| Assay (argentometric; calculated on dried substance) |
99.0 - 100.5 % |
| Identity |
passes test |
| Appearance of solution |
passes test |
| Appearance of solution (JP) |
passes test |
| Alkaline impurities |
passes test |
| Chloride, Bromide and Thiosulfate |
passes test |
| Cyanide (CN) |
passes test |
| Iodate(IO₃) |
passes test |
| Sulfate (SO₄) |
≤ 0.005 % |
| Thiosulfate (S₂O₃) |
passes test |
| Thiosulfate and barium |
passes test |
| Total nitrogen (N) |
≤ 0.001 % |
| Heavy metals (as Pb) |
≤ 0.001 % |
| As (Arsenic) |
≤ 0.0005 % |
| Fe (Iron) |
≤ 0.0002 % |
| Na (sodium) |
passes test |
| Residual solvents (Ph Eur/USP/ICH) class 3 |
≤ 0.1 % |
| Other residual solvents (Ph Eur/USP/ICH) |
excluded by manufacturing process |
| Loss on Drying (105°C) |
≤ 0.5 % |
| 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, JP, USP |
|
