Rosuvastatin EP Impurity A (Sodium salt)

Rosuvastatin EP Impurity A (Sodium salt) is chemically Sodium (3R,5S,6E)-7-[2-(2,N-dimethyl-2-hydroxypropane-1-sulfonamido)-4-(4-fluorophenyl)-6-(propan-2-yl)pyrimidin-5-yl]-3,5-dihydroxyhept-6-enoate (as per EP)Sodium (3R,5S,E)-7-{4-(4-fluorophenyl)-2-[(2-hydroxy-N,2-dimethylpropyl)sulfonamide]-6-isopropylpyrimidin-5-yl}-3,5-dihydroxyhept-6-enoate salt (as per USP). It is also known as Rosuvastatin USP Related Compound A. Rosuvastatin EP Impurity A (Sodium salt) is supplied with detailed characterization data compliant with regulatory guideline. Rosuvastatin EP Impurity A (Sodium salt) can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Rosuvastatin.

The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. SynZeal products are for analytical purpose only and not for human use.