Ponatinib Impurity 35 CAS CATO-C4X-226935

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-226935
Molecular FormulaC8H5N3
Molecular Weight143.15 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Ponatinib Impurity 35 CAS CATO-C4X-226935 chemical structure

Description

Ponatinib Impurity 35 (CAS CATO-C4X-226935) is a certified pharmaceutical impurity reference standard with the molecular formula C8H5N3 and a molecular weight of 143.15 g/mol.

Structurally, Ponatinib Impurity 35 (C8H5N3) contains a nitrogen-containing heterocyclic scaffold, a nitrile group. The molecule exhibits a degree of unsaturation (DBE) of 8.0, corresponding to approximately 8 ring(s) or double-bond equivalent(s). With a molecular weight of 143.15 g/mol, it falls into the low-molecular-weight range. 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.

The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.

Physical & Chemical Properties

Molecular FormulaC8H5N3
Molecular Weight143.15 g/mol
Purity≥95%
StorageStore at 2-8°C, protect from light
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityLight-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)8.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms3

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