Type of Posting: Notice of Intent to Revise
Posting Date: 28–Apr–2017
Targeted Official Date: 01–Dec–2018, In-Process Revision
Expert Committee: Non-Botanical Dietary Supplements
In accordance with section 7.04 (c) of the 2015–2020 Rules and Procedures of the Council of Experts, this is to provide notice that the Non-Botanical Dietary Supplements Expert Committee intends to revise the Krill Oil monograph.
The purpose for the revision is to broaden the range limits for myristic acid, ratio of palmitic acid to myristic acid, oleic acid, and eicosapentaenoic acid in the Fatty acid profile of the Identification A test to align with the new data recently obtained from the products on the market. Also, the revision involves lowering the limit of astaxanthin in the Definition and the test for Astaxanthin content from NLT 0.01% to NLT 0.005% to reflect the new data on the stability studies of astaxanthin.
Minor editorial changes have been made to update the monograph to the current USP style.
It is anticipated that the proposed revision will be published in Pharmacopeial Forum 43(4) [Jul.–Aug. 2017] pursuant to section 7.02 of the Rules and Procedures. The comment period for this revision will end on September 30, 2017. In the absence of any adverse comments the proposed revision will be submitted to ballot for official adoption in the Second Supplement to USP 41-NF 46, which will become official on December 1, 2018.
Should you have any questions, please contact Huy Dinh, Senior Scientific Liaison to the Non-Botanical Dietary Supplements Expert Committee (301-816-8594 or firstname.lastname@example.org).