Crystalline ammonium salts of rosuvastatin
Provided are alkyl ammonium crystalline salts of rosuvastatin that provide for purification of rosuvastatin and its pharmaceutically acceptable salts.
1. A crystalline form of rosuvastatin isopropylammonium salt having an X-ray powder diffraction pattern with peaks at 6.2, 18.8, 19.3, 20.6 and 22.3±0.2 deg. 2-theta.
2. The crystalline form of claim 1 , further having peaks at 6.0, 10.2, 10.6, 13.4, 15.6, 16.6, 18.2, 27.3 and 28.8±0.2 deg. 2-theta.
3. The crystalline form of claim 1 , wherein the crystalline form has an X-ray powder diffraction pattern substantially as depicted in FIG. 1 .
4. A process for preparing the crystalline form of claim 1 , said process comprising combining a solution of rosuvastatin acid in an organic solvent with isopropylamine to precipitate the crystalline form and recovering the crystalline form.
5. The process of claim 4 , wherein precipitation is induced by cooling the solution to a temperature of less than about 10° C.
6. The process of claim 4 , wherein the combining is at a temperature of about 20° C. to about 40° C.
7. The process of claim 6 , wherein the temperature is about 30° C.
8. The process of claim 4 , wherein the solvent is acetonitrile or ethyl acetate.
9. A process for preparing the crystalline form of claim 1 , said process comprising combining a solution of rosuvastatin acid in acetonitrile or ethyl acetate with isopropylamine followed by stirring at a temperature of about 30° C., followed by cooling to a temperature of less than about 10° C. to precipitate the crystalline form and recovering the crystalline form.