Samidorphan Impurity 8 CAS CATO-C4X-33098

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-33098
Molecular FormulaC21H24F3NO6S
Molecular Weight475.48 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Samidorphan Impurity 8 CAS CATO-C4X-33098 chemical structure

Description

Samidorphan Impurity 8 (CAS CATO-C4X-33098) is a certified pharmaceutical impurity reference standard with the molecular formula C21H24F3NO6S and a molecular weight of 475.48 g/mol.

Samidorphan Impurity 8 (C21H24F3NO6S) contains a flavonoid core, an amide group, a sulfone group, a hydroxyl group, an ether linkage, fluorine substitution. Halogen substitution raises its density and boiling point, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

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 FormulaC21H24F3NO6S
Molecular Weight475.48 g/mol
Purity≥95%
StorageStore at room temperature, protect from light, keep sealed and dry
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; 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 Atoms1
Sulfur Atoms1

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