Mupirocin impurity 45 CAS CATO-C4X-170645

Description

The occurrence of Mupirocin impurity 45 is closely related to a carboxylic acid group, a hydroxyl group, an ether linkage, an aromatic ring system in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

As a process- or degradation-related impurity, Mupirocin impurity 45 (CAS CATO-C4X-170645, C26H42O9) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

The molecular framework of Mupirocin impurity 45 (C26H42O9) is characterized by a carboxylic acid group, a hydroxyl group, an ether linkage, an aromatic ring system. In reversed-phase chromatography, its retention is governed primarily by the polarity and ionization state of its functional groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. 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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