OEL Fastrac Catalog

Galactose (also known as D-galactose) belongs to the class of organic compounds known as hexoses. Galactose differs from glucose only by the configuration of the hydroxyl group at the carbon-4 position. Often present as an anomeric mixture of α-D-galactose and β-Dgalactose, this monosaccharide exists abundantly in milk, dairy products and many other food types such as fruits and vegetables. Other sources of galactose include endogenous production and natural turnover of glycolipids and glycoproteins. Galactose is used as an ultrasound contrast medium to enhance ultrasound imaging of the female genital tract, and suspensions of galactose, with palmitic acid have been used in echocardiography. The clearance of galactose given intravenously has been used as a measure of liver function. Galactose labeled with carbon-13 has also been used.

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 Galactose, just click the ADD TO CART button.

HBEL

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