Sofosbuvir Impurity 23 CAS CATO-C4X-105223

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-105223
Molecular FormulaC22H29FN3O9P
Molecular Weight529.45 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Sofosbuvir Impurity 23 CAS CATO-C4X-105223 chemical structure

Description

The occurrence of Sofosbuvir Impurity 23 is closely related to a flavonoid core, an amide group, a phosphate ester group, a hydroxyl group, an ether linkage, fluorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

CATO supplies Sofosbuvir Impurity 23 (CAS CATO-C4X-105223), a pharmacopoeial impurity reference standard (molecular formula C22H29FN3O9P, MW 529.45 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Sofosbuvir Impurity 23 (C22H29FN3O9P) contains a flavonoid core, an amide group, a phosphate ester group, a hydroxyl group, an ether linkage, fluorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 9.5, corresponding to approximately 9 ring(s) or double-bond equivalent(s). With a molecular weight of 529.45 g/mol, it falls into the moderately-high-molecular-weight range. 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.

As a certified reference material (CRM), Sofosbuvir Impurity 23 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 FormulaC22H29FN3O9P
Molecular Weight529.45 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)9.5
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentF-containing
Nitrogen Atoms3

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