Sotalol is non-cardioselective beta blocker used in the treatment of atrial arrhythmia and life-threatening ventricular arrhythmia. Sotalol is a beta-blocker without intrinsic sympathomimetic activity, membrane stabilizing activity (anesthetic activity), or cardioselectivity. Sotalol exerts antiarrhythmic effects, lengthening the action potential duration and prolonging the QTc interval on the electrocardiogram. The beta blocking effects appear to contribute substantially to the superior mortality reduction with sotalol. Sotalol prolongs atrial and ventricular repolarization which is associated with an increase in the effective refractory period of cardiac tissues. Note, this OEL and ADE monograph applies to both sotalol and sotalol hcl.
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.