BRIEFING

 Propafenone Hydrochloride. This proposal is based on the version of the monograph official as of May 1, 2020. On the basis of comments received, the previous proposal that appeared in PF 45(4) [Jul.–Sep. 2018] was canceled and is replaced with the following proposal. It is proposed to revise the monograph with the following changes:

1. Add 197A as an alternate test method for Identification A to allow flexibility to users.

2. Add Identification B based on chromatographic retention time agreement as obtained in the proposed Assay and rename Identification B to Identification C accordingly.

3. Replace the titration procedure with an HPLC procedure for the Assay. The proposed liquid chromatographic procedure was validated using the Inertsil C8 brand of column with L7 packing. The typical retention time for propafenone is about 5 min.

4. In the Organic Impurities test:

   • Delete the extraneous Run time information because it is not needed for a gradient method.

   • Add the Sensitivity solution and the corresponding Signal-to-noise ratio criterion.

   • Add a note and table in the System suitability section to present relative retention times as an aid in peak assignment. Update Table 3 to include the relative retention time for propafenone. Update trivial names and chemical names in Table 3 and Table 4 to be consistent with USP style.

   • Clarify the system suitability requirements for Resolution and Relative standard deviation.

   • Replace the disregard statement in the Acceptance criteria with a reference to User-Determined Reporting Thresholds 〈477〉 for user flexibility.

5. Remove the nonspecific tests for Melting Range or Temperature and Clarity of Solution because the monograph contains sufficient tests to ensure the quality of the material.

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

 (SM2: F. Gu)

 Case ID—SUB-1311