(all-E)-2-(3,7,11,15,19,23,27-Heptamethyl-2,6,10,14,18,22,26-octacosaheptaenyl)-3-methyl-1,4-naphthalenedione [2124-57-4]
BRIEFING
Menaquinone-7. This proposal is based on the version of the monograph official as of May 1, 2020. On the basis of comments received, the following changes are proposed:
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Revise the Definition to remove menaquinone-6 and its limits.
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Replace the Identification B procedure based on ultraviolet-visible spectroscopy with the retention time-based procedure previously listed as Identification C.
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Revise the Assay and the Isomeric Purity tests to replace "peak response" with "peak height" in the calculations of the percentage of menaquinone-7 and the percentage of cis-menaquinone-7, respectively.
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Delete the procedure for the content of menaquinone-6 and its Acceptance criteria from the Assay and add a new test for Limit of Menaquinone-6 with a revised limit of NMT 1.0%.
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Revise the Isomeric Purity test to add clarification to the procedure in order to take other impurities of Menaquinone-7 into account.
Additionally, minor editorial changes have been made to update the monograph to current USP style.
(NDBS: F. Tadjimukhamedov)
Case ID—SUB-2183