Please note, this OEL/ADE monograph also applies to ganciclovir sodium (CAS RN 107910-75-8). Ganciclovir is indicated for the treatment of cytomegalovirus and prevention of cytomegalovirus infection. Ganciclovir is an acyclic nucleoside analogue of 2'-deoxyguanosine which inhibits the replication of the cytomegalovirus (CMV) and herpes simplex virus. Ganciclovir is phosphorylated by CMV and then undergoes intracellular conversion to the triphosphate form. Ganciclovir triphosphate inhibits viral DNA synthesis by competitively inhibiting viral DNA polymerases and by getting incorporated into viral DNA resulting in chain termination.
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 Ganciclovir, just click the ADD TO CART button.
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Affygility Solutions’s 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.