Itraconazole EP Impurity G(Mixture of Enantiomers) CAS CATO-C4X-14977

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-14977
Molecular Formula2*C44H41Cl4N11O6
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Itraconazole EP Impurity G(Mixture of Enantiomers) CAS CATO-C4X-14977 chemical structure

Description

CATO supplies Itraconazole EP Impurity G(Mixture of Enantiomers) (CAS CATO-C4X-14977), a pharmacopoeial impurity reference standard (molecular formula C44H41Cl4N11O6, MW 961.68 g/mol) used for the identification and quantification of trace impurities in APIs.

Itraconazole EP Impurity G(Mixture of Enantiomers) (C44H41Cl4N11O6) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. It is notably hygroscopic, halogen substitution raises its density and boiling point, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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.

As a certified reference material (CRM), Itraconazole EP Impurity G(Mixture of Enantiomers) 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.

Physical & Chemical Properties

Molecular Formula2*C44H41Cl4N11O6
Molecular Weight961.68 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)28.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentCl-containing
Nitrogen Atoms11

Related Itraconazole Standards

Recommended Standards

Why CATO?