BRIEFING

 Sour Jujube Seed. This proposal is based on the version of the monograph official as of December 1, 2021. As part of the USP monograph modernization effort, it is proposed to use a single HPTLC method for identifying both flavone C-glycosides, which was originally Identification A, and triterpenoid glycosides, which was originally Identification B. The following changes to Identification A are proposed:

1. Revise the Standard solution A preparation to include both USP Spinosin RS and USP Jujuboside A RS.

2. Revise the Standard solution B preparation to use 0.5 g of USP Ziziphus jujuba spinosa Seed Dry Extract RS.

3. Replace the Sample solution and Developing solvent system with the preparations originally used in the omitted Identification B.

4. Add a preparation for Derivatization reagent C and, in the Analysis, a procedure for treating the plate with Derivatization reagent C after examining under long-wave UV light and then examining under white light, which was originally done in the omitted Identification B.

5. Update the System suitability and Acceptance criteria accordingly based on the test results from the changed method.

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

 (BDSHM: C. Ma)

 Correspondence Number—C318863