Nicardipine Impurity N12 CAS CATO-C4X-29432

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-29432
Molecular FormulaC16H19NO
Molecular Weight241.33 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Nicardipine Impurity N12 CAS CATO-C4X-29432 chemical structure

Description

As a certified reference material (CRM), Nicardipine Impurity N12 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, Nicardipine Impurity N12 (CAS CATO-C4X-29432, C16H19NO) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Owing to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, Nicardipine Impurity N12 is typically pale yellow to yellow low-melting solid. Its solid-state physicochemical attributes — including a molecular weight of 241.33 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 FormulaC16H19NO
Molecular Weight241.33 g/mol
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)8.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms1

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