Please note, this OEL/ADE monograph also applies to dabigatran etexilate (CAS RN 211915-06-9) and dabigatran etexilate mesylate (CAS RN 872728-81-9). Dabigatran etexilate is indicated for prevention of blood clot formation in multiple surgical procedures. Dabigatran and its active metabolites, acyl glucuronides, are competitive, direct thrombin inhibitors which prevent thrombus development. Dabigatran and its acyl glucuronides inhibit both free and clot-bound thrombin as well as thrombin-induced platelet aggregation.
Affygility Solutions has an occupational exposure limit (OEL) and control band assignment for this active pharmaceutical ingredient (API). This monograph also contains the acceptable daily exposure (ADE) value.
OEL Fastrac monographs are a cost-effective and convenient way to meet the requirements for PDEs (ADEs) contained in the EMA Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities (EMA/CHMP/CVMP/SWP/169430/2012), as well as PIC/S and ANVISA requirements, and to obtain the following information:
To order an OEL/ADE monograph for Dabigatran, just click the ADD TO CART button.
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Affygility Solutions’ OEL Fastrac service is an user-friendly system that enables us to make confident decisions and focus on moving the compound safely through our facility. We can quickly access the database to determine if a new drug is within the OEL Fastrac library, and if so, immediately download a detailed OEL banding report. The OEL Fastrac system has been a helpful tool in our overall EH&S program.