| Assay (acidimetric; calculated on dried substance) |
99.5 - 101.0 % |
| Identity |
passes test |
| Appearance of solution |
passes test |
| pH-value (5 %; water) |
≤ 8.6 |
| Carbonate |
passes test |
| Carbonate (as potassium carbonate) |
≤ 2.5 % |
| Chloride (Cl) |
≤ 0.007 % |
| Sulfate (SO₄) |
≤ 0.01 % |
| Heavy metals (as Pb) |
≤ 0.0005 % |
| As (Arsenic) |
≤ 0.0002 % |
| Ca (Calcium) |
≤ 0.005 % |
| Fe (Iron) |
≤ 0.001 % |
| Hg (Mercury)* |
≤ 0,00003 |
| Na (Sodium) |
≤ 0.03 % |
| NH₄ (Ammonium) |
≤ 0.002 % |
| Pb (Lead) |
≤ 0.0002 % |
| Si (Silicon) |
≤ 0.03 % |
| Residual solvents (ICH Q3C) |
excluded by manufacturing process |
| Loss on drying (Silica gel) |
≤ 0.25 % |
| 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, FCC, E 501Conforms to the purity criteria on food additives according to the current European Commission Regulation. |
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