Lemborexant Impurity 92 CAS CATO-C4X-304292

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-304292
Molecular FormulaC11H9FO2
Molecular Weight192.19 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Lemborexant Impurity 92 CAS CATO-C4X-304292 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 92.

As a process- or degradation-related impurity, Lemborexant Impurity 92 (CAS CATO-C4X-304292, C11H9FO2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

The molecular framework of Lemborexant Impurity 92 (C11H9FO2) is characterized by a carboxylic acid group, a hydroxyl group, an ether linkage, fluorine substitution, an aromatic ring system. In reversed-phase chromatography, its retention is governed primarily by its high hydrophobicity (logP), which provides a practical basis for HPLC-UV/DAD or LC-MS method development. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

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 FormulaC11H9FO2
Molecular Weight192.19 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor)
Purity≥95%
StorageStore at 2-8°C, protect from light, 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; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)7.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentF-containing

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