| Assay (alkalimetric, calculated on dried substance) |
98.0 - 101.0 % |
| Assay (out of dried substance) |
≥ 98.0 % |
| Identity |
passes test |
| Appearance of solution |
passes test |
| In water insoluble matter |
≤ 0.2 % |
| pH-value (1 %, water) |
8.7 - 9.4 |
| Chloride (Cl) |
≤ 0.02 % |
| Fluoride (F) |
≤ 0.0010 % |
| Sulfate (SO₄) |
≤ 0.1 % |
| Heavy metals (as Pb) |
≤ 0.0010 % |
| Al (Aluminium) |
≤ 0.0005 % |
| As (Arsenic) |
≤ 0.0001 % |
| Cd (Cadmium) |
≤ 0.0001 % |
| Fe (Iron) |
≤ 0.0010 % |
| Hg (Mercury) |
≤ 0.0001 % |
| Na (Sodium) |
≤ 1.5 % |
| Pb (Lead) |
≤ 0.0001 % |
| Potassium dihydrogen phosphate |
≤ 2.5 % |
| Residual solvents (ICH Q3C) |
excluded by manufacturing process |
| Reducing substances |
passes test |
| Loss on drying (130 °C) |
≤ 2.0 % |
| 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 340
Conforms to the purity criteria on food additives according to the current European Commission Regulation. |
