Vonoprazan Impurity 212 CAS 2775441-80-8

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.2775441-80-8
Molecular FormulaC21H16FN3O5S2
Molecular Weight473.50 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Vonoprazan Impurity 212 CAS 2775441-80-8 chemical structure

Description

Vonoprazan Impurity 212 (C21H16FN3O5S2) 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. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

As a process- or degradation-related impurity, Vonoprazan Impurity 212 (CAS 2775441-80-8, C21H16FN3O5S2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

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 FormulaC21H16FN3O5S2
Molecular Weight473.50 g/mol
Purity>95%
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)15.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)2003
Halogen ContentF-containing
Nitrogen Atoms3
Sulfur Atoms2

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