| Assay (acidimetric, Na₂CO₃) |
36.7 - 40.0 % |
| Assay (acidimetric; calculated on dried substance) |
≥ 99.0 % |
| Identity |
passes test |
| Appearance of solution |
passes test |
| Alkali hydroxides and Alkali hydrogen carbonates |
passes test |
| Chloride (Cl) |
≤ 0.0050 % |
| Sulfate (SO₄) |
≤ 0.0100 % |
| Heavy metals (as Pb) |
≤ 0.0020 % |
| As (Arsenic) |
≤ 0.0002 % |
| Cu (Copper) |
≤ 0.0025 % |
| Fe (Iron) |
≤ 0.0020 % |
| Hg (Mercury) |
≤ 0.0001 % |
| Pb (Lead) |
≤ 0.0002 % |
| Zn (Zinc) |
≤ 0.0025 % |
| Residual solvents (ICH Q3C) |
excluded by manufacturing process |
| Loss on drying (300 °C) |
55.0 - 65.0 % |
| 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 500 Conforms to the purity criteria on food additives according to the current European Commission Regulation. |
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