OEL Fastrac Catalog

Ferric ammonium citrate is given orally as a source of iron for iron-deficiency anemia. It is also used as a food additive, nutrient supplement, as an acidity regulator, anticaking agent, or as a coloring agent. Another use has been as an oral contrasting agent in magnetic resonance imaging of the upper abdomen. Based on literature, iron absorbed from ferric ammonium citrate preparations would undergo the same distribution and metabolic processes as the iron from other oral formulations or dietary sources. It would likely enter the hematopoietic pathway and would be incorporated into the hemoglobin of the red blood cells; the remainder would be incorporated into the ferritin for storage.

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 Ferric Ammonium Citrate, just click the ADD TO CART button.

HBEL

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