Rosuvastatin EP Impurity D; Rosuvastatin Lactone

Rosuvastatin EP Impurity D; Rosuvastatin Lactone product with CAS: 503610-43-3 is also known as N-[4-(4-Fluorophenyl)-6-(1-methylethyl)-5-[(1E)-2-[(2S,4R)-tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl]ethenyl]-2-pyrimidinyl]-N-methyl-methanesulfonamide. 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 D; Rosuvastatin Lactone is generally used for Quality Control (QC), Quality Assurance (QA) during commercial production of Rosuvastatin and its related formulations. Moreover, N-[4-(4-Fluorophenyl)-6-(1-methylethyl)-5-[(1E)-2-[(2S,4R)-tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl]ethenyl]-2-pyrimidinyl]-N-methyl-methanesulfonamide is also used in the process of Abbreviated New Drug Application (ANDA) filing to FDA and toxicity study of respective drug formulation.