Rosuvastatin EP Impurity C(Calcium Salt) CAS 1422514-05-3

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.1422514-05-3
Molecular Formula2*C22H25FN3O6S
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Rosuvastatin EP Impurity C(Calcium Salt) CAS 1422514-05-3 chemical structure

Description

The occurrence of Rosuvastatin EP Impurity C(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.

Rosuvastatin EP Impurity C(Calcium Salt) (CAS 1422514-05-3) is a certified pharmaceutical impurity reference standard with the molecular formula C22H25FN3O6SCa and a molecular weight of 518.59 g/mol.

The molecular framework of Rosuvastatin EP Impurity C(Calcium Salt) (C22H25FN3O6SCa) is characterized by a flavonoid core, an amide group, a sulfone group, a hydroxyl group, an ether linkage, fluorine substitution. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. 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.

The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.

Physical & Chemical Properties

Molecular Formula2*C22H25FN3O6S Ca
Molecular Weight518.59 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
CAS Registry Year (est.)1991
Halogen ContentF-containing
Nitrogen Atoms3
Sulfur Atoms1

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