Rosuvastatin EP Impurity L; 6,7-Dihydro Rosuvastatin Calcium Salt

Rosuvastatin EP Impurity L; 6,7-Dihydro Rosuvastatin Calcium Salt product with CAS: 1347362-67-7 is also known as (βR,δR)-4-(4-Fluorophenyl)-β,δ-dihydroxy-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidineheptanoic 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 L; 6,7-Dihydro Rosuvastatin Calcium Salt is generally used for Quality Control (QC), Quality Assurance (QA) during commercial production of Rosuvastatin and its related formulations. Moreover, (βR,δR)-4-(4-Fluorophenyl)-β,δ-dihydroxy-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidineheptanoic 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.