Rosuvastatin EP Impurity E (Calcium Salt); Rosuvastatin Related compound B

Rosuvastatin EP Impurity E (Calcium Salt); Rosuvastatin Related compound B product with CAS: 2226413-61-0 (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]-2-hydroxy-ethylsulfonyl)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 E (Calcium Salt); Rosuvastatin Related compound B 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]-2-hydroxy-ethylsulfonyl)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.