BRIEFING

 Bosutinib. Because there is no existing USP monograph for this drug substance, a new monograph based on validated methods of analysis is proposed.

1. The liquid chromatographic procedure in the Assay was validated using the Xbridge BEH C18 brand of column with L1 packing. The retention time for bosutinib is about 4 min.

2. The liquid chromatographic procedure in the Organic Impurities test was validated using the YMC Triart C18 brand of column with L1 packing. The retention time for bosutinib is about 35 min.

 This monograph is contingent on FDA approval of a product that meets the proposed monograph specifications. Please see the Pending Monograph Guideline for additional information.

 Description and solubility information: White to yellowish-tan powder. Soluble in dimethylsulfoxide; sparingly soluble in acetone; practically insoluble in water.

 The "Water content" limits in the proposal may be appropriate only for the dihydrate forms. FDA-approved manufacturers utilizing other hydrates are encouraged to share their limits with USP.

 (SM3: L. Lasker)

 Case ID—SUB-1499