Pitavastatin Calcium

Pitavastatin Calcium product with CAS: 147511-69-1 (Base); 147526-32-7 (Ca salt) is also known as (+)-Monocalcium bis{(3R,5S,6E)-7-[2-cyclopropyl-4-(4-fluorophenyl)-3-quinolyl]-3,5-dihydroxy-6-heptenoate}. This product can be used as a working standard or secondary reference standard. Additional internal validation as per respective FDA regulations/guidelines may require. Pitavastatin Calcium is generally used for Quality Control (QC), Quality Assurance (QA) during commercial production of Pitavastatin and its related formulations. Moreover, (+)-Monocalcium bis{(3R,5S,6E)-7-[2-cyclopropyl-4-(4-fluorophenyl)-3-quinolyl]-3,5-dihydroxy-6-heptenoate} is also used in the process of Abbreviated New Drug Application (ANDA) filing to FDA and toxicity study of respective drug formulation.