Telmisartan Impurity 10 CAS 73902-64-4

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 10.

CATO supplies Telmisartan Impurity 10 (CAS 73902-64-4), a pharmacopoeial impurity reference standard (molecular formula C8H12N2, MW 136.19 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Telmisartan Impurity 10 (C8H12N2) is characterized by a nitrogen-containing heterocyclic scaffold, a nitrile group. 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. 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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