Rosuvastatin FP Impurity B; Rosuvastatin EP Impurity H (Calcium salt)
Price : $350 – $1,350
| CAS No. | : 1335110-44-5 |
| Mol F. | : C22H27FN3O6S•1/2Ca |
| Mol W. | : 500.61 |
| Cat No. | : SA12189 |
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Description
| Product Name | Rosuvastatin FP Impurity B; Rosuvastatin EP Impurity H (Calcium salt) |
| Synonyms | (3R,5RS)-5-[8-Fluoro-4-isopropyl-2-(N-methylmethylsulfonamido)-5,6-dihydrobenzo[h]quinazolin-6-yl]-3,5-dihydroxypentanoicacid calcium salt |
| Related API | Rosuvastatin |
| Category | Impurities |
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.
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