Please note, this OEL/ADE monograph also applies to mirtazapine HCl (CAS RN 207516-99-2), mirtazapine maleate (CAS RN 85650-53-9), mirtazapine hemihydrate (CAS RN 341512-89-8), and mirtazapine hydrobromide (CAS RN 868363-97-7). Mirtazapine is a tetracyclic piperazino-azepine antidepressant agent indicated for the treatment of major depressive disorder (MDD) and its associated symptoms. The mechanism of action of mirtazapine is not fully understood but may be explained by its effects on central adrenergic and serotonergic activity. Mirtazapine exhibits a fast onset of action, a high level of response, a manageable side-effect profile, and dual noradrenergic and serotonergic effects that are unique from the effects of other antidepressants. It has been shown that both noradrenergic and serotonergic activity increase following mirtazapine administration.
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 Mirtazapine, just click the ADD TO CART button.
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Not the compound you were looking for? You can search the OEL Fastrac catalog to find more available compounds.
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.