OEL Fastrac Catalog

Gadopentetate dimeglumine, which is a gadolinium coordination compound, consists of gadolinium and a chelating agent called diethylenetriaminepentaacetic acid (DTPA). Its primary purpose is to serve as a contrast agent for magnetic resonance imaging (MRI) in diagnostic procedures. This contrast agent utilizes gadolinium, a rare earth element known for its paramagnetic properties. It is specifically indicated for enhancing contrast in cranial and spinal MRI examinations for both adults and children. Its use helps in identifying lesions associated with abnormal vascularity or those suspected of affecting the blood-brain barrier.

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 Gadopentetate Dimeglumine, just click the ADD TO CART button.

HBEL

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