Please note, this OEL/ADE monograph also applies to Hirudin lepirudin (CAS RN 138068-37-8). Hirudin is a single chain of polypeptides of about 65 amino acids from leeches that have a neutral hydrophobic N terminus, an acidic hydrophilic C terminus, and a compact, hydrophobic core region. Recombinant hirudin, known as lepirudin, is indicated for anticoagulation in patients with heparin-induced thrombocytopenia type II (HIT) and associated thromboembolism. Recombinant hirudin differs from naturally occurring hirudin by substitution of leucine for isoleucine at the N-terminal end of the molecule and by absence of a sulfate group on the tyrosine at position 63. Recombinant hirudin is a highly specific inhibitor of the thrombogenic activity of thrombin by forming a stable, non-covalent complex with α- thrombin, thereby abolishing its ability to cleave fibrinogen (1, 2, 4). It produces dosedependent increases in activated partial thromboplastin time (aPTT). Its action is independent of antithrombin III and it is not inhibited by platelet factor 4.
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.
Please note: Due to the complexity and amount of studies regarding this compound—a Natural Health Product—increased cost is charged.
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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