TriNutra receives USP monograph distinction for proprietary Black Seed Oil

Published: 13-Feb-2023
Ingredients Regulatory

Monograph will ensure black seed oil meets critical standards of strength, purity, and quality

TriNutra, the supplier of the first cold-pressed, full spectrum, black seed oil standardised to 3% thymoquinone, has announced their ingredient ThymoQuin has met the US Pharmacopeia – National Formulary (USP-NF) standard, further validating its quality.  

The USP standards are globally recognised and followed as the benchmarks measuring only the highest qualities. A monograph is a written document that reflects the quality attributes of dietary supplement as well as medicines approved by the U.S. Food and Drug Administration (US FDA). Some of these attributes include:

  • Identity - Tests to identify that a particular substance is the dietary supplement (DS) composition that it claims to be.
  • Strength – validated testing methods and acceptable ranges for the potency of a DS. For example, this indicates the amount of the actives in a DS product.
  • Purity - Information on impurities that may be present and the amounts of these that are permitted, along with validated testing methods to identify and measure them. An impurity is any component in the DS raw material or finished dosage form, which is not the desired product, and may present safety concerns.

“With the traction the black seed oil market has right now, and the recent adulteration report Published by ABC-AHP-NCNPR Botanical Adulterants Prevention Program, it is imperative that a better-quality standard be in place,” said Morris Zelkha, CEO of TriNutra. 

This monograph covers the full-spectrum black seed oil standardisation, which includes: 

  • Thymoquinone minimum of 3% 
  • P-cymene minimum of 1% (to prevent adulteration)
  • Carvacrol no more than 0.1%, 
  • Acid Value no more than 2.5% 
  • Fatty acid profile
  • Other identifications such as ash content, iodine number, etc

“This USP monograph is just the first step in strengthening the quality of black seed oils across the industry,” said Chris Holland, VP Sales at Barrington Nutritionals. “I am encouraged by TriNutra’s pioneering work in providing the consumer an extra layer of quality assurance when selecting a product to buy.”

  • Companies:
  • Barrington Nutritionals
  • TriNutra
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