Lifitegrast Impurity 166 CAS CATO-C4X-2409166

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-2409166
Molecular FormulaC18H16Br2N2O2
Molecular Weight452.14 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Lifitegrast Impurity 166 CAS CATO-C4X-2409166 chemical structure

Description

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.

CATO supplies Lifitegrast Impurity 166 (CAS CATO-C4X-2409166), a pharmacopoeial impurity reference standard (molecular formula C18H16Br2N2O2, MW 452.14 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C18H16Br2N2O2, Lifitegrast Impurity 166 contains a steroid core, an amide group, a hydroxyl group, an ether linkage, bromine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 452.14 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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.

Physical & Chemical Properties

Molecular FormulaC18H16Br2N2O2
Molecular Weight452.14 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor, low volatility)
Purity≥95%
StorageStore in a cool place (≤25°C), protect from light, keep sealed and dry
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)11.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentBr-containing
Nitrogen Atoms2

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