Benidipine Impurity 46 CAS 40034-60-4

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.40034-60-4
Molecular FormulaC13H12N2O2
Molecular Weight228.25 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Benidipine Impurity 46 CAS 40034-60-4 chemical structure

Description

Benidipine Impurity 46 (CAS 40034-60-4) is a certified pharmaceutical impurity reference standard with the molecular formula C13H12N2O2 and a molecular weight of 228.25 g/mol.

Owing to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, Benidipine Impurity 46 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 228.25 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.

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 FormulaC13H12N2O2
Molecular Weight228.25 g/mol
AppearancePale yellow to yellow crystalline powder
Purity97%+
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)9.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1968
Nitrogen Atoms2

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