Fluconazole Impurity 11 CAS 51336-94-8

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.51336-94-8
Molecular FormulaC8H5ClF2O
Molecular Weight190.57 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Fluconazole Impurity 11 CAS 51336-94-8 chemical structure

Description

Compared with other compounds in its class, the molecular weight of 190.57 g/mol gives Fluconazole Impurity 11 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

Fluconazole Impurity 11 (CAS 51336-94-8) is a certified pharmaceutical impurity reference standard with the molecular formula C8H5ClF2O and a molecular weight of 190.57 g/mol.

Owing to a hydroxyl group, an ether linkage, fluorine/chlorine substitution, an aromatic ring system, Fluconazole Impurity 11 is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 190.57 g/mol — guide the selection of appropriate sample preparation and analytical techniques. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

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 FormulaC8H5ClF2O
Molecular Weight190.57 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor, low volatility)
Purity>95%
StorageStore at 2-8°C, keep tightly closed to prevent evaporation
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityMay oxidize slowly on prolonged air exposure
Degree of Unsaturation (DBE)5.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1971
Halogen ContentF/Cl-containing

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