BRIEFING

 Olmesartan Medoxomil. This proposal is based on the version of the monograph official as of June 1, 2025. It is proposed to revise the monograph with the following changes:

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

2. Remove the use of an internal standard from Identification B.

3. In the Assay:

   • Remove the use of an internal standard from the test.

   • The Acceptance criteria in the Definition and Assay are revised from 98.5%−101.5% to 98.0%−102.0% to be consistent with the chromatographic assay.

   • Add Tailing factor requirements of 0.8−1.8 based on the supporting data.

   • Widen the Relative standard deviation requirement from NMT 0.5% to NMT 0.73% to align with the proposed changes and typical requirements from chromatographic systems.

   • Remove the Resolution requirement, as the other System suitability requirements are sufficient.

4. In the Organic Impurities test:

   • Clarify the preparation for Buffer.

   • Add the Sensitivity solution and the corresponding Signal-to-noise ratio criterion.

   • In the System suitability section, revise the Relative standard deviation requirement from the System suitability solution to the Standard solution.

   • Add a Note and Table 2 in the System suitability section to present relative retention times as an aid in peak assignment. Revise Table 3 in the Acceptance criteria to list only the specified impurities, any unspecified impurity, and total impurities.

   • Delete the chemical name from the footnote for Olmesartan medoxomil related compound A in Table 2 because this chemical name is listed under the USP Reference Standards section.

   • Update the trivial name for Olmesartan medoxomil N-alkyl impurity in Table 2 and Table 3 to be consistent with USP style.

   • In the Acceptance criteria, replace the disregard limit of below 0.05% with a reference to User-Determined Reporting Thresholds 〈477〉 for user flexibility.

5. In the Analysis section of the Limit of Acetone test, revise "peak response of acetone" to "peak response ratio of acetone and 1-butanol" for the Sample solution and Standard solution.

6. Update the chemical name for Olmesartan medoxomil related compound A in the USP Reference Standards section to be consistent with current chemical information.

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

 (SM6: M. Fadadu)

 Case ID—SUB-2036