Fluconazole Impurity 18 CAS 383127-79-5

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.383127-79-5
Molecular FormulaC10H12BrN
Molecular Weight226.11 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Fluconazole Impurity 18 CAS 383127-79-5 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.

Fluconazole Impurity 18 (CAS 383127-79-5) is a certified pharmaceutical impurity reference standard with the molecular formula C10H12BrN and a molecular weight of 226.11 g/mol.

Based on its molecular formula C10H12BrN, Fluconazole Impurity 18 contains a nitrogen-containing heterocyclic scaffold, a nitrile group, bromine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 226.11 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 FormulaC10H12BrN
Molecular Weight226.11 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor, faint amine-like odor)
Purity97%+
StorageStore at 2-8°C, protect from light, keep tightly closed to prevent evaporation
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)5.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)2025
Halogen ContentBr-containing
Nitrogen Atoms1

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