Fluconazole EP Impurity H (R-Isomer) CAS CATO-C4X-101966

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-101966
Molecular FormulaC11H10BrF2N3O
Molecular Weight318.12 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Fluconazole EP Impurity H (R-Isomer) CAS CATO-C4X-101966 chemical structure

Description

The occurrence of Fluconazole EP Impurity H (R-Isomer) is closely related to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine/bromine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

CATO supplies Fluconazole EP Impurity H (R-Isomer) (CAS CATO-C4X-101966), a pharmacopoeial impurity reference standard (molecular formula C11H10BrF2N3O, MW 318.12 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C11H10BrF2N3O, Fluconazole EP Impurity H (R-Isomer) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine/bromine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 318.12 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).

Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.

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 FormulaC11H10BrF2N3O
Molecular Weight318.12 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor, low volatility)
Purity≥95%
StorageStore at 2-8°C, protect from light
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)7.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentF/Br-containing
Nitrogen Atoms3

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