Isopropyl Acetate → 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 slowly cooled to room temperature and the solution was added to isopropyl acetate (72 ml). The solution was stirred for 2 hours at room temperature and filtered. The solid obtained was washed with mixture of dimethyl sulfoxide (1 ml) and isopropyl acetate (4 ml) and dried at 60 deg C. under vacuum to obtain 4.3 gm of sunitinib malate crystal form I.

Provenance & Evidence