Felodipine Impurity 31 CAS CATO-C4X-109431

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-109431
Molecular FormulaC18H19Cl2NO4
Molecular Weight384.25 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Felodipine Impurity 31 CAS CATO-C4X-109431 chemical structure

Description

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.

CATO supplies Felodipine Impurity 31 (CAS CATO-C4X-109431), a pharmacopoeial impurity reference standard (molecular formula C18H19Cl2NO4, MW 384.25 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C18H19Cl2NO4, Felodipine Impurity 31 contains a flavonoid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 384.25 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

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 FormulaC18H19Cl2NO4
Molecular Weight384.25 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor, low volatility)
Purity97%+
StorageStore at 2-8°C, 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)9.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentCl-containing
Nitrogen Atoms1

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