OEL Fastrac Catalog

Please note, this monograph also contains the pediatric ADE. The extract of the ginkgo leaves contains flavonoid glycosides and terpenoids (ginkgolides, bilobalides) and has been used pharmaceutically for hundreds of years. It has many alleged nootropic properties, and is mainly used as memory and concentration enhancer, and antivertigo agent. Ginkgo extract seems to have three effects on the human body. It improves blood flow (including microcirculation in small capillaries) to most tissues and organs. It protects against oxidative cell damage from free radicals. It also blocks many of the effects of the platelet-activating factor, (PAF) such as platelet aggregation and blood clotting, that have been related to the development of a number of cardiovascular, renal, respiratory and central nervous system (CNS) disorders.

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.

Please note: Due to the complexity and amount of studies regarding this compound—a Natural Health Product—increased cost is charged.

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 Ginkgo Biloba, just click the ADD TO CART button.

HBEL

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