Dimethyl Sulfoxide → Sunitinib Malate

Participants

Reaction Steps

The mixture of sunitinib free base (5.0 gm), L-malic acid (1.8 gm) and dimethyl sulfoxide (25 ml) was heated to 80 deg C. to obtain a clear solution, stirred for 30 minutes at 80 deg C. The solution was cooled to 55-60 deg C. and acetone (150 ml) was added to the solution at 55-60 deg C., stirred for 2 hours at 55-60 deg C. The solution was further cooled to room temperature, stirred for 1 hour at room temperature and filtered. The solid obtained was washed with acetone (15 ml) and dried the solid at 60 deg C. under vacuum to obtain 5.2 gm of sunitinib malate crystal form I

Provenance & Evidence