Clotrimazole EP Impurity E CAS 5162-03-8

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.5162-03-8
Molecular FormulaC13H9ClO
Molecular Weight216.66 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Clotrimazole EP Impurity E CAS 5162-03-8 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 Clotrimazole EP Impurity E.

CATO supplies Clotrimazole EP Impurity E (CAS 5162-03-8), a pharmacopoeial impurity reference standard (molecular formula C13H9ClO, MW 216.66 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C13H9ClO, Clotrimazole EP Impurity E contains a hydroxyl group, an ether linkage, chlorine substitution, an aromatic ring system; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 216.66 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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.

As a certified reference material (CRM), Clotrimazole EP Impurity E 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 FormulaC13H9ClO
Molecular Weight216.66 g/mol
Purity>95%
StorageStore at 2-8°C, protect from light, keep tightly closed to prevent evaporation
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)9.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1958
Halogen ContentCl-containing

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