Ketoconazole impurity 31 CAS CATO-C4X-147231

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-147231
Molecular FormulaC11H11BrCl2O3
Molecular Weight342.01 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Ketoconazole impurity 31 CAS CATO-C4X-147231 chemical structure

Description

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.

CATO supplies Ketoconazole impurity 31 (CAS CATO-C4X-147231), a pharmacopoeial impurity reference standard (molecular formula C11H11BrCl2O3, MW 342.01 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C11H11BrCl2O3, Ketoconazole impurity 31 contains a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine/bromine substitution, an aromatic ring system; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 342.01 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.

CATO manufactures Ketoconazole impurity 31 under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.

Physical & Chemical Properties

Molecular FormulaC11H11BrCl2O3
Molecular Weight342.01 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor, low volatility)
Purity97%+
StorageStore in a cool place (≤25°C), keep sealed and dry
Solubility (reference)Soluble in methanol, ethanol, DMSO
StabilityMay oxidize slowly on prolonged air exposure; Hygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)5.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentCl/Br-containing

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