| Assay (precipitative titration, calculated on dried substance) |
98.5 - 100.5 % |
| Identity |
passes test |
| Appearance of solution |
clear and colourless |
| Alkalinity (as NaOH) |
≤ 0.1 % |
| Acidity (as HF) |
≤ 0.2 % |
| Chloride (Cl) |
≤ 0.01 % |
| Hexafluorosilicate (SiF₆) |
≤ 0.1 % |
| Sulfate (SO₄) |
≤ 0.02 % |
| Heavy metals (as Pb) |
≤ 0.003 % |
| Fe (Iron) |
≤ 0.005 % |
| Loss on drying (150 °C, 4 h) |
≤ 0.5 % |
| Residual solvents (Ph Eur/USP/ICH) |
Excluded by manufacturing 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 (*). |
|
| conforms to Ph Eur, BP, USP |
|
