Prunus africana (Hook f.) Kalkm. (also known as Pygeum africanum Hook f.) belongs to the Rosaceae family. Pygeum africanum bark consists of the whole or cut, dried bark of the stems and branches of Prunus africana (Hook f.) Kalkm. The main constituents are phytosterols found at approximately 0.05% (e.g., beta-sitosterol, beta-sitosterol 3-glucoside and betasitostenone), free C, C24 fatty acids. Pentacyclic triterpenic acids are present at 14%, (ursolic and oleanolic acid derivatives) as well as long-chain aliphatic alcohols (n-docosanol, n-tetracosanol and their trans-ferulic acid esters). The proposed active constituents of a lipophilic extract of Prunus africana cortex include docosanol (0.6%) and beta-sitosterol (15.7%). Other major constituents include alkanols (tetracosanol (0.5%) and trans-ferulic acid esters of docosanol and tetracosanol), fatty acids (which are 12 - 24 carbons in length, 62.3%, comprising myristic, palmitic, linoleic, oleic, stearic, arachidic, behenic and lignoceric acids); sterols (sitosterone (2.0%) and daucosterol) and triterpenes (ursolic acid (2.9%), friedelin, cortex (1.4%), 2-a-hydroxyursolic acid (0.5%), epimaslinic acid (0.8%) and maslinic acid). Tannins have also been found in the plant.
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.
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.