Canagliflozin impurity 117 CAS 1818268-44-8

Description

The occurrence of Canagliflozin impurity 117 is closely related to a steroid core, sulfur-containing functionality, a hydroxyl group, an ether linkage, fluorine/bromine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

As a process- or degradation-related impurity, Canagliflozin impurity 117 (CAS 1818268-44-8, C18H14BrFOS) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

The molecular framework of Canagliflozin impurity 117 (C18H14BrFOS) is characterized by a steroid core, sulfur-containing functionality, a hydroxyl group, an ether linkage, fluorine/bromine substitution. In reversed-phase chromatography, its retention is governed primarily by its high hydrophobicity (logP), which provides a practical basis for HPLC-UV/DAD or LC-MS method development. 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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