L-Malic Acid → Sunitinib Malate

Participants

Reaction Steps

The mixture of sunitinib free base (5.0 gm), L-malic acid (1.8 gm) and water (75 ml) was heated to 80 deg C. to obtain a clear solution, stirred for 30 minutes at 80 deg C. and slowly cooled to room temperature. The solution was subjected to freeze drying at about −90 deg C. for 7 hours to obtain 6.5 gm of sunitinib malate crystalline form III.

Provenance & Evidence