BRIEFING

 Methocarbamol Tablets. This proposal is based on the version of the monograph official as of May 1, 2020. The following revisions are proposed:

1. Replace Identification A with a test based on the UV spectrum agreement of the major peak in the Assay to eliminate the use of chloroform. Accordingly, add the use of a diode array detector in the Chromatographic system of the Assay.

2. Update the Run time and Suitability requirements in the Assay for flexibility, consistency with Chromatography 〈621〉, System Suitability, and alignment with modern expectations.

3. Revise the Dissolution test as follows:

   • Add the Buffer, Mobile phase, System suitability solution, and Chromatographic system from the Assay procedure to align with current USP style.

   • Add the Standard stock solution, and revise the Standard solution and Sample solution based on FDA-approved specifications.

   • Revise the Analysis to incorporate the dilution factor for the Sample solution in the calculation equation.

4. Revise portions of the chromatographic procedure in the Organic Impurities test to align with current expectations. The following revisions are proposed based on laboratory data, as needed:

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

   • Remove the Tailing factor requirement because there are sufficient system suitability tests for the procedure.

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

   • Update the table in the Acceptance criteria to list limits for specified degradation products, any unspecified degradation product, and total degradation products to align with the International Council for Harmonisation Q3B guidelines. The relative response factors are also listed in this table.

   • Revise the Acceptance criteria to add a reference to User-Determined Reporting Thresholds 〈477〉 for user flexibility.

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

 (SM4: T. Bililign)

 Case ID—SUB-1134