BRIEFING

 Quetiapine Extended-Release Tablets. This proposal is based on the version of the monograph official as of December 1, 2024. It is proposed to revise the monograph with the following changes:

1. Replace 197F in Identification A with the UV spectrum agreement of the major peak from the Sample solution and the Standard solution, as obtained in the proposed Assay. This revision avoids the use of a toxic solvent in the preparation of the sample.

2. Add filter pore size in Dissolution Test 7, Test 9, and Test 12, based on the supporting data.

3. In Dissolution Test 1, Test 3, Test 6, Test 7, Test 9, Test 11, and Test 12, remove the use of volumetric solutions and update the reagent references, as volumetric solutions are not required.

4. In the test for Organic Impurities:

   • Add a Sensitivity solution aligned with the expected reporting threshold and include an appropriate Suitability requirement for Signal-to-noise ratio.

   • Add Table 14 and a note in the System suitability section to present relative retention times as an aid in peak assignment.

   • Update the Relative retention time of fumaric acid in Table 14 to two decimal places to be consistent with the current USP style based on the supporting data.

   • In the Acceptance criteria:

     • Add a reference to User-Determined Reporting Thresholds 〈477〉 for user flexibility and delete the statement for the disregard limit.

     • Revise Table 15 to list only the relative response factor and the acceptance criteria.

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

 (SM4: S. Singireddy)

 Case ID—SUB-2119, SUB-3280