Amorolfine Impurity 57 CAS 3373-10-2

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.3373-10-2
Molecular FormulaC16H26
Molecular Weight218.38 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Amorolfine Impurity 57 CAS 3373-10-2 chemical structure

Description

As a process- or degradation-related impurity, Amorolfine Impurity 57 (CAS 3373-10-2, C16H26) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Amorolfine Impurity 57 (C16H26) contains an aromatic ring system. Its high carbon-to-hydrogen ratio confers good lipid solubility; these physicochemical properties determine the optimal preparation and storage of its standard solutions. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.

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), Amorolfine Impurity 57 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 FormulaC16H26
Molecular Weight218.38 g/mol
Purity97%+
StorageStore at room temperature
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate
StabilityStable under recommended storage conditions
Degree of Unsaturation (DBE)4.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1957

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