Please note, this OEL/ADE monograph also applies to valacyclovir hydrochloride (CAS RN 124832-27-5).
Valacyclovir (aka Valaciclovir) is indicated for the treatment of cold sores (herpes labialis), genital herpes, reduction of transmission of genital herpes, shingles (herpes zoster, and suppression therapy for herpes. Valacyclovir hydrochloride (the L-valyl ester prodrug of acyclovir) is a nucleoside analogue DNA polymerase inhibitor. After conversion to acyclovir, the drug binds selectively to thymidine kinase (encoded by herpes simplex virus and varicella-zoster virus) and converts to acyclovir monophosphate. After conversion ultimately to a triphosphate form, acyclovir triphosphate stops replication of herpes viral DNA through competitive inhibition and inactivation of viral DNA polymerase and incorporation and termination of the growing viral DNA chain.
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 Valacyclovir, 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.