Ketoconazole EP Impurity E CAS 134071-44-6

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.134071-44-6
Molecular FormulaC21H20Cl2N2O5S
Molecular Weight483.36 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Ketoconazole EP Impurity E CAS 134071-44-6 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 Ketoconazole EP Impurity E.

CATO supplies Ketoconazole EP Impurity E (CAS 134071-44-6), a pharmacopoeial impurity reference standard (molecular formula C21H20Cl2N2O5S, MW 483.36 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C21H20Cl2N2O5S, Ketoconazole EP Impurity E contains a flavonoid core, an amide group, a sulfone group, a hydroxyl group, an ether linkage, chlorine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 483.36 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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.

CATO manufactures Ketoconazole EP Impurity E 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 FormulaC21H20Cl2N2O5S
Molecular Weight483.36 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)12.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1995
Halogen ContentCl-containing
Nitrogen Atoms2
Sulfur Atoms1

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