Clevidipine Butyrate impurity 19 CAS 253597-20-5

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.253597-20-5
Molecular FormulaC15H15Cl2NO2
Molecular Weight312.19 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Clevidipine Butyrate impurity 19 CAS 253597-20-5 chemical structure

Description

Clevidipine Butyrate impurity 19 (CAS 253597-20-5) is a certified pharmaceutical impurity reference standard with the molecular formula C15H15Cl2NO2 and a molecular weight of 312.19 g/mol.

Based on its molecular formula C15H15Cl2NO2, Clevidipine Butyrate impurity 19 contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, chlorine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 312.19 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 FormulaC15H15Cl2NO2
Molecular Weight312.19 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor, low volatility)
Purity>95%
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; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)8.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)2025
Halogen ContentCl-containing
Nitrogen Atoms1

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