Itraconazole Impurity 15 CAS 2508172-07-2

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.2508172-07-2
Molecular Formula2*C34H36Cl2N8O4
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Itraconazole Impurity 15 CAS 2508172-07-2 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 15.

CATO supplies Itraconazole Impurity 15 (CAS 2508172-07-2), a pharmacopoeial impurity reference standard (molecular formula C34H36Cl2N8O4, MW 691.61 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 15 is typically pale yellow to yellow amorphous powder. Its solid-state physicochemical attributes — including a molecular weight of 691.61 g/mol — guide the selection of appropriate sample preparation and analytical techniques. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

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 Impurity 15 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*C34H36Cl2N8O4
Molecular Weight691.61 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)20.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)2000
Halogen ContentCl-containing
Nitrogen Atoms8

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