Pygeum

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.

Pygeum

CAS Registry Number:
94279-95-5
Cost:
$639 USD

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Why do you need this OEL Fastrac monograph?

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:

  • The numerical OEL and control band assignment needed to determine the level of required engineering controls and personal protective equipment
  • A listing of all cited references utilized in the derivation of the OEL and ADE
  • An expert review and discussion with respect to the critical endpoints of concern, the rationale for the choice of endpoints, and dose that is to be used in the derivation of the ADE (PDE), as required by the EMA's Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities

Benefits of OEL Fastrac monographs

  • Fully documented. 10-12 pages in length, with calculations and cited references.
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To order an OEL/ADE monograph for Pygeum, just click the ADD TO CART button.

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  • K. Rosenthal
  • Director of Manufacturing
  • Pharmatek Laboratories