OEL Fastrac Catalog

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.

Why do you need this OEL Fastrac monograph?

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:

• The numerical OEL and control band assignment needed to determine the level of required engineering controls and personal protective equipment
• A listing of all cited references utilized in the derivation of the OEL and ADE
• An expert review and discussion with respect to the critical endpoints of concern, the rationale for the choice of endpoints, and dose that is to be used in the derivation of the ADE (PDE), as required by the EMA's Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities

Benefits of OEL Fastrac monographs

• Fully documented. Over 20 pages in length, with calculations and cited references.
• Save time! Unsurpassed delivery with instant download.
• Save money. Similar documents cost 5-12 times as much.
• Stay current. Automatic notification of revisions.

How to order

To order an OEL/ADE monograph for Magnesium Orotate, just click the ADD TO CART button.

HBEL

If you're wondering about HBEL, we have something for you.