Rosuvastatin Impurity SA12159

Rosuvastatin Impurity SA12159 product with CAS: NA is also known as N-(8-fluoro-6-((2S,4R)-4-hydroxy-6-oxotetrahydro-2H-pyran-2-yl)-4-isopropyl-5,6-dihydrobenzo[h]quinazolin-2-yl)-N-methylmethanesulfonamide. 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 Impurity SA12159 is generally used for Quality Control (QC), Quality Assurance (QA) during commercial production of Rosuvastatin and its related formulations. Moreover, N-(8-fluoro-6-((2S,4R)-4-hydroxy-6-oxotetrahydro-2H-pyran-2-yl)-4-isopropyl-5,6-dihydrobenzo[h]quinazolin-2-yl)-N-methylmethanesulfonamide is also used in the process of Abbreviated New Drug Application (ANDA) filing to FDA and toxicity study of respective drug formulation.