Linagliptin Impurity 88 CAS 2489212-72-6

Description

Compared with other compounds in its class, the molecular weight of 957.10 g/mol gives Linagliptin Impurity 88 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

Linagliptin Impurity 88 (CAS 2489212-72-6) is a certified pharmaceutical impurity reference standard with the molecular formula C51H56N16O4 and a molecular weight of 957.10 g/mol.

Based on its molecular formula C51H56N16O4, Linagliptin Impurity 88 contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 957.10 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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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