Rosuvastatin EP Impurity B(Calcium Salt) CAS CATO-C4X-11692

Purity >90%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-11692
Molecular Formula2*C22H27FN3O6S
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Rosuvastatin EP Impurity B(Calcium Salt) CAS CATO-C4X-11692 chemical structure

Description

The occurrence of Rosuvastatin EP Impurity B(Calcium Salt) is closely related to a flavonoid core, an amide group, a sulfone group, a hydroxyl group, an ether linkage, fluorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

As a process- or degradation-related impurity, Rosuvastatin EP Impurity B(Calcium Salt) (CAS CATO-C4X-11692, C22H27FN3O6SCa) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Structurally, Rosuvastatin EP Impurity B(Calcium Salt) (C22H27FN3O6SCa) contains a flavonoid core, an amide group, a sulfone group, a hydroxyl group, an ether linkage, fluorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 10.5, corresponding to approximately 10 ring(s) or double-bond equivalent(s). With a molecular weight of 520.61 g/mol, it falls into the moderately-high-molecular-weight range. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

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.

CATO manufactures Rosuvastatin EP Impurity B(Calcium Salt) under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.

Physical & Chemical Properties

Molecular Formula2*C22H27FN3O6S Ca
Molecular Weight520.61 g/mol
Purity>90%
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)10.5
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentF-containing
Nitrogen Atoms3
Sulfur Atoms1

Related Rosuvastatin Standards

Recommended Standards

Why CATO?