Ledipasvir Impurity 55 CAS CATO-C4X-331355

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Ledipasvir Impurity 55.

CATO supplies Ledipasvir Impurity 55 (CAS CATO-C4X-331355), a pharmacopoeial impurity reference standard (molecular formula C49H54F2N8O6, MW 889.00 g/mol) used for the identification and quantification of trace impurities in APIs.

Owing to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine substitution, Ledipasvir Impurity 55 is typically pale yellow to yellow amorphous powder. Its solid-state physicochemical attributes — including a molecular weight of 889.00 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

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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