Please note, this OEL/ADE monograph also applies to ferrous bisglycinate (CAS RN 20150-34-9) and ferrous bisglycinate dihydrochloride (CAS RN 67972-33-2). Ferrous bisglycinate (also known as ferrous glycinate) is an iron (II) chelate of the amino acid glycine. Iron is a mineral that is naturally present in many foods, is added to some food products, and is available as a dietary supplement. Ferrous bisglycinate (also known as ferrous glycinate) is an iron (II) chelate of the amino acid glycine. Iron is an essential component of hemoglobin, an erythrocyte (red blood cell) protein that transfers oxygen from the lungs to the tissues. Most of the 3 to 4 g of elemental iron in adults is found in hemoglobin.
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.