Hawthorn (Crataegus spp.) belongs to the Rosaceae family, with about 280 species present in Europe, North Africa, West Asia, and North America. It contains a minimum of 1.5% of total flavonoids, expressed as hyperoside. The fruits contain primarily procyanidins and triterpene acids and are used in jams, wine and confections. The main constituents of the hawthorn leaves and flowers include flavonoids (flavones and flavonoles) mainly in form of glycosides (e.g., vitexin, vitexin-2’’-rhamnoside, isovitexin, hyperoside, quercetin), flavan compounds (e.g., (+)-catechin, (-)-epicatechin, oligo- and polymeric procyanidins), triterpenic acids (e.g., crataegolic acid, urolic acid, oleanic acid), amines (e.g., phenethylamine, acetylcholine, ethylamine), organic acids (e.g., caffeic acid, chlorogenic acid) and other constituents (e.g., purine derivatives, minerals).
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, an 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:
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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.