BRIEFING

 Red Yeast Dry Extract. Because there is no existing USP monograph for this dietary ingredient, a new monograph based on validated methods of analysis is being proposed. The proposal for this dietary ingredient that appeared in PF 48(6) has been canceled and is being replaced with a new proposal because a caution label needs to be added and hexane needs to be replaced with cyclohexane to reduce toxicity of the solvent. In addition, USP Ankaflavin RS was degraded and will be removed from the monograph due to concerns about its stability. The following revisions are being proposed:

1. Add a caution notice with a link under the title.

2. In Identification A:

   • Remove USP Ankaflavin RS from Standard solution A.

   • Use cyclohexane instead of hexane in the Development solvent system.

   • Modify the System suitability and Acceptance criteria accordingly.

3. Modify the Acceptance criteria of Identification B.

4. In the Content of Monascin and Ankaflavin test:

   • Remove USP Ankaflavin RS from Standard solution A.

   • Remove ankaflavin from the Tailing factor and Relative standard deviation.

   • Add a conversion factor (F) to the calculation.

5. Add a caution label in the Labeling section.

 (BDSHM: C. Ma)

 Case ID—SUB-1709