| Assay (argentometric; calculated on dried substance) |
98.0 - 100.5 % |
| Identity |
passes test |
| Appearance of solution (10 %; water) |
passes test |
| Acidity or alkalinity |
passes test |
| Heavy metals (as Pb) |
≤ 0.001 % |
| As (Arsenic) |
≤ 0.0003 % |
| Pb (Lead) |
≤ 0.0002 % |
| Ammonium, volatile amines |
passes test |
| Ammonium, primary amines |
passes test |
| 1,4 Dioxane |
passes test |
| Residual solvents (ICH Q3C) |
excluded by the manufacturing process |
| Residue on ignition |
≤ 0.05 % |
| Loss on drying (120 °C) |
≤ 1.5 % |
| Water |
≤ 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 (*). |
|
| Corresponds to DAB 10, FCC |
|