BRIEFING

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

1. The proposed liquid chromatographic procedure in the Assay was validated with the XTerra MS C18 brand of column with L1 packing. The typical retention time for isosulfan blue is about 5 min.

2. The proposed liquid chromatographic procedure in the test for Organic Impurities was validated with the XTerra RP18 brand of column with L1 packing. The typical retention time for isosulfan blue is about 31 min.

 (SM4: R. Nguyen)

 Case ID—SUB-1039