BRIEFING

 Orphenadrine Citrate Extended-Release Tablets. This proposal is based on the version of the monograph official as of February 1, 2022. It is proposed to make the following changes:

1. Add Identification B based on the UV spectrum agreement of the major peak of the Sample solution and Standard solution, as proposed in the Assay.

2. In the Assay:

   • Clarify the Sample stock solution and Standard solution preparation based on the original submission.

   • Update the Detector to include the information to run Identification B.

   • Add Run time and update the Relative standard deviation requirement to align with the expectations of modern chromatography.

3. In Dissolution Test 1, add Run time based on the original submission.

4. In Dissolution Test 2, correct the sample dilution and revise the Analysis to include the sample dilution factor based on the original submission.

5. In the test for Organic Impurities:

   • Clarify the Sample solution preparation to be consistent with the original submission.

   • Add a Sensitivity solution based on the anticipated maximum daily dose and add a corresponding Signal-to-noise ratio requirement in the Suitability requirements.

   • Add a table and a Note to the System suitability section to present relative retention times as an aid in peak assignment. Update the names and footnotes within Table 4.

   • Revise the Acceptance criteria section to include a reference to User-Determined Reporting Thresholds 〈477〉 for user flexibility and to update the names within Table 5.

6. Update the chemical names for USP Orphenadrine Related Compound B RS and USP Orphenadrine Related Compound C RS in the USP Reference Standards section.

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

 (SM4: Y. Yang)

 Case ID—SUB-1015