Trometamol is indicated for the treatment of metabolic acidosis and alkalinization regime. Trometamol is a fluid replenisher and a parenteral systemic alkalizer that acts as a proton acceptor and binds hydrogen ions actively, thereby preventing or correcting acidosis. It elevates bicarbonate anion concentration by binding to hydrogen ions of carbonic acid. It also exhibits an osmotic diuretic activity (helps the body eliminate fluid); which, increases urine flow, urinary pH and excretes fixed acids, carbon dioxide and electrolytes.
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.