Ondansetron EP Impurity H CAS 99614-14-9

Description

Compared with other compounds in its class, the molecular weight of 279.34 g/mol gives Ondansetron EP Impurity H distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

Ondansetron EP Impurity H (CAS 99614-14-9) is a certified pharmaceutical impurity reference standard with the molecular formula C17H17N3O and a molecular weight of 279.34 g/mol.

The molecular framework of Ondansetron EP Impurity H (C17H17N3O) is characterized by a steroid core, an amide group, a hydroxyl group, an ether linkage. 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 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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