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.
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), and to obtain the following information:
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Affygility Solutions’s 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.