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.
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:
To order an OEL/ADE monograph for Withania somnifera Extract, just click the ADD TO CART button.
If you're wondering about HBEL, we have something for you.
Not the compound you were looking for? You can search the OEL Fastrac catalog to find more available compounds.
Affygility Solutions’ OEL Fastrac service is an user-friendly system that enables us to make confident decisions and focus on moving the compound safely through our facility. We can quickly access the database to determine if a new drug is within the OEL Fastrac library, and if so, immediately download a detailed OEL banding report. The OEL Fastrac system has been a helpful tool in our overall EH&S program.