Itraconazole Impurity 85 CAS CATO-C4X-149785

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-149785
Molecular Formula2*C35H38Cl2N8O6
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Itraconazole Impurity 85 CAS CATO-C4X-149785 chemical structure

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Itraconazole Impurity 85.

CATO supplies Itraconazole Impurity 85 (CAS CATO-C4X-149785), a pharmacopoeial impurity reference standard (molecular formula C35H38Cl2N8O6, MW 737.64 g/mol) used for the identification and quantification of trace impurities in APIs.

Owing to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, chlorine substitution, Itraconazole Impurity 85 is typically pale yellow to yellow amorphous powder. Its solid-state physicochemical attributes — including a molecular weight of 737.64 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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).

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 Formula2*C35H38Cl2N8O6
Molecular Weight737.64 g/mol
Purity≥95%
StorageStore in a cool place (≤25°C), protect from light, keep sealed and dry
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)20.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentCl-containing
Nitrogen Atoms8

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