BRIEFING

 Perilla Fruit. Because there is no existing USP monograph for this dietary ingredient, a new monograph based on validated methods of analysis is proposed. The proposal for this dietary ingredient which appeared in PF 50(1) [Jan.–Mar. 2024] has been canceled and is being replaced with a new proposal based on the comments received. The following revisions are being proposed:

1. In Identification A:

   • Replace n-hexane with cyclohexane in the Developing solvent system.

   • Change the sonication time from 30 min to 10 min in both Standard solution B and the Sample solution.

   • Change Derivatization reagent A into 10 mg/mL of 2-aminoethyl diphenylborinate.

   • Change Derivatization reagent B into anisaldehyde sulfuric acid reagent.

   • Modify the description of System suitability and Acceptance criteria accordingly.

2. Add a caution label in the Labeling section.

 (BDSHM: C. Ma)

 Case ID—SUB-1719