Please note, this OEL/ADE monograph also applies to the base molecule levocetirizine (CAS RN 130018-77-8) or the additional salt form levocetirizine hydrochloride (CAS RN 823178-28-5).Levocetirizine dihydrochloride is indicated for treating perennial and seasonal allergic rhinitis. It is also used for idiopathic itchy skin conditions. Levocetirizine dihydrochloride, a second generation antihistamine with relatively less sedating activity than first generation drugs, is a histamine H1 receptor antagonist. Levocetirizine has been demonstrated to be the more active isomer of cetirizine.
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.