Omeprazole Impurity 50 CAS CATO-C4X-125550

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-125550
Molecular FormulaC17H16N4O2S2
Molecular Weight372.46 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Omeprazole Impurity 50 CAS CATO-C4X-125550 chemical structure

Description

As a process- or degradation-related impurity, Omeprazole Impurity 50 (CAS CATO-C4X-125550, C17H16N4O2S2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Structurally, Omeprazole Impurity 50 (C17H16N4O2S2) contains a steroid core, an amide group, a sulfone group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 12.0, corresponding to approximately 12 ring(s) or double-bond equivalent(s). With a molecular weight of 372.46 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.

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 FormulaC17H16N4O2S2
Molecular Weight372.46 g/mol
Purity≥95%
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)12.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms4
Sulfur Atoms2

Related Omeprazole Standards

Recommended Standards

Why CATO?