Dabigatran

Dabigatran Impurities

Dabigatran is a direct thrombin inhibitor used as an oral anticoagulant for the prevention and treatment of thromboembolic disorders. Its impurity profile includes structurally related analogs, residual solvents, and degradation products formed under stress conditions such as hydrolysis, oxidation, and photolysis. Degradation pathways typically involve hydrolytic cleavage of the ester prodrug moieties, oxidation of the aromatic rings, and rearrangement of the amidine group. These impurities may affect the drug’s potency, stability, and safety. All impurities are structurally characterized and qualified in accordance with ICH guidelines for toxicological assessment and analytical validation.

Dabigatran EP Impurities

Pharmacopeial and non-pharmacopeial Dabigatran impurity compounds are available in compliance with European Pharmacopoeia (EP) specifications. These standards support analytical method development, impurity profiling, and long-term stability studies. EP traceable materials are supplied with validated analytical data, including purity, structural confirmation, and spectral characterization.

Dabigatran Related Compounds

Structurally related compounds and synthetic analogs associated with Dabigatran are included for use in impurity identification, toxicological qualification, and regulatory submission. These related substances are used in forced degradation studies, genotoxicity assessments, and impurity threshold evaluations. They are essential for understanding the impurity profile and ensuring compliance with regulatory limits.

Dabigatran Impurity Reference Standards

Dabigatran impurity reference standards are provided with validated analytical data, including purity, NMR, MS, and full Certificates of Analysis. These standards are used in pharmaceutical research, method validation, and GMP-compliant quality control. EP/USP traceable entries are available upon request and are routinely re-tested to ensure consistency and reliability.