Please note, this OEL/ADE monograph also applies to icosapent ethyl (CAS RN 86227-47-6) and icosapent sodium (CAS RN 73167-03-0). Icosapent is a naturally occurring omega-3-fatty acid and is indicated as an adjunct to diet to reduce triglyceride levels in adults with severe hypertriglyceridemia. Icosapent ethyl is an ethyl ester of eicosapentaenoic acid. Icosapent ethyl is converted to icosapent, eicosapentaenoic acid (EPA), an omega-3-fatty acid during absorption. It is thought that icosapent slows the synthesis or secretion of very low density lipoprotein triglycerides by the liver.
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 Icosapent, just click the ADD TO CART button.
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Not the compound you were looking for? You can search the OEL Fastrac catalog to find more available compounds.
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.