Clevidipine Impurity 24-13C-d3 CAS CATO-C4X-101524

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-101524
Molecular FormulaC15[13C]H12D3Cl2NO4
Molecular Weight360.21 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Clevidipine Impurity 24-13C-d3 CAS CATO-C4X-101524 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 Clevidipine Impurity 24-13C-d3.

Clevidipine Impurity 24-13C-d3 (CAS CATO-C4X-101524) is a certified pharmaceutical impurity reference standard with the molecular formula C15[13C]H12D3Cl2NO4 and a molecular weight of 360.21 g/mol.

The molecular framework of Clevidipine Impurity 24-13C-d3 (C15[13C]H12D3Cl2NO4) is characterized by deuterium isotope labeling, a flavonoid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

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 FormulaC15[13C]H12D3Cl2NO4
Molecular Weight360.21 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor, low volatility)
Purity>95%
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; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)10.5
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentCl-containing
Nitrogen Atoms1

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