BRIEFING

 Bromelain. This proposal is based on the version of the monograph official as of December 1, 2023. On the basis of comments received, the following changes are being proposed:

1. Correct the abbreviation for EDTA in the Buffer in the Assay.

2. Correct the instructions for the preparation of the Sample solution in the Assay.

3. Provide additional instructions of the Analysis in the Assay.

4. Change the equation used for the calculation of the enzyme activity in the Assay to provide additional instructions.

5. Correct the unit of measure used for the label claim in the calculation of the percentage of the labeled amount of the enzyme activity in the Assay.

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

 (NBDS: M. Monagas)

 Case ID—SUB-250