Description

(3S,5R,7R)-Rosuvstatin Impurity I (EP) product with CAS: NA is also known as (3S,5R)-5-((R)-8-fluoro-4-isopropyl-2-(N-methylmethylsulfonamido)-5,6-dihydrobenzo[h]quinazolin-6-yl)-3,5-dihydroxypentanoate Sodium Salt. This product can be used as a working standard or secondary reference standard. Additional internal validation as per respective FDA regulations/guidelines may require. (3S,5R,7R)-Rosuvstatin Impurity I (EP) is generally used for Quality Control (QC), Quality Assurance (QA) during commercial production of Rosuvastatin and its related formulations. Moreover, (3S,5R)-5-((R)-8-fluoro-4-isopropyl-2-(N-methylmethylsulfonamido)-5,6-dihydrobenzo[h]quinazolin-6-yl)-3,5-dihydroxypentanoate Sodium Salt 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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