Sofosbuvir Impurity 89 CAS CATO-C4X-105289

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-105289
Molecular FormulaC16H18FN2O8P
Molecular Weight416.29 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Sofosbuvir Impurity 89 CAS CATO-C4X-105289 chemical structure

Description

As a process- or degradation-related impurity, Sofosbuvir Impurity 89 (CAS CATO-C4X-105289, C16H18FN2O8P) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Sofosbuvir Impurity 89 (C16H18FN2O8P) contains a flavonoid core, an amide group, a phosphate ester group, a hydroxyl group, an ether linkage, fluorine substitution. It is notably hygroscopic, 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. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

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.

As a certified reference material (CRM), Sofosbuvir Impurity 89 meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

Physical & Chemical Properties

Molecular FormulaC16H18FN2O8P
Molecular Weight416.29 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
Purity97%+
StorageStore in a cool place (≤25°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)8.5
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentF-containing
Nitrogen Atoms2

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