USPUSP-NF
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Vitamin K
1,4-Naphthalenedione
 2-Methyl-3-(3,7,11,15-tetramethyl-2-hexadecenyl)
 Phylloquinone
 Phytonadione C31H46O2 Formula wt: 450.71
 [84-80-0] S5Z3U87QHF phytonadione, (e)-

BRIEFING

 Vitamin K. FCC 14. On the basis of comments and information received, the following revisions are proposed in the Assay:

  1. Remove the factor of 1.56 from the Analysis formula.

  2. Revise the Analysis calculation statement to determine percentage rather than quantity.

  3. Revise the Assay to enhance the clarity.

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

 This proposal is targeted for publication in the First Supplement to FCC 15.

 (FI: T. Xu)

 Case ID—SUB-2193

USP REFERENCE STANDARDS FOR PURCHASE

USP Phytonadione RS
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