Rosuvastatin EP Impurity K Calcium Salt (E-isomer) CAS 2290571-51-4 (free acid)

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.2290571-51-4 (free acid)
Molecular Formula2*C22H25FN3O5S
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Rosuvastatin EP Impurity K Calcium Salt (E-isomer) CAS 2290571-51-4 (free acid) chemical structure

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Rosuvastatin EP Impurity K Calcium Salt (E-isomer).

Rosuvastatin EP Impurity K Calcium Salt (E-isomer) (CAS 2290571-51-4 (free acid)) is a certified pharmaceutical impurity reference standard with the molecular formula C22H25FN3O5SCa and a molecular weight of 502.59 g/mol.

Rosuvastatin EP Impurity K Calcium Salt (E-isomer) (C22H25FN3O5SCa) contains a flavonoid core, an amide group, a sulfone group, a hydroxyl group, an ether linkage, fluorine substitution. It is notably hygroscopic, halogen substitution raises its density and boiling point, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

This reference standard supports related-substances testing and method development in line with ICH Q3A/Q3B guidance on impurity control, and is suitable for system suitability testing and forced-degradation studies.

As a certified reference material (CRM), Rosuvastatin EP Impurity K Calcium Salt (E-isomer) meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

Physical & Chemical Properties

Molecular Formula2*C22H25FN3O5S Ca
Molecular Weight502.59 g/mol
Purity>95%
StorageStore in a cool place (≤25°C), protect from light, keep sealed and dry
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)11.5
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentF-containing
Nitrogen Atoms3
Sulfur Atoms1

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