| Assay (argentometric; calculated on dried substance) |
99.0 - 100.5 % |
| Assay (argentometric; dried substance) |
99.0 - 101.0 % |
| Identity |
passes test |
| Appearance of solution |
passes test |
| Free acid, free alkali |
passes test |
| Acidity or alkalinity |
passes test |
| Bromide (Br) |
passes test |
|
≤ 0.1 % |
| Bromide, Iodide (Br,I) |
passes test |
| Iodide (I) |
passes test |
|
≤ 0.005 % |
| Sulfate (SO₄) |
≤ 0.01 % |
| Heavy metals (as Pb) |
≤ 0.0005 % |
| Al (Aluminium) |
≤ 0.00010 % |
| As (Arsenic) |
≤ 0.0001 % |
| Ba (Barium) |
passes test |
| Cd (Cadmium) |
≤ 0.0001 % |
| Fe (Iron) |
≤ 0.001 % |
| Hg (Mercury) |
≤ 0.0001 % |
| Na (Sodium) |
≤ 0.05 % |
| Na (sodium) |
passes test |
| Pb (Lead) |
≤ 0.0002 % |
| Ca + Mg (calcium and magnesium) |
passes test |
| Magnesium and alkaline-earth metals (as Ca) |
≤ 0.0200 % |
| Loss on drying (130 °C, 3 h) |
≤ 0.5 % |
| 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 Ph Eur, BP, JP, USP, FCC, E 508Conforms to the purity criteria on food additives according to the current European Commission Regulation. |
|
