Note, this OEL Fastrac monograph also covers the salt form of phenylephrine HCl (CAS RN 61-76-7) and includes the pediatric ADE. Phenylephrine is indicated for nasal congestion, glaucoma, low blood pressure, induction of pupil dilation, and inflammation of the iris. Phenylephrine hydrochloride, a synthetic sympathomimetic agent, is a powerful postsynaptic alpha-receptor agonist with minimal effect on the beta-receptors of the heart. It exhibits a rapid and moderately extended vasoconstrictor and mydriatic action. Its action in the heart includes elevation of the heart rate and reduction of cardiac output.
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 Phenylephrine, just click the ADD TO CART button.
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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.