Please note, this OEL/ADE monograph also applies to eslicarbazepine base (CAS RN 104746-04-05). Eslicarbazepine acetate is an anticonvulsant indicated for the treatment of partial-onset seizures that are not adequately controlled with conventional therapy in adult, adolescents, and children above age 4 with epilepsy. The pharmacological activity of eslicarbazepine acetate is primarily exerted through the active metabolite, eslicarbazepine. The mechanism of action of eslicarbazepine is not well understood; however, it exerts anticonvulsant activity by inhibiting repeated neuronal firing and stabilizing the inactivated state of voltage-gated sodium channels. This prevents the return of the sodium channels to the activated state during which seizure activity can occur.
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 Eslicarbazepine acetate, 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.