Patent ID: 11891455
Assignee: GALIMEDIX THERAPEUTICS INC
Field: Pharmaceuticals (Chemistry)
Classification: CPC C  A | IPC A  C

Claim 7:
8. A method of preparing ultrapure Form I of compound (R)-2-[2-amino-3-(indol-3-yl)propionylamino]-2-methylpropionic acid, characterized by an X-ray powder diffraction pattern displaying peaks at °2θ (d value Å) angles 6.75 (13.095), 10.19 (8.678), 11.76 (7.524), 13.56 (6.531), 17.68 (5.017), 18.63 (4.764), 20.15 (4.407), 22.08 (4.026), wherein the purity of the ultrapure Form I of the compound is from about 99.70 area % to about 99.999 area % by IPC-HPLC, the method comprising
(a) mixing Form II of the compound with water to prepare a solution of Form II of the compound;
(b) heating the solution of Form II to about 30-35° C. and cooling to room temperature to produce a precipitate; and
(c) isolating and washing the precipitate to give ultrapure Form I of compound (R)-2-[2-amino-3-(indol-3-yl)propionylamino]-2-methylpropionic acid;
(d) optionally drying the precipitate at about 45-50° C.
wherein the purity of the ultrapure Form I of the compound is from about 99.70 area % to about 99.999 area % by IPC-HPLC.