BRIEFING

 Daunorubicin Hydrochloride Injection. Because there is no existing USP monograph for this drug product, a new monograph based on validated methods of analysis is proposed. The liquid chromatographic procedures used in the Assay and test for Organic Impurities are validated with the Kromasil C18 brand of column with L1 packing. The typical retention time for daunorubicin is about 12 min.

 (SM1: P. Pabba)

 Correspondence Number—C231415