Fluconazole EP Impurity G (R-Isomer) CAS CATO-C4X-101965

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-101965
Molecular FormulaC11H9F2N3O
Molecular Weight237.21 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Fluconazole EP Impurity G (R-Isomer) CAS CATO-C4X-101965 chemical structure

Description

As a certified reference material (CRM), Fluconazole EP Impurity G (R-Isomer) meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

As a process- or degradation-related impurity, Fluconazole EP Impurity G (R-Isomer) (CAS CATO-C4X-101965, C11H9F2N3O) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Structurally, Fluconazole EP Impurity G (R-Isomer) (C11H9F2N3O) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 8.0, corresponding to approximately 8 ring(s) or double-bond equivalent(s). With a molecular weight of 237.21 g/mol, it falls into the medium-molecular-weight range. 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 FormulaC11H9F2N3O
Molecular Weight237.21 g/mol
Purity≥95%
StorageStore at 2-8°C, protect from light, keep tightly closed to prevent evaporation
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)8.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentF-containing
Nitrogen Atoms3

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