Isopropyl Acetate → Sunitinib Malate

Participants

Reaction Steps

Sunitinib free base (5.0 gm) and L-malic acid (1.8 gm) was added to dimethyl sulfoxide (25 ml), and the mixture was heated to 80 deg C. to obtain a clear solution, stirred for 30 minutes at 80 deg C. Isopropyl acetate (120 ml) was added to the solution at 80 deg C. and stirred for 2 hours at 80 deg C. The solution was slowly cooled to room temperature and stirred for 1 hour at room temperature. The contents are filtered and the solid obtained was washed with isopropyl acetate (15 ml), and then dried the solid at 60 deg C. under vacuum to obtain 5.0 gm of sunitinib malate crystal form I.

Provenance & Evidence