| Identity |
passes test |
| Assay (alkalimetric, calculated on calcined substance) |
≥ 93.5 % |
| Free alkali (as NaOH) |
≤ 2.5 % |
| In water insoluble matter (calculated on dried substance) |
≤ 0.2 % |
| pH-value (1 %, water) |
11.5 - 12.5 |
| Fluoride (F) |
≤ 0.0010 % |
| Heavy metals (as Pb) |
≤ 0.0010 % |
| As (Arsenic) |
≤ 0.00005 % |
| Cd (Cadmium) |
≤ 0.0001 % |
| Hg (Mercury) |
≤ 0.0001 % |
| Pb (Lead) |
≤ 0.0001 % |
| Loss on ignition (800 °C) |
45.0 - 57.0 % |
| Residual solvents (ICH Q3C) |
excluded by production process |
| 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 NF, E 339Conforms to the purity criteria on food additives according to the current European Commission Regulation. |
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