Please note, this OEL/ADE monograph also applies to doxepin hydrochloride (CAS RN 1229-29-4). Doxepin is indicated for the treatment of depression and anxiety. Doxepin belongs to a class of psychotherapeutic agents called dibenzoxepin tricyclic compounds. It has no known mechanism of action, although, its antidepressant effect is believed to be partly due to its influences on the adrenergic activity at the synapses where it prevents norepinephrine deactivation through reuptake into the nerve terminals. It is also known to have anticholinergic, antiserotonin and antihistamine effects.
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:
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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.