Rosuvastatin Ep Impurity E

By Author: Veeprhogroup
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Rosuvastatin EP Impurity E has molecular formula is C38H45F2N6O9S2 . 1/2Ca+2. Its Molecular Weight is 851.97 g/mol. The IUPAC Name of Impurity is (3R,5S,E)-7-(4-(4-fluorophenyl)-2-(2-(4-(4-fluorophenyl)-6-isopropyl-2-(Nmethylmethylsulfonamido) pyrimidin-5-yl)-2-hydroxy-N-methylethylsulfonamido)-6- isopropylpyrimidin-5-yl)-3,5-dihydroxyhept-6-enoic acid. Its Synonym is Rosuvastatin Related Compound B. It is an impurity of Rosuvastatin.

Rosuvastatin calcium is a synthetic lipid-lowering agent used for oral administration. It suppresses HMG-CoA reductase, the rate-limiting enzyme which converts HMG-CoA to mevalonate, a precursor of cholesterol. Rosuvastatin calcium (RSC) is a synthetic lipid-lowering agent for oral administration. Rosuvastatin is also a unique member of the class of statins due to its high hydrophilicity which increases hepatic uptake at the site of action, low bioavailability, and minimal metabolism via the Cytochrome P450 system. Rosuvastatin is used for the treatment of hyperlipidemia and is an inhibitor of 3-hydroxy-3-methylglutaryl coenzyme (HMG-CoA) reductase. (3R,5R)-Rosuvastatin ...
... is an enantiomer of Rosuvastatin used for treatment, prevention and combination therapy of lipid-related disorders
It is necessary to develop such a method which can detect and separate all the possible degradant and process impurities.
This product can be used as a working standard or secondary reference standard. Rosuvastatin Related compound B is generally used for Quality Control (QC), Quality Assurance (QA) during commercial production of Rosuvastatin and its related formulations.

References
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