Dabigatran Etexilate Amide Impurity

Dabigatran Etexilate Amide Impurity (CAS 1580491-16-2) is a structurally related degradation product arising from the hydrolytic conversion of the γ-glutamyl ester in dabigatran etexilate to an amide linkage. This impurity retains the core benzimidazole scaffold and tetrahydrofuran ring of the parent anticoagulant but features an amidic NH–CO–NR group in place of the esterified γ-carboxyglutamyl moiety. The substitution occurs at the C-terminal position of the prodrug’s peptidomimetic chain, altering its hydrogen-bonding capacity and metabolic stability. This compound serves as a critical HPLC reference standard for quantifying amide pathway impurities in dabigatran formulations.