Please note, this OEL/ADE monograph also applies to Dronedarone hydrochloride (CAS RN 141625-93-6). Dronedarone is used to treat people who have had atrial fibrillation (a heart rhythm disorder that may cause the heartbeat to be fast and irregular) or atrial flutter (a heart rhythm disorder that may cause the heartbeat to be fast but regular) during the past 6 months and who also have certain other conditions that increase the risk that they will develop heart problems. Dronedarone decreases the risk that people who have these conditions will need to be hospitalized to treat heart problems. Dronedarone is in a class of medications called antiarrhythmics. It works by helping the heart to beat normally.
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 Dronedarone, 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.