BRIEFING

 Menaquinone-7 Preparation. This proposal is based on the version of the monograph official as of May 1, 2024. On the basis of comments received, the following changes are proposed:

1. Add a new sample preparation procedure for a solid Preparation form of menaquinone-7 for Identification A and the test for Content of Menaquinone-7.

2. Revise the  Content of Menaquinone-7, Isomeric Purity, and Limit of Menaquinone-6 test procedures to replace "peak response" with "peak height" in the calculations of the content of menaquinone-7, the percentage of cis-menaquinone-7, and the content of menaquinone-6, respectively.

3. Revise the Acceptance criteria in the Limit of Menaquinone-6 test procedure.

4. Revise the Labeling section to indicate if concentrated Menaquinone-7 Extract is present and which Procedure the Preparation uses in Identification A and the test for Content of Menaquinone-7.

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

 (NDBS: F. Tadjimukhamedov)

 Case ID—SUB-1606