Lifitegrast Impurity 45 CAS CATO-C4X-240945

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-240945
Molecular FormulaC21H20Cl2N4O3
Molecular Weight447.31 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Lifitegrast Impurity 45 CAS CATO-C4X-240945 chemical structure

Description

Compared with other compounds in its class, the molecular weight of 447.31 g/mol gives Lifitegrast Impurity 45 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

CATO supplies Lifitegrast Impurity 45 (CAS CATO-C4X-240945), a pharmacopoeial impurity reference standard (molecular formula C21H20Cl2N4O3, MW 447.31 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Lifitegrast Impurity 45 (C21H20Cl2N4O3) is characterized by a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine 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. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

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), Lifitegrast Impurity 45 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 FormulaC21H20Cl2N4O3
Molecular Weight447.31 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor, low volatility)
Purity97%+
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)13.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentCl-containing
Nitrogen Atoms4

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