Please note, this OEL/ADE monograph also applies to Gadoteric acid (CAS RN 72573-82-1) and Gadoterate sodium (CAS RN 92923-44-9). Gadoteric acid is a macrocycle-structured gadolinium-based magnetic resonance imaging (MRI) contrast agent. It is composed of the organic acid DOTA (1,4,7,10- tetraazacyclododecane-1,4,7,10-tetraacetic acid) used for its chelating properties, and gadolinium (Gd3+). Gadoteric acid is administered as the meglumine salt, gadoterate meglumine, and is indicated for MRI of brain and brain stem, for blood-brain barrier disruption or abnormal vascularity.
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:
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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.