USPUSP-NF
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Maca Root Macamides Dry Extract

BRIEFING

 Maca Root Macamides Dry Extract. A new monograph for this dietary ingredient is being proposed. Based on comments received, the proposal published in PF 50(4) has been canceled and is being replaced with a new proposal. The following validated methods of analysis had been proposed: The liquid chromatographic procedure in the test for Content of Macamides was conducted using the Agilent ZORBAX SB-C18 brand of column with 3.5-µm L1 packing. The typical retention times for N-benzyllinolenamide, N-benzyllinoleamide, and N-benzylpalmitamide were 13.7, 20.1, and 28.6 min, respectively. In addition, the following revision is being proposed:

  • In Identification B, revise the content ratio of N-benzylpalmitamide to N-benzyllinolenamide from NLT 5 to NLT 4, and revise the content ratio of N-benzylpalmitamide to N-benzyllinoleamide ratio from NLT 3 to NLT 2.

 (BDSHM: M. Monagas)

 Case ID—SUB-3517

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