BRIEFING

 Bacillus coagulans. This proposal is based on the version of the monograph official as of July 1, 2023. On the basis of comments received, it is being proposed to make the following revisions:

1. Replace the primer sequences and acceptance criteria for strain GBI-30, 6086 in Table 1 of Identification B.

2. Revise the PCR sample preparation and PCR amplification cycle for strain GBI-30, 6086 in Table 2 of Identification B.

3. Revise the sample weight, heat shock directions, and dilutions for the Sample preparation in the Assay.

4. Replace some reagents with USP reagents to properly describe the specifications required for the corresponding tests.

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

 NBDS: B. Koshy

 Case ID—SUB-1775