Please note, this OEL/ADE monograph also applies to methyldopa sesquihydrate (CAS RN 41372-08-1). Methyldopa is indicated for high blood pressure. The exact mechanism of antihypertensive action has not been conclusively demonstrated. However, the major antihypertensive effect appears to result from conversion to alphamethylnorepinephrine, a potent alpha-2 adrenergic agonist. Alpha-methylnorepinephrine acts centrally to stimulate alpha receptors. This results in a decrease in sympathetic outflow and decreased blood pressure.
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.