Rosuvastatin D-5 Enatiomer Impurity

Rosuvastatin D-5 Enatiomer Impurity product with CAS: 2375865-91-9 is also known as Tert-butyl 2-((4S,6R)-6-(acetoxymethyl)-2,2-dimethyl-1,3-dioxan-4-yl)acetate. 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 D-5 Enatiomer Impurity is generally used for Quality Control (QC), Quality Assurance (QA) during commercial production of Rosuvastatin and its related formulations. Moreover, Tert-butyl 2-((4S,6R)-6-(acetoxymethyl)-2,2-dimethyl-1,3-dioxan-4-yl)acetate is also used in the process of Abbreviated New Drug Application (ANDA) filing to FDA and toxicity study of respective drug formulation.