Ponatinib Impurity 20 CAS CATO-C4X-226920

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-226920
Molecular FormulaC21H21F6N3O2
Molecular Weight461.40 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Ponatinib Impurity 20 CAS CATO-C4X-226920 chemical structure

Description

The occurrence of Ponatinib Impurity 20 is closely related to a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

CATO supplies Ponatinib Impurity 20 (CAS CATO-C4X-226920), a pharmacopoeial impurity reference standard (molecular formula C21H21F6N3O2, MW 461.40 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, fluorine substitution, Ponatinib Impurity 20 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 461.40 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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), Ponatinib Impurity 20 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 FormulaC21H21F6N3O2
Molecular Weight461.40 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)10.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentF-containing
Nitrogen Atoms3

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