Donepezil Impurity 75 CAS CATO-C4X-103975

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-103975
Molecular FormulaC20H25NO
Molecular Weight295.42 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Donepezil Impurity 75 CAS CATO-C4X-103975 chemical structure

Description

As a certified reference material (CRM), Donepezil Impurity 75 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.

As a process- or degradation-related impurity, Donepezil Impurity 75 (CAS CATO-C4X-103975, C20H25NO) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Donepezil Impurity 75 (C20H25NO) contains a steroid core, an amide group, a hydroxyl group, an ether linkage. Its high carbon-to-hydrogen ratio confers good lipid solubility; these physicochemical properties determine the optimal preparation and storage of its standard solutions. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

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 FormulaC20H25NO
Molecular Weight295.42 g/mol
AppearancePale yellow to yellow crystalline powder
Purity≥95%
StorageStore at 2-8°C, protect from light
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
StabilityLight-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)9.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms1

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