OEL Fastrac Catalog

Pentetic acid is also known as diethylenetriaminepentaacetic acid (DTPA). Pentetic acid and its salts are chelators with the general properties of the edetates. Calcium trisodium pentetate and zinc trisodium pentetate are used in the treatment of poisoning by radioactive metals such as plutonium, americium, and curium. Pentetates, labeled with metallic radionuclides, are used in nuclear medicine. Due to the pharmacokinetic elimination by the kidneys, pentetic acid conjugated with technetium-99m (Tc 99m) is being used clinically to estimate physiological parameters such as glomerular filtration rate and effective renal plasma flow. Pentetic acid after conjugation with Tc 99m is also indicated for brain imaging, renal visualization and lung ventilation imaging and evaluation of pulmonary embolism when paired with perfusion imaging.

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, the acceptable surface limit (ASL), and the Permitted Daily Exposure (PDE) 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 Pentetic Acid, just click the ADD TO CART button.

HBEL

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