Please note, this OEL/ADE monograph also applies to fexofenadine HCl (CAS RN 153439-40-8). Fexofenadine, the active metabolite of terfenadine, is indicated for chronic hives and seasonal allergic runny nose. Fexofenadine, the active metabolite of terfenadine, is a long lasting H1-receptor antagonist (antihistamine). Fexofenadine inhibits the release of histamine from mast cells and selectively antagonizes peripheral H1-receptor activity in the GI tract, large blood vessels, and bronchial smooth muscle, thereby blocking the action of histamine that leads to nasal congestion, runny nose, and other allergic reaction symptoms. It does not enter the brain, unlike most other antihistamines, and therefore, does not cause drowsiness; it also lacks the cardiotoxic potential of its parent drug, terfenadine.
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 Fexofenadine, 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.