OEL Fastrac Catalog

Urea carbon-13 (also referred to as urea 13C, urea C-13, urea 13C, urea C13, and 13C-urea, among others) is a urea molecule radiolabeled with the nonradioactive element carbon-13. It is used for the urea breath test (UBT) as a diagnostic agent used for the detection of urease associated with Helicobacter pylori in the human stomach and for initial diagnosis or posttreatment monitoring of Helicobacter pylori infection in adults. Radiolabeled urea is available in two forms; 13C and 14C. Both forms can be used within the UBT; however, 13C is preferred, as it is nonradioactive compared to 14C, which may be preferable in pregnant women and children.

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 Urea Carbon-13, just click the ADD TO CART button.

HBEL

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