Rosuvastatin FP Impurity B; Rosuvastatin EP Impurity H (Calcium salt)

Rosuvastatin FP Impurity B; Rosuvastatin EP Impurity H (Calcium salt) product with CAS: 1335110-44-5 is also known as (3R,5RS)-5-[8-Fluoro-4-isopropyl-2-(N-methylmethylsulfonamido)-5,6-dihydrobenzo[h]quinazolin-6-yl]-3,5-dihydroxypentanoicacid calcium 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. Rosuvastatin FP Impurity B; Rosuvastatin EP Impurity H (Calcium salt) is generally used for Quality Control (QC), Quality Assurance (QA) during commercial production of Rosuvastatin and its related formulations. Moreover, (3R,5RS)-5-[8-Fluoro-4-isopropyl-2-(N-methylmethylsulfonamido)-5,6-dihydrobenzo[h]quinazolin-6-yl]-3,5-dihydroxypentanoicacid calcium salt is also used in the process of Abbreviated New Drug Application (ANDA) filing to FDA and toxicity study of respective drug formulation.