Safinamide Impurity 34 CAS CATO-C4X-159034

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-159034
Molecular FormulaC18H21FN2O2
Molecular Weight316.37 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Safinamide Impurity 34 CAS CATO-C4X-159034 chemical structure

Description

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.

Safinamide Impurity 34 (CAS CATO-C4X-159034) is a certified pharmaceutical impurity reference standard with the molecular formula C18H21FN2O2 and a molecular weight of 316.37 g/mol.

Based on its molecular formula C18H21FN2O2, Safinamide Impurity 34 contains a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 316.37 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).

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.

Physical & Chemical Properties

Molecular FormulaC18H21FN2O2
Molecular Weight316.37 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
Purity97%+
StorageStore at 2-8°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)9.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentF-containing
Nitrogen Atoms2

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