6-Heptenoic acid, 7-[2-cyclopropyl-4-(4-fluorophenyl)-3-quinolinyl]-3,5-dihydroxy-, (3R,5S,6E)-, calcium salt (2:1);
Calcium (3R,5S,6E)-7-[2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl]-3,5-dihydroxyhept-6-enoate [147526-32-7]
BRIEFING
Pitavastatin Calcium. Because there is no existing USP monograph for this drug substance, a new monograph based on validated methods of analysis is proposed.
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The liquid chromatographic procedures in the Assay and the test for Organic Impurities are validated using the Ascentis Express C18 brand of column with L1 packing. The typical retention time for pitavastatin is about 9 min in the Assay and about 19 min in the test for Organic Impurities.
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The liquid chromatographic procedure in the test of Limit of Pitavastatin Enantiomer is validated using the Chiralpak IA brand of column with L99 packing. The typical retention time of pitavastatin is about 35 min.
Description and solubility information: White to pale yellow powder. Sparingly soluble in pyridine; practically insoluble in water.
(SM2: W. Yang)
Case ID—SUB-800