OEL Fastrac Catalog

Ioversol is an iodine containing radiographic contrast agent indicated for cerebral, peripheral, visceral, renal and coronary arteriography, CT imaging of the head and body, venography and intravenous excretory urography and intravenous digital subtraction angiography. Ioversol is an organoiodine compound used as a diagnostic contrast medium. It features both a high iodine content, as well as several hydrophilic groups. Intravascular injection of ioversol opacifies vessels in the path of the flow of the contrast medium, permitting radiographic visualization of the internal structures until significant hemodilution occurs. In imaging of the body, iodinated contrast agents diffuse from the vascular into the extravascular space. In a normal brain with an intact blood-brain barrier, contrast does not diffuse into the extravascular space. In patients with a disrupted blood-brain barrier, contrast agent accumulates in the interstitial space in the region of disruption.

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 Ioversol, just click the ADD TO CART button.

HBEL

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