Rosuvastatin EP Impurity J (Calcium Salt)

Rosuvastatin EP Impurity J (Calcium Salt) product with CAS: 2226413-62-1 (free acid) is also known as (3R,5S,6E)-7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl (2-[4-(4-fluorophenyl)-6-(1-methylethyl)-2-(methyl (methylsulfonyl)amino]-5-pyrimidinyl]-ethenylsulfonyl)amino)-5-pyrimidinyl]-3,5-dihydroxy-6-heptenoic acid calcium salt. This product can be used as a working standard or secondary reference standard. Additional internal validation as per respective FDA regulations/guidelines may require. Rosuvastatin EP Impurity J (Calcium Salt) is generally used for Quality Control (QC), Quality Assurance (QA) during commercial production of Rosuvastatin and its related formulations. Moreover, (3R,5S,6E)-7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl (2-[4-(4-fluorophenyl)-6-(1-methylethyl)-2-(methyl (methylsulfonyl)amino]-5-pyrimidinyl]-ethenylsulfonyl)amino)-5-pyrimidinyl]-3,5-dihydroxy-6-heptenoic acid calcium salt is also used in the process of Abbreviated New Drug Application (ANDA) filing to FDA and toxicity study of respective drug formulation.