Arnica species are herbaceous perennial plants native to the mountains of the Alps, Pyrenees, Balkan Mountains, Scandinavia, the Baltic states, mountain areas of Canada and the northern Unites States. The species accepted for medicinal use is Arnica montana. The herbal substance consists of the dried flower heads of Arnica montana. The minimum content of sesquiterpene lactones according to the European Pharmacopeia (Ph. Eur.) is 0.4%. The most relevant constituents of Arnica montana are helenalin and plenolin and their derivatives. The content varies with respect to the geographical origin. More recent investigations led to the detection of methylated flavonoids and further sesquiterpene lactones. The natural variability of sesquiterpene lactones in the herbal substance is 0.3 to 1.0%. Other natural constituents of Arnica montana are flavonoids (0.4 to 0.6%), essential oil (0.2 to 0.35%) and mono- and sesquiterpenes.
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), as well as PIC/S and ANVISA requirements, 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.