BRIEFING

 Levodopa. This proposal is based on the version of the monograph official as of May 1, 2020. The following changes are being proposed:

1. Revise the Assay as follows:

   • Remove USP Levodopa Related Compound B RS from System suitability solution as it is not needed to establish system suitability nor in the calculations.

   • Add requirements for the Autosampler temperature and Run time to align with the validated procedure.

   • Replace the references to the System suitability solution with references to the Standard solution for the Tailing factor and Relative standard deviation requirements to align with expectations for modern chromatographic systems and supporting data.

2. Revise the test for Organic Impurities as follows:

   • Reduce the concentration of the Standard solution, to align with the limit of any unspecified impurity.

   • Add a Sensitivity solution and a Signal-to-noise ratio in the Suitability requirement to demonstrate acceptable chromatographic system sensitivity.

   • Remove the Tailing factor in the Suitability requirement because the remaining requirements are sufficient.

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

   • Revise the table in the Acceptance criteria to list only the limits of specified impurities, any unspecified impurity, and total impurities.

   • Further, revise the Acceptance criteria to add a reference to User-Determined Reporting Thresholds 〈477〉 for user flexibility. For more information, please see the USP Compendial Notice “New Chapter 〈477〉 User-Determined Reporting Thresholds and its Implementation in USP–NF Monographs”.

3. Remove the reference to USP Levodopa Related Compound B RS from the USP Reference Standards section as it is no longer included in the proposed System suitability solution.

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

 (SM4: Q. Huynh)

 Case ID—SUB-222