BRIEFING

 Edaravone Injection. Because there is no existing USP monograph for this drug product, a new monograph based on validated methods of analysis is proposed:

1. The liquid chromatographic procedure in the Assay was validated using the MCI-GEL ODS-1HU brand of column with L1 packing. The typical retention time for edaravone is about 8 min.

2. The liquid chromatographic procedure in the test for Organic Impurities, Procedure 1 was validated using the MCI-GEL ODS-1HU brand of column with L1 packing. The typical retention time for edaravone is about 4 min.

3. The liquid chromatographic procedure in the test for Organic Impurities, Procedure 2 was validated using the MCI-GEL ODS-1HU brand of column with L1 packing. The typical retention time for edaravone is about 11 min.

 (SM4: D. Singh)

 Case ID—SUB-1019