BRIEFING

 Olmesartan Medoxomil Tablets. This proposal is based on the version of the monograph to be official on February 1, 2026. It is proposed to revise the monograph with the following changes:

1. Revise Identification A from maxima and minima UV absorption to UV spectrum match for the Sample solution and Standard solution from the Assay.

2. Revise the test for Organic Impurities as follows:

   • Replace the reference to the System suitability solution with a reference to the Standard solution for the Relative standard deviation requirement to align with expectations for modern chromatographic systems and supporting data.

   • Revise the concentration of the Sensitivity solution and Signal-to-noise ratio requirement to demonstrate acceptable chromatographic system sensitivity.

   • Add a note and Table 4 in the System suitability section to present relative retention times as an aid in peak assignment.

   • Revise Table 5 in the Acceptance criteria to list only the limits for specified degradation products, any unspecified degradation product, and total degradation products.

   • In the Acceptance criteria, replace the disregard limit of below 0.1% with a reference to User-Determined Reporting Thresholds 〈477〉 for user flexibility.

3. 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.

 (SM2: M. Fadadu)

 Case ID—SUB-965