| Assay (acidimetric) |
98.5 - 102.5 % |
| Assay (acidimetric; calculated on dried substance) |
98.5 - 100.5 % |
| Assay (acidimetric, calculated on dried substance according to JP) |
98.0 - 101.0 % |
| Identity |
passes test |
| Appearance of solution |
passes test |
| In water insoluble matter |
≤ 0.15 % |
| pH-value (2 %; water) |
9.0 - 9.4 |
| pH-value (5 %; water) |
9.0 - 9.3 |
| Carbonate |
passes test |
| Chloride (Cl) |
≤ 0.001 % |
| Sulfate (SO₄) |
≤ 0.01 % |
| Heavy metals (as Pb) |
≤ 0.0008 % |
| As (Arsenic) |
≤ 0.0001 % |
| Fe (Iron) |
≤ 0.001 % |
| Sodium dihydrogen phosphate (NaH₂PO₄) |
≤ 0.8 % |
| Residual solvents (ICH Q3C) |
excluded by production process |
| Substances reducing potassium permanganate (as O) |
passes test |
| Loss on drying (130 °C) |
57.0 - 61.0 % |
| Water (according to Karl Fischer) |
57.0 - 61.0 % |
| 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 (*). |
|
| Corresponds to Ph Eur, BP, USP, JP |
|
