Fluvastatin Impurity 15 Sodium Salt CAS CATO-C4X-165115

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-165115
Molecular FormulaC24H23FNO3
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Fluvastatin Impurity 15 Sodium Salt CAS CATO-C4X-165115 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 Fluvastatin Impurity 15 Sodium Salt.

As a process- or degradation-related impurity, Fluvastatin Impurity 15 Sodium Salt (CAS CATO-C4X-165115, C24H23FNO3Na) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Owing to a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution, Fluvastatin Impurity 15 Sodium Salt is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 415.44 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.

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 FormulaC24H23FNO3 Na
Molecular Weight415.44 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
Purity97%+
StorageStore at room temperature, protect from light, keep sealed and dry
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
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)13.5
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentF-containing
Nitrogen Atoms1

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