Please note, this OEL/ADE monograph also applies to alternate CAS RN 9001-90-5. Fibrinolysin (also known as plasmin) is a proteolytic enzyme derived from the activation of human plasminogen. Fibrinolysin consists of two polypeptide chains, one light and one heavy, linked by a disulfide bond. The light chain has a molecular weight of approximately 27000 Da and contains the active center of fibrinolysin. The heavy chain has a molecular weight of approximately 57000 Da. Since fibrinolysin is an enzyme, chemical and physical characteristics are not applicable.
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:
The OEL/ADE monograph for Fibrinolysin is under development.
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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.