Falecalcitriol impurity 4 CAS CATO-C4X-31414

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-31414
Molecular FormulaC18H28F6O2
Molecular Weight390.40 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Falecalcitriol impurity 4 CAS CATO-C4X-31414 chemical structure

Description

As a process- or degradation-related impurity, Falecalcitriol impurity 4 (CAS CATO-C4X-31414, C18H28F6O2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

The molecular framework of Falecalcitriol impurity 4 (C18H28F6O2) is characterized by a carboxylic acid group, a hydroxyl group, an ether linkage, fluorine substitution. 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. 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), Falecalcitriol impurity 4 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 FormulaC18H28F6O2
Molecular Weight390.40 g/mol
Purity97%+
StorageStore at room temperature
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
StabilityContains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)2.0
Halogen ContentF-containing

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