Rosuvastatin (6S)-Lactone Impurity

Rosuvastatin (6S)-Lactone Impurity product with CAS: 854898-47-8 is also known as N-[(6S)-8-Fluoro-5,6-dihydro-4-(1-methylethyl)-6-[(2S,4R)-tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl]benzo[h]quinazolin-2-yl]-N-methylmethane sulfonamide. 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 (6S)-Lactone Impurity is generally used for Quality Control (QC), Quality Assurance (QA) during commercial production of Rosuvastatin and its related formulations. Moreover, N-[(6S)-8-Fluoro-5,6-dihydro-4-(1-methylethyl)-6-[(2S,4R)-tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl]benzo[h]quinazolin-2-yl]-N-methylmethane sulfonamide is also used in the process of Abbreviated New Drug Application (ANDA) filing to FDA and toxicity study of respective drug formulation.