Terbinafine impurity 38 CAS CATO-C4X-133838

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-133838
Molecular FormulaC21H26NO
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Terbinafine impurity 38 CAS CATO-C4X-133838 chemical structure

Description

As a certified reference material (CRM), Terbinafine impurity 38 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.

As a process- or degradation-related impurity, Terbinafine impurity 38 (CAS CATO-C4X-133838, C21H26NO) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Terbinafine impurity 38 (C21H26NO) contains a steroid core, an amide group, a hydroxyl group, an ether linkage. Its high carbon-to-hydrogen ratio confers good lipid solubility; these physicochemical properties determine the optimal preparation and storage of its standard solutions. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

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.

Physical & Chemical Properties

Molecular FormulaC21H26NO
Molecular Weight308.44 g/mol
AppearancePale yellow to yellow crystalline powder
Purity97%+
StorageStore at 2-8°C, protect from light
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
StabilityLight-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)9.5
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms1

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