Please note, this OEL/ADE monograph also applies to tenofovir alafenamide (CAS RN 379270-37-8). Tenofovir alafenamide fumarate (TAF) is used to treat hepatitis B virus (HBV) as a single agent and human immunodeficiency virus (HIV) in combination with emtricitabine and rilpivirine. TAF is a phosphonamidate prodrug that is converted to tenofovir inside the cell. Intracellular tenofovir is subsequently phosphorylated by cellular kinases to the pharmacologically active metabolite tenofovir diphosphate. Tenofovir diphosphate inhibits HBV and HIV replication through incorporation into HBV and HIV DNA by the HBV and HIV reverse transcriptases, respectively.
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 Tenofovir Alafenamide Fumarate, just click the ADD TO CART button.
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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.