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The monograph is now part of The U.S. Pharmacopeia’s (USP) Dietary Supplements Compendium.
A new monograph for vitamin K2 menaquinone-7 (MK7) built around Gnosis’s (Desio, Italy) own VitaMK7 ingredient is now part of The U.S. Pharmacopeia’s (USP) Dietary Supplements Compendium.
Gnosis says that its own teams drafted the monograph proposal, which USP accepted, driven partly by the company’s need “to guarantee extremely high-quality standards for an optimal vitamin K2 ingredient” for its own customers. Gnosis then worked with USP to draft the monograph.
The monograph outlines a vitamin K2 MK7 ingredient containing no organic solvents, as is the case with VitaMK7, which guarantees the absence of solvents thanks to what the company says is its patented production process which uses proprietary supercritical CO2 extraction instead. VitaMK7 is derived through Bacillus subtilis fermentation.
“I am glad that this work has been recognized in the first of a series of USP monographs dedicated to this special vitamin and the role Gnosis had in supplying USP with the vitamin K2 reference standard, which was produced under the most stringent cGMP procedures,” said Marco Berna, Gnosis business development director, in a press release.
Berna and company add that the new monograph has also been accepted by the Australian Health Authority’s Therapeutic Goods Administration (TGA), which will now recognize the USP monograph in the Australian market instead of revising its own compositional guideline for menaquinone.
“This is a significant example of harmonization for the quality standards where a product is able to exceed the current requirements and is accepted by different regulatory bodies,” said Gnosis in a press release. “This recognition helps define a quality vitamin K2 ingredient where no definition of such was previously available, and it will be useful since it sets a clear and uniform assay to measure the active ingredient levels and a standard way to report them so that the consumer can properly compare products.”
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