Picosulfate impurity 21 CAS CATO-C4X-123721

Description

Compared with other compounds in its class, the molecular weight of 341.38 g/mol gives Picosulfate impurity 21 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

CATO supplies Picosulfate impurity 21 (CAS CATO-C4X-123721), a pharmacopoeial impurity reference standard (molecular formula C18H15NO4S, MW 341.38 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Picosulfate impurity 21 (C18H15NO4S) contains a flavonoid 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 341.38 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

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