USP acknowledges Gnosis’ proposal for menaquinone-7 monograph

Published: 3-Sep-2015

The company played key role in the definition of a new USP standard requirement for vitamin K2 as menaquinone-7

Gnosis is proud to announce its key role in the definition of a new USP standard requirement for vitamin K2 as menaquinone-7, which will be available in the first official compendial monograph for vitamin K2 as menaquinone-7 (MK-7) as a dietary supplement.

Driven by the need to guarantee extremely high quality standards for a vitamin K2 ingredient for its business partners and customers in a global market, where different sources and qualities of menaquinone-7 coexist, a qualified team of Gnosis experts drafted a vitamin K2 monograph proposal based on the specifications of Gnosis VitaMK7, the real vitamin K2 as MK-7 ... as nature intended.

Gnosis submitted the proposal to the United States Pharmacopeia, who favourably acknowledged the application and began an exchange of information with Gnosis to adapt the draft monograph as a model for the most advanced quality standards of vitamin K2.

Of particular note is the requirement: 'It contains no organic solvents,' which is reported in the definition of the official monograph, and definitively highlights the advantage of a totally natural vitamin K2 as MK7 (VitaMK7), which has been derived from a production process that does not use any solvents.

'Gnosis’ specific process to produce VitaMK7 is patented in EU, USA and Japan,'said Marco Berna, Business Development Director of Gnosis Group, 'and the total absence of solvents is guaranteed by the advanced purification technologies used, which includes extraction by a proprietary supercritical CO2 procedure that allow Gnosis to obtain a product through the natural fermentation of Bacillus subtilis with the highest purity. We have been able to reproduce, on a larger industrial scale, what nature has done for centuries ... but have included a further level of purification and characterisation.'

'I am glad that this work has been recognised 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 and was used for all of the quality control analyses required for the monograph,' he added.

In addition, the Australian Health Authority TGA (Therapeutic Goods Administration) has recently recognised the USP menaquinone-7 monograph for the Australian market. TGA published a note in which it has declared that its proposed revision of the compositional guideline for 'Menaquinone 7' will no longer proceed as the USP-NF monograph for 'Menaquinone-7' provides the relevant guidance of the quality expected.

This is a significant example of harmonisation for the quality standards, where a product is able to exceed the current requirements and is accepted by different regulatory bodies. This recognition helps to define a quality vitamin K2 ingredient where no definition of such was previously available and it will be useful as 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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