OEL Fastrac Catalog

Withania somnifera, also known as ashwagandha, winter cherry or Indian ginseng, is a medicinal plant that belongs to the Solanaceae family and has been widely used in Ayurvedic medicine. It is mainly found growing in Africa, the Mediterranean region and India. The roots of Withania somnifera are the main parts used for therapeutical purposes. Historically, the herb has been used in traditional medicine systems for the treatment and prevention of many conditions. Trials that support its clinical use are limited; however, studies carried out with animals and in vitro tests suggest its effects on the immune system, endocrine system, central nervous system (CNS) and on inflammatory conditions.

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 Withania somnifera Extract, just click the ADD TO CART button.

HBEL

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