| Assay (alkalimetric, calculated on dried substance) |
98.0 - 100.5 % |
| Assay (alkalimetric; dried substance) |
98.0 - 101.0 % |
| Identity |
passes test |
| Appearance of solution |
passes test |
| In water insoluble matter (calculated on dried substance) |
≤ 0.15 % |
| pH-value (1 %, water) |
4.1 - 4.7 |
| pH-value (5 %; water) |
4.2 - 4.5 |
| pH-value (5.7 %; water) |
4.1 - 4.5 |
| Chloride (Cl) |
≤ 0.005 % |
| Fluoride (F) |
≤ 0.001 % |
| Hydrogenphosphate (HPO₄) |
≤ 0.5 % |
| Sulfate (SO₄) |
≤ 0.01 % |
| Heavy metals (as Pb) |
≤ 0.0005 % |
| Al, Ca and other elements detectable with ammonia |
passes test |
| As (Arsenic) |
≤ 0.0001 % |
| Cd (Cadmium) |
≤ 0.0001 % |
| Fe (Iron) |
≤ 0.001 % |
| Hg (Mercury) |
≤ 0.0001 % |
| Pb (Lead) |
≤ 0.0001 % |
| Substances reducing potassium permanganate (as O) |
passes test |
| Residual solvents (ICH Q3C) |
excluded by production process |
| Loss on drying (130 °C) |
22.0 - 24.0 % |
| 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, USP, JPE, E 339 Conforms to the purity criteria on food additives according to the current European Commission Regulation. |
|
