs—Non-Botanical Dietary Supplements Expert Committee (301-816-8594 or htd@usp.org).