Vonoprazan Impurity 185 CAS CATO-C4X-1020185

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-1020185
Molecular FormulaC21H18FN3O5S
Molecular Weight443.45 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Vonoprazan Impurity 185 CAS CATO-C4X-1020185 chemical structure

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Vonoprazan Impurity 185.

CATO supplies Vonoprazan Impurity 185 (CAS CATO-C4X-1020185), a pharmacopoeial impurity reference standard (molecular formula C21H18FN3O5S, MW 443.45 g/mol) used for the identification and quantification of trace impurities in APIs.

Vonoprazan Impurity 185 (C21H18FN3O5S) contains a flavonoid core, an amide group, a sulfone 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. 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 FormulaC21H18FN3O5S
Molecular Weight443.45 g/mol
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)14.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentF-containing
Nitrogen Atoms3
Sulfur Atoms1

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