Please note, this OEL/ADE monograph also applies to dexmedetomidine hydrochloride (CAS RN 145108-58-3). Dexmedetomidine is indicated for premedication for anesthetic procedures and for sedation. Dexmedetomidine is the active S-isomer of medetomidine. The S-enantiomer, dexmedetomidine is used as the hydrochloride for sedation in intensive care and in surgical and medical procedures. Dexmedetomidine, the active S-isomer of medetomidine, is an imidazole derivative, α2- adrenoceptor agonist with sedative, muscle relaxant, and analgesic properties. It inhibits the release of norepinephrine by binding to the presynaptic α2-adrenoceptors, thereby terminating the propagation of pain signals. Activation of the postsynaptic α2-adrenoceptors inhibits the sympathetic activity and decreases blood pressure and heart rate.
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.