| Assay (calculated on dried substance according to Ph Eur) |
98.0 - 101.0 % |
| Assay (calculated on dried substance according to USP) |
98.0 - 100.5 % |
| Assay (acidimetric; dried substance) |
99.0 - 101.0 % |
| Identity |
passes test |
| Appearance of solution |
passes test |
| In water insoluble matter (calculated on dried substance) |
≤ 0.20 % |
| Sodium dihydrogen phosphate (NaH₂PO₄) |
≤ 1.7 % |
| pH-value (1 %, water) |
9.0 - 9.4 |
| Carbonate |
passes test |
| Chloride (Cl) |
≤ 0.01 % |
| Fluoride (F) |
≤ 0.001 % |
| Sulfate (SO₄) |
≤ 0.03 % |
| Heavy metals (as Pb) |
≤ 0.001 % |
| As (Arsenic) |
≤ 0.0001 % |
| Cd (Cadmium) |
≤ 0.0001 % |
| Fe (Iron) |
≤ 0.002 % |
| Hg (Mercury) |
≤ 0.0001 % |
| Ni (Nickel)* |
≤ 0.0002 |
| Pb (Lead) |
≤ 0.0001 % |
| Residual solvents (ICH Q3C) |
excluded by production process |
| Substances reducing potassium permanganate |
passes test |
| Loss on drying (130 °C) |
≤ 1.0 % |
| Particle size (< 0.315 mm) |
about 99 % |
| 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. |
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