Apalutamide Impurity 81 CAS CATO-C4X-274981

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-274981
Molecular FormulaC7H4F3N3
Molecular Weight187.12 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Apalutamide Impurity 81 CAS CATO-C4X-274981 chemical structure

Description

As a process- or degradation-related impurity, Apalutamide Impurity 81 (CAS CATO-C4X-274981, C7H4F3N3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Owing to a nitrile group, fluorine substitution, an aromatic ring system, Apalutamide Impurity 81 is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 187.12 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.

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 FormulaC7H4F3N3
Molecular Weight187.12 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor, faint amine-like odor, low volatility)
Purity97%+
StorageStore at 2-8°C, protect from light, keep tightly closed to prevent evaporation
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)6.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentF-containing
Nitrogen Atoms3

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