OEL Fastrac Catalog

Resveratrol is a phytoalexin derived from grapes and other food products with antioxidant and potential chemopreventive activities. Resveratrol is most commonly used for high cholesterol, cancer, heart disease, and many other conditions. However, there is not strong evidence to support the use of resveratrol for these uses. Resveratrol is being investigated for the treatment of herpes labialis infections (cold sores). Resveratrol is available as dietary supplements from red wine extracts, grape seed extracts and Japanese knotweed extracts among others. Most supplements on the market are derived from Japanese knotweed because this plant has one of the highest concentrations of resveratrol found in nature. Resveratrol is also available in solution form and as a transdermal patch. Resveratrol is considered a dietary supplement and its safety and effectiveness have not been approved by the United States Food and Drug Administration.

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 Resveratrol, just click the ADD TO CART button.

HBEL

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