Please note, this OEL/ADE monograph also applies to benserazide hydrochloride (CAS RN 14919-77-8). Benserazide is a peripheral decarboxylase inhibitor indicated for the treatment of Parkinson’s disease in combination with levodopa. Benserazide, a peripheral decarboxylase inhibitor, blocks the decarboxylation of levodopa, the metabolic precursor of dopamine. Dopamine is depleted in the brain of Parkinson’s patients. Benserazide is hydroxylated to trihydroxybenzylhydrazine in the intestinal mucosa and the liver. It is a potent inhibitor of the aromatic amino acid decarboxylase and protects levodopa from decarboxylation to dopamine in the intestine, before it passes the bloodbrain barrier. Benserazide also inhibits other peripheral enzymes, but is significantly more specific to decarboxylase. Administration of benserazide with levodopa allows levodopa to exert its primary action in the central nervous system (CNS), rather than in peripheral tissue, which can cause adverse effects including nausea, vomiting, and cardiac arrhythmias. No other pharmacodynamic effects of benserazide, other than decarboxylase inhibition, have been reported.
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.