Itraconazole Impurity 48 CAS CATO-C4X-149748

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-149748
Molecular FormulaC39H36Cl2N8O6
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Itraconazole Impurity 48 CAS CATO-C4X-149748 chemical structure

Description

CATO manufactures Itraconazole Impurity 48 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.

CATO supplies Itraconazole Impurity 48 (CAS CATO-C4X-149748), a pharmacopoeial impurity reference standard (molecular formula C39H36Cl2N8O6, MW 783.67 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 48 is typically pale yellow to yellow amorphous powder. Its solid-state physicochemical attributes — including a molecular weight of 783.67 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.

Physical & Chemical Properties

Molecular FormulaC39H36Cl2N8O6
Molecular Weight783.67 g/mol
Purity97%+
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)25.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentCl-containing
Nitrogen Atoms8

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