OEL Fastrac Catalog

Gallium is a rare, silvery (usually trivalent) metallic element. Gallium can be used to detect such diseases as Hodgkin’s disease, lymphomas, and interstitial lung disease. Gallium nitrate is also used as an anticancer drug for lymphomas and bones. It can reverse bone degeneration and/or hypercalcemia cancer, osteoporosis, and Paget’s syndrome. In the case of therapeutic action, gallium halts bone resorption, normalizes serum calcium levels, adds bone mass, and kills cancer cells. Some gallium drugs become acute renal toxins at 10 to 100 times the therapeutic dose. Gallium does not accumulate in tissues, nor does it cause mutations or show other signs of toxicity. In dental applications, gallium alloys are nonstaining and used in the fabrication and repair of dental prostheses. These alloys exhibit a sufficiently high solder temperature, enabling pre-soldering of the alloy without distortion of the restoration.

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 Gallium, just click the ADD TO CART button.

HBEL

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