OEL Fastrac Catalog

Iron is an essential trace element required by all forms of life. In man it is required for the synthesis of heme proteins which function in the process of oxygen transport and oxidative metabolism. They include hemoglobin, myoglobin, the cytochromes as well as catalase and peroxides. Other enzyme systems such as succinic dehydrogenase, mitochondrial nicotinamide adenine dinucleotide hydrogen (NADH)-dehydrogenase and xanthine oxidase contain nonheme iron. In other enzyme systems, such as aconitase, iron is a cofactor. Iron occurs as a natural constituent of all foods of plant and animal origin and may also be present in drinking-water. In food, iron occurs in three forms, iron oxides, inorganic and organic salts, and organic complexes such as heme iron. The chemical form of iron is important in assessing its biological availability. In addition, food may be fortified with iron salts or elemental iron. Most of the iron in the diet of people living in the United States (US) is derived from meat and grain products.

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 Iron Hydroxide, just click the ADD TO CART button.

HBEL

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