Nifedipine Impurity 36 CAS CATO-C4X-141036

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-141036
Molecular FormulaC15H15NO5
Molecular Weight289.28 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Nifedipine Impurity 36 CAS CATO-C4X-141036 chemical structure

Description

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.

CATO supplies Nifedipine Impurity 36 (CAS CATO-C4X-141036), a pharmacopoeial impurity reference standard (molecular formula C15H15NO5, MW 289.28 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C15H15NO5, Nifedipine Impurity 36 contains a flavonoid core, an amide group, a hydroxyl group, an ether linkage; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 289.28 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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).

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 FormulaC15H15NO5
Molecular Weight289.28 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 methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)9.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms1

Related Nifedipine Standards

Recommended Standards

Why CATO?