Please note, this OEL/ADE monograph also applies to tosylate (CAS RN 480449-71-6) and tosylate monohydrate (CAS RN 1229194-11-9). Edoxaban is an anticoagulant indicated for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial, fibrillation. Edoxaban, a member of the novel oral anti-coagulants (NOACs) class of drugs, is a rapidly acting, oral, selective factor Xa inhibitor, which is a key protein in the coagulation cascade. By inhibiting factor Xa, edoxaban prevents amplification of protein factors needed to form blood clots and platelet aggregation, reduces thrombin generation and thrombus formation, and thereby prolongs clotting time.
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), and to obtain the following information:
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Affygility Solutions’s 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.