OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to tenofovir disoproxil fumarate (CAS RN 202138-50-9), tenofovir disoproxil phosphate (CAS RN 1453166-76-1), Tenofovir disoproxil succinate (CAS RN 1637632-97-3), Tenofovir disoproxil hemiedisylate (CAS RN 1859973-28-6), Tenofovir disoproxil maleate (CAS RN 1276030-80-8), Tenofovir disoproxil aspartate (CAS RN Not Available), and Tenofovir disoproxil orotate (CAS RN 1636180-90-9). 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.

Why do you need this OEL Fastrac monograph?

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 numerical OEL and control band assignment needed to determine the level of required engineering controls and personal protective equipment
• A listing of all cited references utilized in the derivation of the OEL and ADE
• An expert review and discussion with respect to the critical endpoints of concern, the rationale for the choice of endpoints, and dose that is to be used in the derivation of the ADE (PDE), as required by the EMA's Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities

Benefits of OEL Fastrac monographs

• Fully documented. Over 20 pages in length, with calculations and cited references.
• Save time! Unsurpassed delivery with instant download.
• Save money. Similar documents cost 5-12 times as much.
• Stay current. Automatic notification of revisions.

How to order

To order an OEL/ADE monograph for Tenofovir Disoproxil, just click the ADD TO CART button.

HBEL

If you're wondering about HBEL, we have something for you.