Rosuvastatin Impurity 158 CAS CATO-C4X-1169158

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-1169158
Molecular FormulaC22H29FN3NaO6S
Molecular Weight505.54 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Rosuvastatin Impurity 158 CAS CATO-C4X-1169158 chemical structure

Description

Rosuvastatin Impurity 158 (CAS CATO-C4X-1169158) is a certified pharmaceutical impurity reference standard with the molecular formula C22H29FN3NaO6S and a molecular weight of 505.54 g/mol.

The molecular framework of Rosuvastatin Impurity 158 (C22H29FN3NaO6S) 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. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

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 FormulaC22H29FN3NaO6S
Molecular Weight505.54 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)9.5
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentF-containing
Nitrogen Atoms3
Sulfur Atoms1

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