Note, this OEL/ADE monograph covers both rivastigmine and rivastigmine tartrate (CAS RN 129101-54-8). Rivastigmine is indicated to treat Alzheimer’s disease and dementia associated with Parkinson’s disease. Rivastigmine tartrate is a reversible cholinesterase inhibitor in which exact mode of action is unknown. It is thought to inhibit the hydrolytic action of cholinesterase resulting in increased acetylcholine concentrations.
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.