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Molecules 2016, 21(8), 1041;

Synthesis and Characterization of Process-Related Impurities of Antidiabetic Drug Linagliptin

Shanghai Institute of Pharmaceutical Industry, China State Institute of Pharmaceutical Industry, 285 Gebaini Road, Pudong, Shanghai 201203, China
Authors to whom correspondence should be addressed.
Academic Editor: Diego Muñoz-Torrero
Received: 22 June 2016 / Revised: 3 August 2016 / Accepted: 5 August 2016 / Published: 9 August 2016
(This article belongs to the Section Medicinal Chemistry)
Full-Text   |   PDF [1927 KB, uploaded 10 August 2016]   |  


Linagliptin, a xanthine derivative, is a highly potent, selective, long-acting and orally bioavailable DPP-4 inhibitor for the treatment of type 2 diabetes. During the process development of linagliptin, five new process-related impurities were detected by high performance liquid chromatography (HPLC). All these impurities were identified, synthesized, and subsequently characterized by their respective spectral data (MS, HRMS, 1H-NMR, 13C-NMR and IR) as described in this article. The identification of these impurities should be useful for quality control and the validation of the analytical method in the manufacture of linagliptin. View Full-Text
Keywords: linagliptin; type 2 diabetes; impurities; synthesis; characterization linagliptin; type 2 diabetes; impurities; synthesis; characterization

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This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited (CC BY 4.0).

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Huang, Y.; He, X.; Wu, T.; Zhang, F. Synthesis and Characterization of Process-Related Impurities of Antidiabetic Drug Linagliptin. Molecules 2016, 21, 1041.

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