OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to the additional CAS RN 8008-88-6. Valerian (Valeriana officinalis), a member of the Valerianaceae family (now considered to be a member of the Caprifoliaceae family), is a perennial plant native to Europe and Asia and naturalized in North America. It has a distinctive odor that many find unpleasant. Other names include setwall (English), Valerianae radix (Latin), Baldrianwurzel (German), and phu (Greek). The genus Valeriana includes over 250 species, but V. officinalis is the species most often used in the United States and Europe. Valerian has been used as a medicinal herb since at least the time of ancient Greece and Rome. Its therapeutic uses were described by Hippocrates, and in the 2nd century, Galen prescribed valerian for insomnia. In the 16th century, it was used to treat nervousness, trembling, headaches, and heart palpitations. In the mid-19th century, valerian was considered to be a stimulant that caused some of the same complaints it was thought to treat and was generally held in low esteem as a medicinal herb. During World War II, it was used in England to relieve the stress of air raids. In addition to sleep disorders, valerian has been used for gastrointestinal (GI) spasms and distress, epileptic seizures, and attention deficit hyperactivity disorder. However, scientific evidence is not sufficient to support the use of valerian for these 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.

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.

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HBEL

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