Fluralaner Impurity 50 CAS 1309959-46-3

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.1309959-46-3
Molecular FormulaC19H12ClF6NO3
Molecular Weight451.75 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Fluralaner Impurity 50 CAS 1309959-46-3 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 Fluralaner Impurity 50.

CATO supplies Fluralaner Impurity 50 (CAS 1309959-46-3), a pharmacopoeial impurity reference standard (molecular formula C19H12ClF6NO3, MW 451.75 g/mol) used for the identification and quantification of trace impurities in APIs.

Fluralaner Impurity 50 (C19H12ClF6NO3) contains a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine/chlorine substitution. Halogen substitution raises its density and boiling point, its high carbon-to-hydrogen ratio confers good lipid solubility, the carboxyl group imparts weak acidity; 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.

CATO manufactures Fluralaner Impurity 50 under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.

Physical & Chemical Properties

Molecular FormulaC19H12ClF6NO3
Molecular Weight451.75 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor, low volatility)
Purity97%+
StorageStore at room temperature, 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; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)11.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1990
Halogen ContentF/Cl-containing
Nitrogen Atoms1

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