BRIEFING

 Acamprosate Calcium. This proposal is based on the version of the monograph official as of May 1, 2020. It is proposed to revise the monograph with the following changes:

1. Revise Identification A to add 197A to provide the flexibility of using either 197A or 197K.

2. In the Assay, delete glacial acetic acid as it is not needed to establish the modified System suitability criteria.

3. In the test for Limit of Acamprosate Related Compound A, add a Sensitivity solution containing acamprosate related compound A and propose a Signal-to-noise ratio requirement.

4. In the test for Organic Impurities:

   • Replace the Standard solution with a solution containing USP Acamprosate Calcium RS and USP Acamprosate Related Compound C RS at a concentration level aligned with the proposed unspecified and specified impurity limits, respectively. Accordingly, add a Relative standard deviation requirement for each component.

   • Delete glacial acetic acid as it is not needed to establish the modified System suitability criteria.

   • Add a Sensitivity solution for the assessment of Signal-to-noise ratio in the Suitability requirements to align with the reporting threshold.

   • Revise the Analysis to add the quantitation equation for acamprosate related compound C using the corresponding USP Reference Standard.

   • Revise the table in the Acceptance criteria to list limits for specified impurities, any unspecified impurity, and total impurities.

   • Revise the Acceptance criteria to add a reference to User-Determined Reporting Thresholds 〈477〉 for user flexibility.

5. Update the USP Reference Standards section to include USP Acamprosate Related Compound C RS to support the proposed changes in the test for Organic Impurities.

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

 (SM4: R. Ivaturi)

 Case ID—SUB-1196