Riociguat Impurity N10 CAS 2101651-50-5

Description

Compared with other compounds in its class, the molecular weight of 269.28 g/mol gives Riociguat Impurity N10 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

Riociguat Impurity N10 (CAS 2101651-50-5) is a certified pharmaceutical impurity reference standard with the molecular formula C14H12FN5 and a molecular weight of 269.28 g/mol.

The molecular framework of Riociguat Impurity N10 (C14H12FN5) is characterized by a nitrogen-containing heterocyclic scaffold, a nitrile group, fluorine substitution. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

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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