Donepezil Impurity 19 CAS CATO-C4X-103919

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-103919
Molecular FormulaC17H25NO3
Molecular Weight291.39 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Donepezil Impurity 19 CAS CATO-C4X-103919 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 Donepezil Impurity 19.

Donepezil Impurity 19 (CAS CATO-C4X-103919) is a certified pharmaceutical impurity reference standard with the molecular formula C17H25NO3 and a molecular weight of 291.39 g/mol.

Owing to a steroid core, an amide group, a hydroxyl group, an ether linkage, Donepezil Impurity 19 is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 291.39 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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.

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 FormulaC17H25NO3
Molecular Weight291.39 g/mol
AppearanceOff-white to pale yellow crystalline powder
Purity97%+
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
Degree of Unsaturation (DBE)6.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms1

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