Safinamide Impurity 33 CAS 405-85-6

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.405-85-6
Molecular FormulaC14H11FO3
Molecular Weight246.23 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Safinamide Impurity 33 CAS 405-85-6 chemical structure

Description

Compared with other compounds in its class, the molecular weight of 246.23 g/mol gives Safinamide Impurity 33 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

Safinamide Impurity 33 (CAS 405-85-6) is a certified pharmaceutical impurity reference standard with the molecular formula C14H11FO3 and a molecular weight of 246.23 g/mol.

The molecular framework of Safinamide Impurity 33 (C14H11FO3) is characterized by a carboxylic acid group, a hydroxyl group, an ether linkage, fluorine substitution, a polycyclic aromatic system. In reversed-phase chromatography, its retention is governed primarily by its high hydrophobicity (logP), which provides a practical basis for HPLC-UV/DAD or LC-MS method development. 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 FormulaC14H11FO3
Molecular Weight246.23 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, keep tightly closed to prevent evaporation
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
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
CAS Registry Year (est.)1957
Halogen ContentF-containing

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