BRIEFING

 Escitalopram Tablets. This proposal is based on the version of the monograph to be official on June 1, 2026. It is proposed to make the following changes:

1. In the Assay:

   • Update the Sample solution preparation in response to comments received.

   • Add a Tailing factor requirement for the Standard solution in the System suitability based on supporting data.

2. In Dissolution Test 1, update the Medium preparation to more closely align with the original submission and current practices.

3. In Dissolution Test 2, update the Buffer preparation and add a Run time to more closely align with supporting information.

4. In the test for Organic Impurities:

   • Add a Sensitivity solution, corresponding Signal-to-noise ratio requirement, and a Tailing factor requirement to strengthen the System suitability requirements.

   • Add a table and update the Note in the System suitability section to present relative retention times as an aid in peak assignment. Update the chemical information within Table 1.

   • Revise Table 2 in the Acceptance criteria to list only the limits for specified degradation products, any unspecified degradation product, and total degradation products.

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

5. Update the storage condition in the Packaging and Storage section to be consistent with approved product inserts.

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

 (SM4: Y. Yang)

 Case ID—SUB-1001