Itraconazole Impurity 47 CAS CATO-C4X-149747

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-149747
Molecular Formula2*C34H34Cl2N8O4
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Itraconazole Impurity 47 CAS CATO-C4X-149747 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 47.

CATO supplies Itraconazole Impurity 47 (CAS CATO-C4X-149747), a pharmacopoeial impurity reference standard (molecular formula C34H34Cl2N8O4, MW 689.60 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Itraconazole Impurity 47 (C34H34Cl2N8O4) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 21.0, corresponding to approximately 21 ring(s) or double-bond equivalent(s). With a molecular weight of 689.60 g/mol, it falls into the high-molecular-weight range. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

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 manufactures Itraconazole Impurity 47 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 Formula2*C34H34Cl2N8O4
Molecular Weight689.60 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)21.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentCl-containing
Nitrogen Atoms8

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