Description

Rosuvastatin (6S)-Anhydro Lactone Impurity  product with CAS: 2514963-93-8 is also known as N-((S)-8-Fluoro-4-isopropyl-6-((S)-6-oxo-3,6-dihydro-2H-pyran-2-yl)-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 (6S)-Anhydro Lactone Impurity  is generally used for Quality Control (QC), Quality Assurance (QA) during commercial production of Rosuvastatin and its related formulations. Moreover, N-((S)-8-Fluoro-4-isopropyl-6-((S)-6-oxo-3,6-dihydro-2H-pyran-2-yl)-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.

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