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Synthesis of potential impurities of dabigatran etexilate

descriptionPublicationkeyboard_double_arrow_right Article , Other literature type 31 May 2017 English Publisher:Informa UK LimitedJournal:Synthetic Communications, volume 47, pages 1,225-1,230 (issn: 0039-7911, eissn: 1532-2432,

Authors: G. Srikanth; B. Sreenivasulu; D. Satheesh; U. Rajasekhar Reddy; Dhanraj T. S. S. Sundaram; S. Paul Douglas;

doi: 10.1080/00397911.2017.1321126 , 10.6084/m9.figshare.4954112 , 10.6084/m9.figshare.4954112.v2 , 10.6084/m9.figshare.4954112.v1

Synthesis of potential impurities of dabigatran etexilate

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Abstract

The present work describes the origin, control, and synthesis of two potent impurities of dabigatran etexilate 1, dabigatran dimer 2, and dabigatran n-propyl ester 3 from the commercially available raw materials 2-[(4-cyanophenyl)amino]acetic acid (4) and N-[3-amino-4-(methylamino)benzoyl]-N-2-pyridinyl-β-alanine ethyl ester (5). These impurities are the process-related impurities and may affect the quality of drug substance, during its manufacturing in large scale. These impurities are not only the crucial components in determining the quality and safety of the drug substance 1 but also provide a better understanding of impurity profiling.

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