| Parameter |
Test Method |
Specification |
Unit |
Organoleptic test |
| Appearance |
visual |
clear oil |
|
| Colour |
visual |
light yellow |
|
| Odour |
organoleptic |
odourless |
|
Identity |
| Assay |
HPLC |
Menaquinone-7 Content: ≥ 10000 |
ppm |
| Identification |
USP |
1: The retention time of the major peak of the sample solution corresponds to that of the Standard solution. |
| Identification |
USP |
2: Under visible light and short wavelength UV light, the spots from the Sample solution corresponds in color (light yellow), shape, and RF value to those standard solution, after applying for the spray regent, the spots from the sample solution, under white light, correspond in color (dark blue), shape, and RF value to those from the standard solution |
Impurities |
| Impurity |
USP |
Cis-Menaquinone-7 ≤ 2,0 |
% |
| Impurity |
HPLC |
Menaquinone-6 ≤ 1000 |
ppm |
Elemental Impurities |
| Arsenic (As) |
USP 233 |
≤ 2,0 |
ppm |
| Cadmium (Cd) |
USP 233 |
≤ 1,0 |
ppm |
| Mercury (Hg) |
USP 233 |
≤ 0,1 |
ppm |
| Lead (Pb) |
USP 233 |
≤ 3,0 |
ppm |
Microbiological data |
| Escherichia Coli. |
USP 2022 |
absent |
CFU/g |
| Salmonella |
USP 2022 |
absent |
|
| Staphylococcus Aureus |
USP 2022 |
absent |
|
| Total Plate Count |
USP 2021 |
≤ 1000 |
CFU/g |
| Yeast and Mould |
USP 2021 |
≤ 100 |
CFU/g |
Regulatory information:
Allergens statement:
Product is free of allergens according to Regulation (EU) No. 1169/2011 Annex II.
BSE/TSE statement:
Product conforms to TSE/BSE regulation EC Nr. 999/2001.
Ethylene Oxide (EtO) Statement (HACCP):
Meet EC 396/2005
Food Grade Status:
Product is suitable and safe for human consumption according to Regulation EC 178/2002. Product meets the Kosher and Halal Food Conditions.
GMO statement:
Product is GMO free and complies to Regulations (EC) No. 1829/2003 and 1830/2003.
Irradiated Status:
Product is irradiation free according to Directive EC 1992/2/EG and 1169/2011.
Nanoparticles:
In accordance with the definition of the “engineered nanomaterial” of the European regulation 2015/2283 and on our supplier’s information, the product isn’t complying with the definition of “engineered nanomaterials”. So, this raw material, according to the European regulation 1169/2011, isn’t subject to labelling as an engineered nanomaterial.
Vegan Status:
Product is suitable for vegetarian, vegan diets.
Supplemental information:
Shelf life:
2 years from date of manufacture
Note:
Non-Dangerous Product Status: Product does not meet the criteria for classification as dangerous in accordance with EU regulation (EC) No 1272/2008 and its modifications, therefore is not subject to the obligation to provide a Material Safety Data Sheet according to EU regulation (EC) No 1907/2006 and its modifications
Stability and Handling: The product contains compounds susceptible to degradation caused by improper storage or processing influenced by e.g. light, oxygen, heat, pressure. We do not assume responsibility for changes in quality, even during the specified best before date.
Packing:
The packaging of the product conforms to the stipulations set forth in EC Regulation 1935/2004, EC Regulation 10/2011 and EC Regulation 2023/2006
Regional origin:
China
