Verapamil Impurity 50 CAS CATO-C4X-177850

Purity 95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-177850
Molecular FormulaC13H20ClNO2
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Verapamil Impurity 50 CAS CATO-C4X-177850 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 Verapamil Impurity 50.

Verapamil Impurity 50 (CAS CATO-C4X-177850) is a certified pharmaceutical impurity reference standard with the molecular formula C13H20ClNO2HCl and a molecular weight of 294.22 g/mol.

Structurally, Verapamil Impurity 50 (C13H20ClNO2HCl) contains an amide group, a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 3.0, corresponding to approximately 3 ring(s) or double-bond equivalent(s). With a molecular weight of 294.22 g/mol, it falls into the medium-molecular-weight range. 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 FormulaC13H20ClNO2 HCl
Molecular Weight294.22 g/mol
AppearanceWhite to pale yellow crystalline powder. (slight halide-like odor, low volatility)
Purity95%
StorageStore at 2-8°C, protect from light, keep tightly closed to prevent evaporation
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)3.0
UV AbsorptionUV-absorbing
Halogen ContentCl-containing
Nitrogen Atoms1

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