Polymorph of regadenoson and process for preparation thereof
Processes are provided for the preparation of a stable polymorphic form C of regadenoson, the process involving steps of a) obtaining a solution of regadenoson in benzyl alcohol solvent, b) maintaining the reaction mixture of step a) to about 10° C. to about 90° C., and c) isolating the stable polymorphic form C of regadenoson. Polymorphic form C may be characterized by an x-ray powder diffraction pattern with peaks at about 6.1, 10.2, 10.6, 19.0 and 25.4.±0.2 degrees 2-theta.
1. A process for the preparation of stable polymorphic form C of regadenoson, comprising the steps of:
a) obtaining a solution of Regadenoson in benzyl alcohol solvent;
b) maintaining the reaction mixture of step a) to about 10° C. to about 90° C.; and
c) isolating the stable polymorphic form C of regadenoson.
2. The process of claim 1 , wherein in step b), the mixture is heated to a temperature from about 70° C. to about 75° C.
3. The process of claim 1 , wherein in step c), the mixture is cooled to a temperature of about 25° C. to about 30° C.
4. The process of claim 1 , wherein the obtained stable polymorph form C has purity greater than 99%.