Bosutinib Impurity 16 CAS CATO-C4X-184716

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-184716
Molecular FormulaC26H31Cl2N5O4
Molecular Weight548.46 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Bosutinib Impurity 16 CAS CATO-C4X-184716 chemical structure

Description

CATO supplies Bosutinib Impurity 16 (CAS CATO-C4X-184716), a pharmacopoeial impurity reference standard (molecular formula C26H31Cl2N5O4, MW 548.46 g/mol) used for the identification and quantification of trace impurities in APIs.

Owing to a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution, Bosutinib Impurity 16 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 548.46 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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.

As a certified reference material (CRM), Bosutinib Impurity 16 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 FormulaC26H31Cl2N5O4
Molecular Weight548.46 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)13.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentCl-containing
Nitrogen Atoms5

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