BRIEFING

 Telmisartan and Amlodipine Tablets. This proposal is based on the version of the monograph official as of December 1, 2020. On the basis of comments received, the following changes are being proposed:

1. In the Assay:

   • Clarify the concentration of USP Telmisartan RS and USP Amlodipine Besylate RS in the Standard solution to reflect Standard stock solution 1 and Standard stock solution 2.

   • Correct the concentrations of USP Amlodipine Besylate RS in the Standard solution for all strengths in Table 1.

   • Rename the Sample solution as the Sample stock solution and clarify the preparation. Include Table 2 to present the nominal concentrations of telmisartan and amlodipine for all strengths in the Sample stock solution to provide clarity to users.

   • Add a Sample solution preparation based on the Sample stock solution and include Table 3 to present the final nominal concentrations of telmisartan and amlodipine for all strengths in the Sample solution to provide clarity to users.

   • Revise the definition of the variable C_U in the Analysis by removing the term "besylate" from "amlodipine besylate" to be consistent with the Acceptance criteria for the Definition and the Assay.

2. In the calculations in Dissolution Test 1, delete the variable D and its definition, as it is not needed.

3. In the Organic Impurities test:

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

   • Add the chemical name for amlodipine mannitol adduct in Table 5 based on supporting data. Also, delete "Peak due to besylate", as it is not needed under Besylate.

   • Clarify the System suitability requirement by including two API peak names.

   • Replace the numerical reporting threshold in the Acceptance criteria section with a reference to User-Determined Reporting Thresholds 〈477〉 for user flexibility.

   • Update Table 6 in the Acceptance criteria section to list the limits for specified degradation products, any unspecified degradation product, and total degradation products.

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

 (SM6: S. Parepalli)

 Case ID—SUB-2264