| Parameter |
Specification |
Unit |
Organoleptic test |
| Appearance |
white powder |
|
Physical parameter |
| Loss on drying |
≤ 2,0 |
% |
| Loss on ignition |
6,6 – 8,5 |
% |
| Bulk density |
800 – 1000 |
g/l |
Identity |
| Assay |
CaHPO4 98,0 – 102,0 |
% |
| Assay |
Microbiological purity ≤ 1000 |
cfu/g |
| Identification |
A, B: complies |
|
Impurities |
| Heavy Metals (as Pb) |
≤ 15 |
ppm |
| Insoluble impurities |
in acid ≤ 0,2 |
% |
| Sulphates (SO4) |
≤ 0,5 |
% |
| Impurity |
Carbonates: complies |
% |
| Impurity |
Fluoride ≤ 50 |
ppm |
| Impurity |
Mono- u. Tricalcium phosphate 14,0 – 15,5 |
ml |
Residual Solvents |
| Residual solvents |
The product does not contain any residual solvents (Class 1, 2 and 3) according to ICH Q3C. The product contains only water as a solvent. |
Elemental Impurities |
| Aluminium (Al) |
≤ 70 |
ppm |
| Arsenic (As) |
≤ 1 |
ppm |
| Barium (Ba) |
passes test |
|
| Cadmium (Cd) |
≤ 1 |
ppm |
| Chlorides (Cl) |
≤ 330 |
ppm |
| Iron (Fe) |
≤ 100 |
ppm |
| Mercury (Hg) |
≤ 1 |
ppm |
| Lead (Pb) |
≤ 1 |
ppm |
Organic volatile impurities |
| Org. volat. Imp. Total |
complies |
|
Microbiological data |
| Yeast and Mould |
≤ 1000 |
CFU/g |
Particle size distribution |
| Particles |
< 325 Mesh ≥ 99,0 |
% |
Regulatory information:
Allergens statement:
The product does not contain any allergens according to Regulation (EU) No. 1169/2011, Annex II and its amendment (EU) No. 78/2014.
BSE/TSE statement:
A risk of contamination with BSE/TSE can be excluded
Ethylene Oxide (EtO) Statement:
The presence of ETO is unlikely.
GMO statement:
The product does not contain or consist of GMOs and there is no obligation for labelling as defined by the Regulations (EC) No. 1829/2003 and 1830/2003.
Irradiated Status:
The product is not treated with irradiation during the production process, packaging and/or storage.
Nanoparticles:
The product does not contain nanomaterial acc. to the definition of Regulation (EU) 2015/2283 article 3 (2)(f).
Supplemental information:
Shelf life:
3 years
Note:
Nutritional information: inorganic substance without nutritional values
The product does not come into contact with substances on the current World Anti-Doping Agency (WADA) Prohibited List during the production process, packaging and storage. These substances are neither produced nor handled at the production site.
The product does not contain any palm-based ingredients.
Storage conditions:
Store in original packaging tightly closed in a cool, dry, well-ventilated place
Packing:
Meets the requirements of the Regulations 10/2011/EU, 1935/2004/EC and 2023/2006/EC.
Usage:
The product is suitable for a vegetarian nutrition.The product is suitable for a vegan nutrition.The product is in compliance with Jewish dietary laws.The product is in compliance with Islamic dietary laws.
