OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to 90028-20-9 (Echinacea purpurea extract), 97281-15-7 (Echinacea pallida extract), and 129677-89-0 (Echinacea angustifolia tincture). Echinacea species are perennials that are closely related to sunflowers, daisies, and ragweed. They are indigenous to the area east of the Rocky Mountains in the United States (US) but are now cultivated for medicinal use in the western US, Canada, and Europe. Echinacea purpurea (L.) Moench radix, Echinacea angustifolia DC. radix and Echinacea pallida (Nutt.) Nutt. (Asteraceae) are frequently used as medicinal plants. The aerial parts of Echinacea purpurea are used, as well as the whole plant including the roots from all three species. Constituents of Echinacea angustifolia radix contains not less than 0.5% of echinacoside. Constituents of Echinacea purpurea radix contain not less than 0.5% for the sum of caftaric acid and cichoric acid in the dried drug. Polysaccharides, glycoproteins, caffeic acid derivatives and alkamides have been considered as the constituents that are most relevant for echinacea activity. Alkamides contained in the echinacea dry extract (0.01-0.7%) are mainly isobutylamides of straight-chain fatty-acids with olefinic and/or acetylenic bonds, isomeric dodeca-2E,4E,8Z,10E/Z-tetraenoic isobutylamide. Undeca-2Z,4E-diene-8,10-diynoic acid isobutylamide is also prominent. Isobutylamides contain mainly 2,4-dienoic units.

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 Echinacea Extract, just click the ADD TO CART button.

HBEL

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