Rosuvastatin acetonide N,N’-dimethy amide

Rosuvastatin N,N’-dimethy amide product with CAS: NA is also known as 2-((4S,6R)-6-((E)-2-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)vinyl)-2,2-dimethyl-1,3-dioxan-4-yl)-N,N-dimethylacetamide. 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 N,N’-dimethy amide is generally used for Quality Control (QC), Quality Assurance (QA) during commercial production of Rosuvastatin and its related formulations. Moreover, 2-((4S,6R)-6-((E)-2-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)vinyl)-2,2-dimethyl-1,3-dioxan-4-yl)-N,N-dimethylacetamide is also used in the process of Abbreviated New Drug Application (ANDA) filing to FDA and toxicity study of respective drug formulation.