BRIEFING

 Omega-3 Free Fatty Acids. This proposal is based on the version of the monograph official as of December 1, 2022. On the basis of comments received, the following changes are proposed:

1. Revise the concentration and the hyperlink of the reagent "14% boron trichloride–methanol solution" to "12% boron trichloride–methanol solution" and add "14% boron trifluoride–methanol solution" as an alternative reagent for the preparation of System suitability solution 1 in the Content of EPA, DHA, and Total Omega-3 Free Fatty Acids test.

2. Add a hyperlink for the reagent "tetracos-15-enoic acid methyl ester" under System suitability solution 2 of the Content of EPA, DHA, and Total Omega-3 Free Fatty Acids test.

3. Revise the units for the Acceptance Criteria in Table 2 of the Content of EPA, DHA, and Total Omega-3 Free Fatty Acids test from "w/v" to "w/w" in order to match the resulting unit of the formula and the Definition.

4. Clarify that butylated hydroxytoluene is an antioxidant that may be present in the Omega-3 Free Fatty Acids ingredient added during production, as per the Definition.

5. Revise the Labeling section in which the average content of DHA and EPA are expressed "as free fatty acids" instead of "as free acids".

 Additionally, minor editorial changes have been made to update the monograph to current USP style.

 (NBDS: F. Tadjimukhamedov)

 Correspondence Number—C323996