Ensifentrine impurity CAS 4359-64-2

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.4359-64-2
Molecular FormulaC18H24N2
Molecular Weight268.40 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Ensifentrine impurity CAS 4359-64-2 chemical structure

Description

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.

Ensifentrine impurity (CAS 4359-64-2) is a certified pharmaceutical impurity reference standard with the molecular formula C18H24N2 and a molecular weight of 268.40 g/mol.

Based on its molecular formula C18H24N2, Ensifentrine impurity contains a nitrogen-containing heterocyclic scaffold, a nitrile group; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 268.40 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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.

Physical & Chemical Properties

Molecular FormulaC18H24N2
Molecular Weight268.40 g/mol
Purity97%+
StorageStore at 2-8°C, protect from light
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityLight-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)8.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1958
Nitrogen Atoms2

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