Lemborexant Impurity 57 CAS CATO-C4X-304257

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-304257
Molecular FormulaC13H15FO3
Molecular Weight238.25 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Lemborexant Impurity 57 CAS CATO-C4X-304257 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 Lemborexant Impurity 57.

CATO supplies Lemborexant Impurity 57 (CAS CATO-C4X-304257), a pharmacopoeial impurity reference standard (molecular formula C13H15FO3, MW 238.25 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C13H15FO3, Lemborexant Impurity 57 contains a carboxylic acid group, a hydroxyl group, an ether linkage, fluorine substitution, an aromatic ring system; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 238.25 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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 FormulaC13H15FO3
Molecular Weight238.25 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor)
Purity97%+
StorageStore at 2-8°C, protect from light, keep sealed and dry, keep tightly closed to prevent evaporation
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
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)6.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentF-containing

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