Lercanidipine Impurity 34 CAS 28075-29-8

Description

The occurrence of Lercanidipine Impurity 34 is closely related to a nitrogen-containing heterocyclic scaffold, a nitrile group in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

Lercanidipine Impurity 34 (CAS 28075-29-8) is a certified pharmaceutical impurity reference standard with the molecular formula C16H19N and a molecular weight of 225.33 g/mol.

Structurally, Lercanidipine Impurity 34 (C16H19N) contains a nitrogen-containing heterocyclic scaffold, a nitrile group. The molecule exhibits a degree of unsaturation (DBE) of 8.0, corresponding to approximately 8 ring(s) or double-bond equivalent(s). With a molecular weight of 225.33 g/mol, it falls into the medium-molecular-weight range. 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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