Market Updates

USP Publishes Monograph for Palm Oil Tocotrienols and Tocopherols

The monograph will help product manufacturers test these ingredients in a validated way, and contains quality acceptance standards and criteria.

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By: Mike Montemarano

The United States Pharmacopoeia (USP) has published a monograph on palm oil tocotrienols and tocopherols under the category of non-botanical dietary supplements. Tocotrienols and tocopherols are two groups of compounds which make up the vitamin E family.
 
The USP National Formulary is recognized as an official compendium of the United States by the Federal Food, Drug, and Cosmetic Act, and USP’s monographs are publicly available for use by regulators, public health authorities, and dietary supplement companies to verify quality expectations and standards of an ingredient or product.
 
The USP Monograph defines the products it covers and specifies the labelling, packaging and storage standards that must be met by each product. The specification is made up of acceptance criteria, evaluation procedures and validated tests. In general, USP Monograph sets the standard in the industry for a particular product or ingredient vis a vis quality, strength, purity and safety.
 
“I was personally involved in this journey of setting up the monograph. As such, I am very pleased and grateful that the US-NF Pharmacopeia has recognized the palm oil tocotrienols and tocopherols with this official USP-NF monograph,” said Bryan See, vice president of Phytogaia, a supplier of palm tocotrienols and tocopherols.  “This monograph clearly established the gold standard for palm oil tocotrienols and tocopherols in the industry in providing official testing guidelines for the identification, strength, quality, safety and purity of a palm oil tocotrienols and tocopherols product.”
 
 Based on the USP Monograph, Palm Oil Tocotrienols and Tocopherols consist mainly of a mixture of α-, β-, γ-, and δ-tocotrienols and α-tocopherol derived from the oil from the mesocarp of fruits of Elaeis guineensis Jacq. (Family Arecaceae). β-, γ- and δ-tocopherols may be present in minor amounts. It also consists of phytosterols and squalene, which are naturally present in palm oil.
 
“For nutraceuticals companies in particular, the USP-NF monograph is the most comprehensive source for ingredient or product quality standards,” said Dr. Ariati Aris, scientific affairs specialist at PhytoGaia. “USP is committed to increasing the confidence in the industry as well as safeguarding of public safety and health. We are delighted that USP-NF has developed and published this monograph for palm oil tocotrienols and tocopherols, which will be beneficial in ensuring the quality of dietary supplements with tocotrienols.”
 
 

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