Falecalcitriol impurity 6 CAS CATO-C4X-31416

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-31416
Molecular FormulaC18H24F6O
Molecular Weight370.37 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Falecalcitriol impurity 6 CAS CATO-C4X-31416 chemical structure

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Falecalcitriol impurity 6.

CATO supplies Falecalcitriol impurity 6 (CAS CATO-C4X-31416), a pharmacopoeial impurity reference standard (molecular formula C18H24F6O, MW 370.37 g/mol) used for the identification and quantification of trace impurities in APIs.

Falecalcitriol impurity 6 (C18H24F6O) contains a steroid core, a hydroxyl group, an ether linkage, fluorine substitution. Halogen substitution raises its density and boiling point, its high carbon-to-hydrogen ratio confers good lipid solubility; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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.

The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.

Physical & Chemical Properties

Molecular FormulaC18H24F6O
Molecular Weight370.37 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor, low volatility)
Purity97%+
StorageStore at room temperature
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
StabilityMay oxidize slowly on prolonged air exposure
Degree of Unsaturation (DBE)4.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentF-containing

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