Fluvastatin EP Impurity C(Sodium Salt) CAS 2451176-31-9 (free acid)

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.2451176-31-9 (free acid)
Molecular FormulaC23H23FNNaO4
Molecular Weight419.42 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Fluvastatin EP Impurity C(Sodium Salt) CAS 2451176-31-9 (free acid) chemical structure

Description

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

Fluvastatin EP Impurity C(Sodium Salt) (CAS 2451176-31-9 (free acid)) is a certified pharmaceutical impurity reference standard with the molecular formula C23H23FNNaO4 and a molecular weight of 419.42 g/mol.

Based on its molecular formula C23H23FNNaO4, Fluvastatin EP Impurity C(Sodium Salt) contains a flavonoid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 419.42 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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.

As a certified reference material (CRM), Fluvastatin EP Impurity C(Sodium Salt) meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

Physical & Chemical Properties

Molecular FormulaC23H23FNNaO4
Molecular Weight419.42 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
Purity>95%
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
Halogen ContentF-containing
Nitrogen Atoms1

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