Lemborexant Impurity 46 CAS CATO-C4X-304246

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-304246
Molecular FormulaC22H21FN4O2
Molecular Weight392.43 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Lemborexant Impurity 46 CAS CATO-C4X-304246 chemical structure

Description

CATO supplies Lemborexant Impurity 46 (CAS CATO-C4X-304246), a pharmacopoeial impurity reference standard (molecular formula C22H21FN4O2, MW 392.43 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Lemborexant Impurity 46 (C22H21FN4O2) is characterized by a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, 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.

As a certified reference material (CRM), Lemborexant Impurity 46 meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

Physical & Chemical Properties

Molecular FormulaC22H21FN4O2
Molecular Weight392.43 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
Purity≥95%
StorageStore at 2-8°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)14.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentF-containing
Nitrogen Atoms4

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