rac-Amorolfine Impurity 18 (Mixture of Diastereomers) CAS CATO-C4X-154218

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-154218
Molecular FormulaC21H35NO2
Molecular Weight333.51 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

rac-Amorolfine Impurity 18 (Mixture of Diastereomers) CAS CATO-C4X-154218 chemical structure

Description

Owing to a steroid core, an amide group, a hydroxyl group, an ether linkage, rac-Amorolfine Impurity 18 (Mixture of Diastereomers) is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 333.51 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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).

CATO supplies rac-Amorolfine Impurity 18 (Mixture of Diastereomers) (CAS CATO-C4X-154218), a pharmacopoeial impurity reference standard (molecular formula C21H35NO2, MW 333.51 g/mol) used for the identification and quantification of trace impurities in APIs.

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), rac-Amorolfine Impurity 18 (Mixture of Diastereomers) 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 FormulaC21H35NO2
Molecular Weight333.51 g/mol
AppearanceOff-white to pale yellow crystalline powder
Purity97%+
StorageStore at 2-8°C, protect from light
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)5.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms1

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