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MK7 STANDARD REFERENCE
Gnosis offers a vitamin K2 in compliance with USP and TGA REQUIREMENTS to its business partners and customers, in a global market where different sources and quality of menaquinone-7 coexist.
VitaMK7®, exclusively manufactured by Gnosis, is the "real natural" active isomer of Vitamin K2, increasing strength in global markets and achieving results and new markets.
VitaMK7® has got another greater validation since it became the USP Standard Reference: vitaMK7® is produced under the most stringent cGMP procedures and it is used for all quality control analyses required for the Monograph.
The first Official Compendia Monograph of Dietary Supplement for Vitamin K2 as Menaquinone-7 (MK-7), published in USP 38-NF33 First Supplement, effective from August 1st, 2015, defines high quality standards for an optimal Vitamin K2 ingredient, made up of Bacillus subtilis natto extract of Menaquinone-7.
The United States Pharmacopeial Convention issued three specific Monographs:
- Bacillus subtilis sub. Subtilis Menaquinone extract
- Menaquinone-7 Preparation
This is a real milestone because it has been created an established USP monograph recognized for Vitamin K2 as MK7 that makes available a unified reference for the industry to accurately identify the product in question.
On the same topic, in August 2015, the Australian Health Authority - TGA (Therapeutic Goods Administration) published a note recognizing that the USP Menaquinone-7 provides the guidance of the quality expected for Vitamin K2 products.
Driven by the need to guarantee extremely high quality standards for an optimal Vitamin K2 ingredient for its business partners and customers in a global market where different sources and quality 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, favorably acknowledged the application and began an exchange of information with Gnosis in order to adapt the draft monograph as a model for the most advanced quality standards of Vitamin K2.
Gnosis solely contributed to the preparation of the above monographs working closely with different teams at USP and is already supplying USP with the Vitamin K2 Standard Reference.