Sulindac Impurity N93 CAS 55707-59-0

Description

The occurrence of Sulindac Impurity N93 is closely related to a steroid core, a sulfone group, a hydroxyl group, an ether linkage, fluorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

Sulindac Impurity N93 (CAS 55707-59-0) is a certified pharmaceutical impurity reference standard with the molecular formula C21H19FO3S and a molecular weight of 370.44 g/mol.

Based on its molecular formula C21H19FO3S, Sulindac Impurity N93 contains a steroid core, a sulfone group, a hydroxyl group, an ether linkage, fluorine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 370.44 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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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