| Assay (acidimetric according to Ph Eur) |
99.0 - 101.0 % |
| Assay (acidimetric; calculated on dried substance according to USP) |
99.5 - 100.5 % |
| Assay (acidimetric according to JP) |
99.0 - 101.0 % |
| Identity |
passes test |
| Appearance of solution |
passes test |
| Insoluble matter |
passes test |
| pH-value (1 %, water) |
8.0 - 8.6 |
| pH-value (5 %; water) |
7.9 - 8.4 |
| Carbonate (CO₃) |
passes test |
| Chloride (Cl) |
≤ 0.0150 % |
| Sulfate (SO₄) |
≤ 0.01 % |
| Sulfur compounds (as SO₄) |
≤ 0.015 % |
| Heavy metals (as Pb) |
≤ 0.0005 % |
| Al (Aluminium) |
≤ 0.00005 % |
| As (Arsenic) |
≤ 0.0002 % |
| Ca (Calcium) |
≤ 0.0100 % |
| Cu (Copper) |
≤ 0.0005 % |
| Fe (Iron) |
≤ 0.0020 % |
| Hg (Mercury) |
≤ 0.0001 % |
| NH₄ (Ammonium) |
≤ 0.0020 % |
| NH₄ (Ammonium) according to USP |
≤ 0.0020 % |
| NH₄ (Ammonium) according to JP |
passes test |
| Pb (Lead) |
≤ 0.0002 % |
| Zn (Zinc) |
≤ 0.0025 % |
| Residual solvents (ICH Q3C) |
excluded by production 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, JP, E 500Conforms to the purity criteria on food additives according to the current European Commission Regulation. |
|
