Please note, this OEL/ADE monograph also applies to tenofovir disoproxil fumarate (CAS RN 202138-50-9) and tenofovir disoproxil phosphate (CAS RN 1453166-76-1) Tenofovir disoproxil fumarate is used to treat human immunodeficiency virus (HIV) and chronic type B viral hepatitis. Tenofovir disoproxil fumarate, an acyclic nucleoside phosphonate diester analog of adenosine monophosphate, is a prodrug that requires diester hydrolysis for conversion to tenofovir. Subsequent phosphorylation by cellular enzymes forms tenofovir diphosphate, an obligate chain terminator. Tenofovir diphosphate competes with the natural substrate deoxyadenosine 5’-triphosphate for incorporation into the viral DNA strand. After incorporation into viral DNA, tenofovir diphosphate inhibits the activity of HIV-1 reverse transcriptase and HBV polymerase by terminating the DNA chain. Tenofovir diphosphate is also a weak inhibitor of mammalian DNA polymerases α, β, and mitochondrial DNA polymerase γ.
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 disoproxil, 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.