Please note, this OEL/ADE monograph also applies to amiodarone hydrochloride (CAS RN 19774-82-4). Amiodarone is used for life-threatening recurrent ventricular fibrillation or unstable tachycardia. Amiodarone is not considered a first-line agent for any arrhythmia. Amiodarone is a multiclass wide spectrum anti-arrhythmic agent used for ventricular fibrillation and hemodynamically unstable ventricular tachycardia. The antiarrhythmic effect of amiodarone is due to the prolongation of the myocardial cell action potential duration, repolarization time, and refractory period of the cardiac tissue. The cardiac refractory period is increased without affecting resting membrane potential.
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:
To order an OEL monograph for this compound, just click the ADD TO CART button.
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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.