Please note, this OEL/ADE monograph also applies to Magnesium orotate dihydrate (CAS RN 1381769-22-7). Magnesium orotate is a magnesium salt of orotic acid and is poorly soluble in water. It is a source of magnesium and is used as a mineral supplement to treat magnesium deficiency. Orotic acid acts as a transporter that carries magnesium into the cells. It also exhibits antioxidant properties, since it is a key intermediate in the biosynthetic pathway of pyrimidines that promotes the synthesis of enzymes which act as free-radical scavengers. Experiments investigating the potential cardioprotective actions of orotic acid in pathological heart conditions are still ongoing. Since binding sites for magnesium are provided by orotic acid, it can be classified as "magnesium-fixing agent". Accordingly, magnesium orotate is also indicated for the treatment of magnesium depletion as shown in animal experiments and also in coronary heart patients undergoing aortocoronary bypass surgery.
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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