Ponatinib Impurity 52 CAS 31719-79-6

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.31719-79-6
Molecular FormulaC8H7IO2
Molecular Weight262.04 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Ponatinib Impurity 52 CAS 31719-79-6 chemical structure

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Ponatinib Impurity 52.

As a process- or degradation-related impurity, Ponatinib Impurity 52 (CAS 31719-79-6, C8H7IO2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Ponatinib Impurity 52 (C8H7IO2) contains a carboxylic acid group, a hydroxyl group, an ether linkage, iodine substitution, an aromatic ring system. 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 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 52 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 FormulaC8H7IO2
Molecular Weight262.04 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor)
Purity≥95%
StorageStore at room temperature, keep tightly closed to prevent evaporation
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityMay oxidize slowly on prolonged air exposure; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)5.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1966
Halogen ContentI-containing

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