Pantoprazole impurity 59 CAS CATO-C4X-139959

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-139959
Molecular FormulaC16H14F2N4O4S
Molecular Weight396.37 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Pantoprazole impurity 59 CAS CATO-C4X-139959 chemical structure

Description

Pantoprazole impurity 59 (CAS CATO-C4X-139959) is a certified pharmaceutical impurity reference standard with the molecular formula C16H14F2N4O4S and a molecular weight of 396.37 g/mol.

Structurally, Pantoprazole impurity 59 (C16H14F2N4O4S) contains a flavonoid core, an amide group, a sulfone group, a hydroxyl group, an ether linkage, fluorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 11.0, corresponding to approximately 11 ring(s) or double-bond equivalent(s). With a molecular weight of 396.37 g/mol, it falls into the moderately-high-molecular-weight range. 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 FormulaC16H14F2N4O4S
Molecular Weight396.37 g/mol
Purity97%+
StorageStore at 2-8°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)11.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentF-containing
Nitrogen Atoms4
Sulfur Atoms1

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