Ledipasvir Impurity 45 CAS CATO-C4X-331345

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-331345
Molecular FormulaC35H32N6O
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Ledipasvir Impurity 45 CAS CATO-C4X-331345 chemical structure

Description

CATO supplies Ledipasvir Impurity 45 (CAS CATO-C4X-331345), a pharmacopoeial impurity reference standard (molecular formula C35H32N6OHCl, MW 589.14 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Ledipasvir Impurity 45 (C35H32N6OHCl) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 22.0, corresponding to approximately 22 ring(s) or double-bond equivalent(s). With a molecular weight of 589.14 g/mol, it falls into the moderately-high-molecular-weight range. 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

Molecular FormulaC35H32N6O HCl
Molecular Weight589.14 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
Purity97%+
StorageStore at room temperature, protect from light
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)22.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentCl-containing
Nitrogen Atoms6

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