Choline fenofibrate EP Impurity E CAS 42019-08-9

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.42019-08-9
Molecular FormulaC19H19ClO4
Molecular Weight346.80 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Choline fenofibrate EP Impurity E CAS 42019-08-9 chemical structure

Description

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.

CATO supplies Choline fenofibrate EP Impurity E (CAS 42019-08-9), a pharmacopoeial impurity reference standard (molecular formula C19H19ClO4, MW 346.80 g/mol) used for the identification and quantification of trace impurities in APIs.

Owing to a flavonoid core, a hydroxyl group, an ether linkage, chlorine substitution, Choline fenofibrate EP Impurity E is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 346.80 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.

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.

Physical & Chemical Properties

Molecular FormulaC19H19ClO4
Molecular Weight346.80 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
Purity>95%
StorageStore at 2-8°C, 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)10.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1969
Halogen ContentCl-containing

Related Choline Standards

Recommended Standards

Why CATO?