| Assay (argentometric; calculated on dried substance) |
99.5 - 100.5 % |
| Identity |
passes test |
| Appearance of solution |
passes test |
| Acidity or alkalinity |
passes test |
| Bromide (Br) |
≤ 0.005 % |
| Ferrocyanides |
passes test |
| Iodide (I) |
passes test |
| Nitrite (NO₂) (UV-absorption 354nm; 1cm; 10%; water) |
≤ 0.01 |
| Phosphate (PO₄) |
≤ 0.0025 % |
| Sulphate (SO₄) |
≤ 0.0200 % |
| Heavy metals (as Pb) |
≤ 0.0003 % |
| Al (Aluminium) |
≤ 0.00002 % |
| As (Arsenic) |
≤ 0.0001 % |
| Ba (Barium) |
passes test |
| Ca (Calcium) |
≤ 0.002 % |
| Fe (Iron) |
≤ 0.0002 % |
| K (Potassium) |
≤ 0.01 % |
| Magnesium and alkaline-earth metals (as Ca) |
≤ 0.0100 % |
| Residual solvents (ICH Q3C) |
excluded by production process |
| Loss on drying (105 °C, 2 h) |
≤ 0.5 % |
| Endotoxins (kinetic turbidimetric test) |
≤ 2.5 I.U./g |
| 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 |
|
