ChromaDex Corp. (Irvine, CA) and American Laboratories, Inc. (ALI, Omaha, NE) has announced the release of a Fourier Transform Near Infrared (FT-NIR) based identification method for the positive identification of desiccated bovine and porcine glandular tissues used in nutritional product formulations.
ChromaDex has developed a FT-NIR algorithm and cluster based analysis model under its ComplyID program to individually identify eighteen bovine and porcine glands provided by ALI. The ComplyID model has the ability to find unique spectral differences with each of the 18 glandular materials for proper identification and verification of glandular material.
ChromaDex’s ComplyID program is designed to help dietary supplement companies meet the minimum identity testing requirements under the FDA’s Dietary Supplement Current Good Manufacturing Practice (cGMP) Rule FDA (U.S. Food and Drug Administration) 21 CFR Part 111.
Frank Jaksch, Jr., CEO and co-founder of ChromaDex, commented, “Compliance with the FDA 21 CFR part 111, the Dietary Supplement cGMPs, continues to be a critical issue for the industry. Staying in compliance is an ongoing effort for all companies because interpretation and enforcement continues to evolve. Many companies have been surprised to find that their initial quality systems are no longer adequate in today’s regulatory climate. We are pleased to collaborate with ALI to provide the industry with an identity test for glandular related ingredients.”