| Assay according to Ph Eur/BP (argentometric; calculated on driedsubstance) |
99.0 - 100.5 % |
| Assay according to USP (argentometric; calculated on dried substance) |
99.0 - 100.5 % |
| Assay according to JP (argentometric; calculated on dried substance) |
99.0 - 100.5 % |
| Identity |
passes test |
| Appearance of solution |
passes test |
| Alkalinity |
passes test |
| Acidic or alkaline impurities |
passes test |
| Bromate(BrO₃) |
passes test |
| Chloride (Cl) |
≤ 0.2 % |
| Iodide (I) |
passes test |
| Sulfate (SO₄) |
≤ 0.005 % |
| Heavy metals (as Pb) |
≤ 0.001 % |
| As (Arsenic) |
≤ 0.0002 % |
| Ba (Barium) |
passes test |
| Ca (Calcium) |
≤ 0.005 % |
| Fe (Iron) |
≤ 0.001 % |
| Mg (Magnesium) |
≤ 0.002 % |
| Magnesium and alkaline-earth metals (as Ca) |
≤ 0.02 % |
| Residual solvents (Ph Eur/ICH) |
excluded by manufacturing process |
| Loss on drying (110 °C) |
≤ 3.0 % |
| 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 (*). |
|
| Conforms to Ph Eur, BP, USP, JP |
|
