Please note, this OEL/ADE monograph also applies to varenicline tartrrate (CAS RN 375815-87-5). Varenicline tartrate is indicated for use as an aid to smoking cessation treatment. Varenicline tartrate when used as an aid for smoking cessation treatment does so by blocking the pleasant effects of nicotine from the brain. This occurs through varenicline having a high affinity and selectivity at α4β2 neuronal nicotinic acetylcholine receptors. Binding at this site produces agonist activity while simultaneously preventing nicotine from binding to these receptors.
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), and to obtain the following information:
To order an OEL/ADE monograph for Varenicline, 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.