| Parameter |
Specification |
Unit |
Organoleptic test |
| Appearance |
Phytomenadione 1%, matrix of glucose syrup, gum arabic and tricalcium phosphate, free flowing light yellow powder that consists of almost spherical particles or agglomerates |
Physical parameter |
| Loss on drying |
(gravimetric; 105°C): ≤ 5 |
% |
Identity |
| Assay |
Vitamin K1 (HPLC): ≥ 1,00 |
% |
Impurities |
| Heavy Metals (as Pb) |
* ≤ 10 |
mg/kg |
Elemental Impurities |
| Arsenic (As) |
* ≤ 1 |
mg/kg |
| Cadmium (Cd) |
* ≤ 0,5 |
mg/kg |
| Mercury (Hg) |
* ≤ 0,1 |
mg/kg |
| Lead (Pb) |
* ≤ 0,5 |
mg/kg |
Microbiological data |
| Escherichia Coli. |
not detectable in 1 g |
| Salmonella |
not detectable in 25 g |
| Total Plate Count |
Total viable aerobic count: ≤ 1000 |
CFU/g |
| Yeast and Mould |
≤ 200 |
CFU/g |
Particle size distribution |
| Particles |
Through mesh 80 USP: 100 |
% |
Annotation:
* This test is verified on random sampling only
Regulatory information:
Allergens statement:
According to Annex II of Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25th October 2011 and its amendment (EU) No 78/2014 on substances or products the above mentioned product does NOT cause allergies or intolerances and does NOT contain any allergens which have to be labelled according to these regulations.
BSE/TSE statement:
The product does not contain animal ingredients.
The risk of BSE/TSE contamination can be excluded.
GMO statement:
Genetic engineering:
For the above mentioned product there is no obligation of g.m.o. labelling as defined by the Regulations (EC) No 1829/2003 and 1830/2003 of the European Parliament and the Council of 22nd September 2003.
Irradiated Status:
Product has not been treated with ionizing radiation
Supplemental information:
Shelf life:
Stored in the original unopened packaging under appropriate conditions the product is stable for at least 36 months from the date of production.
Derivation:
Source of active substance: synthetic
Source of Matrix: synthetic (tricalcium phosphate), vegetable (glucose syrup, gum arabic)
Note:
Traceability
According to Regulation (EC) No 178/2002 the traceability of the raw materials for the product is guaranteed one step backwards and of produced batches one step forward. All instructions, which are necessary to take these steps, are implemented in the Quality manual and management system according to IFS and BRC.
The product contains no palm-based components
Storage conditions:
Protect from light and store cool and dry in well-closed original packaging. The temperature should not exceed 25 °C.
Packing:
The primary packaging of the above-mentioned product is suitable for food
Usage:
The product is suitable for a vegetarian nutrition.
The product is suitable for a vegan nutrition.
The product is suitable for lactose intolerance diet.
The product is suitable for people with coeliac disease and sprue.
The product is in compliance with Jewish dietary laws.
The product is in compliance with Islamic dietary laws.
