NOVEL CRYSTALLINE FORMS OF PITAVASTATIN CALCIUM

摘要

PROBLEM TO BE SOLVED: To provide novel crystalline forms A of pitavastatin calcium, and pharmaceutical compositions containing the same.SOLUTION: A crystalline polymorph A of (3R,5S)-7-[2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl]-3,5-dihydroxy-6(E)-heptenoic acid hemicalcium salt exhibits a characteristic X-ray powder diffraction pattern with characteristic peaks expressed in 2θat 5.0±0.2°, 6.8±0.2°, 9.1±0.2°, 13.7±0.2°, 20.8±0.2° and 24.2±0.2° and has a water content of 3-15% measured by thermogravimetry coupled with FT-IR spectroscopy.