Nicardipine Impurity 36 CAS 115972-93-5

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.115972-93-5
Molecular FormulaC12H19NO2
Molecular Weight209.28 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Nicardipine Impurity 36 CAS 115972-93-5 chemical structure

Description

CATO supplies Nicardipine Impurity 36 (CAS 115972-93-5), a pharmacopoeial impurity reference standard (molecular formula C12H19NO2, MW 209.28 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C12H19NO2, Nicardipine Impurity 36 contains an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 209.28 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

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 FormulaC12H19NO2
Molecular Weight209.28 g/mol
AppearanceOff-white to pale yellow crystalline powder
Purity97%+
StorageStore at 2-8°C, protect from light
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)4.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1990
Nitrogen Atoms1

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