Fluralaner Impurity N1 CAS 1095275-07-2

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 N1.

CATO supplies Fluralaner Impurity N1 (CAS 1095275-07-2), a pharmacopoeial impurity reference standard (molecular formula C18H13Cl2F3O4, MW 421.19 g/mol) used for the identification and quantification of trace impurities in APIs.

Fluralaner Impurity N1 (C18H13Cl2F3O4) contains a flavonoid core, 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.

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

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