Telmisartan Impurity N2 CAS 34981-09-4

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Telmisartan Impurity N2.

As a process- or degradation-related impurity, Telmisartan Impurity N2 (CAS 34981-09-4, C17H15N7) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Telmisartan Impurity N2 (C17H15N7) contains a nitrogen-containing heterocyclic scaffold, a nitrile group. Its physicochemical properties are representative of its class; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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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