Fluvastatin EP Impurity A Sodium Salt(and enantiomer) CAS 93957-58-5

Purity >90%In StockPharmacopoeial Impurity Standards
CAS No.93957-58-5
Molecular Formula2*C24H25FNO4
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Fluvastatin EP Impurity A Sodium Salt(and enantiomer) CAS 93957-58-5 chemical structure

Description

Compared with other compounds in its class, the molecular weight of 433.45 g/mol gives Fluvastatin EP Impurity A Sodium Salt(and enantiomer) distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

Fluvastatin EP Impurity A Sodium Salt(and enantiomer) (CAS 93957-58-5) is a certified pharmaceutical impurity reference standard with the molecular formula C24H25FNO4Na and a molecular weight of 433.45 g/mol.

The molecular framework of Fluvastatin EP Impurity A Sodium Salt(and enantiomer) (C24H25FNO4Na) is characterized by a flavonoid core, an amide 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. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

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*C24H25FNO4 2*Na
Molecular Weight433.45 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
Purity>90%
StorageStore at room temperature, protect from light, keep sealed and dry
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)12.5
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1983
Halogen ContentF-containing
Nitrogen Atoms1

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