Please note, this OEL/ADE monograph also applies to Gadoxetate disodium (CAS RN 135326-22-6). Gadoxetic acid (also known as gadoxetate) is a paramagnetic gadolinium-containing contrast agent in which its salt form, gadoxetate disodium, is used via intravenous (IV) injection. Ethoxybenzyl diethylenetriaminepentaacetic acid is the moiety that chelates with a gadolinium ion and forms a stable complex with it to make up the drug (3). When placed in a magnetic field, gadolinium produces a large magnetic moment and a large local magnetic field, which can enhance the relaxation rate of nearby protons. As a result, the signal intensity of tissue images observed with magnetic resonance imaging (MRI) may be enhanced. Because this agent is preferentially taken up by normal functioning hepatocytes, normal hepatic tissue is enhanced with MRI while tumor tissue is unenhanced. In addition, because this agent is excreted in the bile, it may be used to visualize the biliary system using MRI. Gadoxetate disodium is indicated for intravenous (IV) use in longitudinal relaxation time (T1)-weighted MRI of the liver to detect and characterize lesions in adults with known or suspected focal liver disease.
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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