NIST develops multivitamin reference for GMP compliance
The certified reference material, named Standard Reference Material (SRM) 3280 for multivitamin/multimineral tablets, was created in collaboration with the Office of Dietary Supplements (ODS) at the National Institutes of Health (NIH).
A definitive, independently certified standard has been lacking, according to NIST, and the new standard helps fill that gap.
Industry welcome
Daniel Fabricant, PhD, vice president of regulatory and scientific affairs for the trade association the Natural Products Association (NPA), told NutraIngredients-USA.com that such standards can be critical for GMP compliance.
“As it says in the preamble of the GMPs ‘If reference materials and reference standards are used as part of a test or examination method, then such materials and standards are already required to be verified in Sec. 111.60’,” he said.
The reference material is priced currently at $587.00 for 150 tablets in 5 bottles.
Dr Fabricant added that the association is very supportive of the development of the SRMs, and that a number of its member companies volunteer their labs and expertise to the process.
“These materials are a part of the Dietary Supplements Methods and Reference Materials Program at NIH Office of Dietary Supplements, which has overall been very valuable as a means of addressing technical matters with dietary supplement analysis,” added Dr Fabricant.
Formulation
The material was prepared by a multivitamin/multimineral tablet manufacturer as a non-commercial batch of tablets according to their normal procedures. NIST scientists then tested and certified the concentrations of 24 elements and 17 vitamins and carotenoid compounds in the tablets.
“We are not saying what a product should contain, but what it does contain,” said Dr Katherine Sharpless from the NIST’s Analytical Chemistry Division. “Our SRMs are intended for analytical chemists to use to make sure their methods are working properly, not a benchmark for what a good product should be.”
Bigger picture
The standard is part of a larger ongoing effort the NIST group has undertaken to develop reference materials for fatty acids, caffeine, and a whole host of other dietary supplements including ginkgo, saw palmetto, and bitter orange, and others as they appear on store shelves.
According to a National Institutes of Health (NIH) State-of-the-Science Panel, half of the American population routinely use dietary supplements, with their annual spend estimated at over $20 billion.
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