Hops are the flowers (also called seed cones or strobiles) of the hop plant, Humulus lupulus, a member of the Cannabaceae family of flowering plants. Hops consist mainly of prenylated phloroglucinol derivatives known as alfa-acids or humulones (2 - 12% of dried strobile), principally humulone (35 - 70%), and beta-acids or lupulones (1 - 10% of dried strobile), principally lupulone (30 - 55%). They also contain flavonoids (0.5 - 1.5%) including quercetin and kaempferol glycosides and at least 22 prenylated or geranylated flavonoids, notably the chalcones xanthohumol (up to 1% of the dried strobile and 80 - 90% of total flavonoids), desmethylxanthohumol and dehydrocycloxanthohumol and the flavanones isoxanthohumol, 8-prenylnaringenin (25 - 60 mg/kg) and 6-prenylnaringenin. Other constituents include proanthocyanidins (2 - 4%), phenolic acids, proteins (15%), polysaccharides (40 - 50%) and 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.
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:
To order an OEL/ADE monograph for Hop Humulus lupulus Extract, just click the ADD TO CART button.
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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.