| abstract |
A method of producing a cyclodextrin-panobinostat adduct having a concentration of less than 1000 parts per million (ppm) of acetone, tetrahydrofuran, dichloromethane, acetonitrile, dimethylformamide, and dimethyl sulfoxide (DMSO), comprising: a) providing a first solution aqueous comprising a buffering agent, the solution having a pH in the range of 2.0 to 4.0; b) dissolving the panobinostat in said first aqueous solution to provide a second aqueous solution; and c) mixing said second aqueous solution comprising panobinostat with a third aqueous solution comprising cyclodextrin to form a fourth aqueous solution comprising an adduct of cyclodextrinpanobinostat. |