Please note, this OEL/ADE monograph also applies to heparin sodium (CAS RN 9041-08-1). Heparin is indicated for the anticoagulant therapy, blood clot disorders, hemodialysis, and heart surgery. Heparin sodium, a glycosaminoglycan, inhibits the mechanisms that induce the clotting of blood and the formation of stable fibrin clots at various sites in the normal coagulation system. When heparin sodium is combined with anti-thrombin III (heparin cofactor), thrombosis is blocked through inactivation of activated Factor X and inhibition of prothrombin's conversion to thrombin. This also prevents fibrin formation from fibrinogen during active thrombosis.
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:
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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.