Apalutamide Impurity 53 CAS 1805120-01-7

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.1805120-01-7
Molecular FormulaC7H2F3N3O2
Molecular Weight217.10 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Apalutamide Impurity 53 CAS 1805120-01-7 chemical structure

Description

Based on its molecular formula C7H2F3N3O2, Apalutamide Impurity 53 contains an amide group, a carboxylic acid group, a hydroxyl group, an ether linkage, fluorine substitution, an aromatic ring system; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 217.10 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

Apalutamide Impurity 53 (CAS 1805120-01-7) is a certified pharmaceutical impurity reference standard with the molecular formula C7H2F3N3O2 and a molecular weight of 217.10 g/mol.

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 FormulaC7H2F3N3O2
Molecular Weight217.10 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor, faint amine-like odor, low volatility)
Purity>95%
StorageStore at 2-8°C, protect from light, keep sealed and dry, 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; Hygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)7.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1995
Halogen ContentF-containing
Nitrogen Atoms3

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