Please note, this OEL/ADE monograph also applies to Vortioxetine hydrobromide (CAS RN 960203-27-4). Vortioxetine is indicated for the treatment of major depressive disorder. Vortioxetine is a serotonin modulator and simulator and has a multimodal mechanism of action towards the serotonin neurotransmitter system; it simultaneously modulates one or more serotonin receptors and inhibits the reuptake of serotonin (5-HT) through inhibition of the serotonin transporter. It acts as an antagonist of 5-HT3, 5-HT1D, and 5-HT7 receptors, an agonist of 5-HT1A receptors, and is a partial agonist of the 5-HT1B receptor.
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 Vortioxetine, 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.