Please note, this OEL/ADE monograph also applies to benztropine mesylate (CAS RN 132-17-2). Benzatropine (benztropine) is a centrally active muscarinic antagonist indicated as an adjunct in the treatment of parkinsonism and in the treatment of extrapyramidal symptoms. Benzatropine is a potent inhibitor of presynaptic carrier-mediated dopamine transport. As a known analog of atropine, it has a high affinity for muscarinic receptors in the human brain. Once bound, benzatropine blocks the activity of muscarinic receptors, mainly in the striatum. The antagonism of acetylcholine corrects the imbalance between dopamine and acetylcholine in Parkinson’s patients. Benzatropine may also block dopamine reuptake, thereby increasing dopaminergic activity. In animal studies, the anticholinergic activity of benzatropine was about equal to that of atropine.
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:
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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.