Sofosbuvir is an oral nucleotide analogue inhibitor indicated for treatment of chronic hepatitis C virus (HCV). It is used in combination with other antivirals, including ledipasvir, velpatasvir, and ribavirin, to treat HCV genotypes without cirrhosis or with compensated cirrhosis. Sofosbuvir is an antiviral agent that acts directly against the HCV via inhibition of the HCV NS5B RNA-dependent RNA polymerase, an enzyme essential for viral replication. Sofosbuvir is a nucleotide prodrug that undergoes intracellular metabolism to form the pharmacologically active uridine analog triphosphate, which can be incorporated into HCV RNA by the NS5B polymerase and acts as a chain terminator; thereby, preventing viral replication.
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 Sofosbuvir, just click the ADD TO CART button.
If you're wondering about HBEL, we have something for you.
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.