BRIEFING

 Tavaborole. Because there is no existing USP monograph for this drug substance, a new monograph based on validated methods of analysis is proposed. The liquid chromatographic procedures in the Assay and Organic Impurities test were validated using the Luna Phenyl-Hexyl brand of column with L11 packing. The typical retention time for tavaborole is about 16 min.

 Description and Solubility information: White to off-white powder. Freely soluble in ethyl alcohol.

 (SM1: I. Salahudeen, J. Li)

 Case ID—SUB-775