Apicore US LLC

Piyush D Fadadu

Ravishanker Kovi

Jayaraman Rao Kannapan

Ashish Naik

Ananda Babu Thirunavakarasu

Piyush B Thumar

Novel processes for making the N-pyrrazole substituted 2-adenosine derivative regadenoson and a novel polymorph thereof. The novel polymorph of regadenoson designated form H and drug substances and pharmaceutical compositions including the novel polymorph H are disclosed.

Process of making regadenoson and novel polymorphs thereof

Process of making regadenoson and novel polymorph 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&#xb0; C. to about 90&#xb0; 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.&#xb1;0.2 degrees 2-theta.

Polymorph of regadenoson and process for preparation thereof

Growing community of inventors

Gujarat, India

Piyush D Fadadu