Nalmefene Impurity 5 CAS CATO-C4X-12685

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-12685
Molecular FormulaC21H25NO3
Molecular Weight339.43 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Nalmefene Impurity 5 CAS CATO-C4X-12685 chemical structure

Description

The molecular framework of Nalmefene Impurity 5 (C21H25NO3) is characterized by a steroid core, an amide group, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by its high hydrophobicity (logP), which provides a practical basis for HPLC-UV/DAD or LC-MS method development. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.

As a process- or degradation-related impurity, Nalmefene Impurity 5 (CAS CATO-C4X-12685, C21H25NO3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

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), Nalmefene Impurity 5 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 FormulaC21H25NO3
Molecular Weight339.43 g/mol
AppearancePale yellow to yellow crystalline powder
Purity97%+
StorageStore at 2-8°C, protect from light, keep sealed and dry
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)10.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms1

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