Please note, this OEL/ADE monograph also applies to tramadol hydrochloride (CAS RN 36282-47-0). Tramadol, an opioid analgesic, is indicated for the management of moderate to moderately severe pain in adults. Tramadol has a dual action of pain relief by acting as both a central opiate agonist and a central nervous system re-uptake inhibitor of norepinephrine and serotonin. (+)-Tramadol and its O-desmethyl metabolite (M1) are selective and weak μ (mu) receptor agonists, which in order, alter the release of nociceptive neurotransmitters. From these two molecules, M1 has 300 times more affinity for this receptor while (+)-tramadol also inhibits serotonin reuptake. On the other hand, (-)-tramadol inhibits norepinephrine reuptake.
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 Tramadol, 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.