Vonoprazan Impurity 195 CAS 1126403-28-8

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.1126403-28-8
Molecular FormulaC20H33N3O4
Molecular Weight379.49 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Vonoprazan Impurity 195 CAS 1126403-28-8 chemical structure

Description

Vonoprazan Impurity 195 (CAS 1126403-28-8) is a certified pharmaceutical impurity reference standard with the molecular formula C20H33N3O4 and a molecular weight of 379.49 g/mol.

Based on its molecular formula C20H33N3O4, Vonoprazan Impurity 195 contains a steroid core, an amide group, a hydroxyl group, an ether linkage; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 379.49 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

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 FormulaC20H33N3O4
Molecular Weight379.49 g/mol
AppearanceOff-white to pale yellow crystalline powder
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
Degree of Unsaturation (DBE)6.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1989
Nitrogen Atoms3

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