Vonoprazan Impurity 154 CAS 5402-20-0

Description

The occurrence of Vonoprazan Impurity 154 is closely related to an amide group, a sulfone group, a carboxylic acid group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

As a process- or degradation-related impurity, Vonoprazan Impurity 154 (CAS 5402-20-0, C5H5NO3S) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Structurally, Vonoprazan Impurity 154 (C5H5NO3S) contains an amide group, a sulfone group, a carboxylic acid group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 4.0, corresponding to approximately 4 ring(s) or double-bond equivalent(s). With a molecular weight of 159.16 g/mol, it falls into the medium-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

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