Sunitinib Impurity 64 CAS CATO-C4X-133364

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-133364
Molecular FormulaC22H20FN5O3
Molecular Weight421.42 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Sunitinib Impurity 64 CAS CATO-C4X-133364 chemical structure

Description

As a certified reference material (CRM), Sunitinib Impurity 64 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.

CATO supplies Sunitinib Impurity 64 (CAS CATO-C4X-133364), a pharmacopoeial impurity reference standard (molecular formula C22H20FN5O3, MW 421.42 g/mol) used for the identification and quantification of trace impurities in APIs.

Sunitinib Impurity 64 (C22H20FN5O3) contains a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. It is notably hygroscopic, halogen substitution raises its density and boiling point, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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.

Physical & Chemical Properties

Molecular FormulaC22H20FN5O3
Molecular Weight421.42 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
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)15.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentF-containing
Nitrogen Atoms5

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