| Parameter |
Specification |
Unit |
Organoleptic test |
| Appearance |
dry formulation vitamin K 1 on a matrix of glucose syrup free-flowing, light yellow powder, consisting of almost spherical particles or agglomerates |
Physical parameter |
| Loss on drying |
(105 °C) ≤ 5 |
% |
| Bulk density |
≤ 0,6 |
g/ml |
| Solubility |
forms a relatively stable milky emulsion in water at 10°C |
Identity |
| Assay |
≥ 5.00 |
% |
Impurities |
| Heavy Metals (as Pb) |
Größenverteilung 80 mesh (Sieben): ≤ 10 |
ppm |
Elemental Impurities |
| Arsenic (As) |
based on random sampling ≤ 1 |
ppm |
| Cadmium (Cd) |
≤ 1 |
ppm |
| Mercury (Hg) |
based on random sampling ≤ 0,1 |
ppm |
| Lead (Pb) |
≤ 2 |
ppm |
Microbiological data |
| Escherichia Coli. |
not detectable in 1 g |
CFU/g |
| Salmonella |
not detectable in 25 g |
| Total Plate Count |
≤ 1000 |
CFU/g |
| Yeast and Mould |
≤ 200 |
CFU/g |
Particle size distribution |
| Particles |
80 mesh: ≥ 100 |
% |
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:
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:
Non-irradiated
Supplemental information:
Shelf life:
36 month
Derivation:
synthetic
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.
Storage conditions:
Protect from light and store cool and dry in well-closed original packaging. The temperature should not exceed 25 °C.
Usage:
food grade
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.
