| Assay Ca (complexometric) |
35.0 - 40.0 % |
| Assay (as Ca₃(PO₄)₂ (calc. o. ignited subst.)) |
≥ 90.2 % |
| Identity |
passes test |
| Substances insoluble in hydrochloric acid |
≤ 0.1 % |
| Carbonate (as CO₂) |
passes test |
| Chloride (Cl) |
≤ 0.1 % |
| Fluoride (F) |
≤ 0.0050 % |
| Sulfate (SO₄) |
≤ 0.5 % |
| Al (Aluminium) |
≤ 0.0200 % |
| As (Arsenic)* |
≤ 0.0001 % |
| Cd (Cadmium)* |
≤ 0.0001 % |
| Fe (Iron) |
≤ 0.0400 % |
| Hg (Mercury) |
≤ 0.0001 % |
| Mg (Magnesium) |
≤ 0.3 % |
| Na (Sodium) |
≤ 0.2 % |
| Pb (Lead)* |
≤ 0.0001 % |
| Si (Silicon) |
≤ 0.05 % |
| V (Vanadium)* |
≤ 0.0010 |
| Heavy metals (as Pb) |
≤ 0.001 % |
| Residual solvents (ICH Q3C) |
excluded by production process |
| Loss on ignition (800 °C) |
≤ 8.0 % |
| Particle size (< 0.063 mm) |
about 98 % |
| Flowability (Hausner Ratio) |
1.3 - 1.6 |
| Bulk density |
0.20 - 0.40 g/ml |
| Compacted bulk density |
0.30 - 0.50 g/ml |
| Elemental impurity specifications have been set considering ICH Q3D (Guideline for Elemental Impurities). Class 1-3 elements are not likely to be present above the ICH Q3D option 1 limit, unless specified and indicated (*). |
|
| Corresponds to Ph Eur, BP, E 341 (iii) Conforms to the purity criteria on food additives, except for use as additive in infant and young child nutrition, according to the current European Commission Regulation. |
|
| Corresponds to Ph Eur, BP, E 341 (iii) Conforms to the purity criteria on food additives, except for use as additive in infant and young child nutrition, according to the current European Commission Regulation. |
|
