Pharmaceutical Regulatory Affairs: Open Access

New Max Industry, Brazil

Publications

• Review   
  Risk Assessment of Tocotrienols from Annatto (Bixa orellana L.): Regulatory Contributions
  Author(s): Talita da Silva Ferreira*, Paulo Roberto Nogueira Carvalho and André Limonta Carvalho
  
  Tocotrienols are found naturally in several plant sources, mainly in grains and oils, such as wheat germ, soybean oil, barley, oats, and olive oil. However, these sources have much lower concentrations of tocotrienols. Higher concentrations of tocotrienols are found in Annatto (Bixa orellana L.) seeds. The monograph Dietary Supplement Compendium (DSC) from the United States Pharmacopeia for Annatto Seed Oil Tocotrienols defines that tocotrienols fraction must contain at least 70% of total tocotrienols, calculated on an anhydrous basis of the total tocotrienol content, it must contain between 84% and 92% of δ-Tocotrienol and between 8% and 16% of γ-tocotrienol. The risk assessment with NaturalMax Annatto Tocotrienol™ Oil 70%, extracted from annatto seeds, provided 100% tocotrienols (gamma and delta-tocotrienol) less than 1% α-to.. Read More»
  DOI: 10.37421/2167-7689.2021.10.262

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