| Assay (acidimetric, calc. on anhydrous substance) |
99.0 - 100.5 % |
| Assay (HPLC, calc. on anhydrous substance) |
99.0 - 101.0 % |
| Identity |
passes test |
| Appearance of solution (100 g/l, water) |
passes test |
| Acidity or alkalinity |
passes test |
| Chloride (Cl) |
≤ 0.02 % |
| Sulphate (SO₄) |
≤ 0.01 % |
| Total chlorine |
≤ 0.03 % |
| Heavy metals (as Pb) |
≤ 10 ppm |
| As (Arsenic) |
≤ 1 ppm |
| Cd (Cadmium) |
≤ 10 ppm |
| Cu (Copper) |
≤ 10 ppm |
| Hg (Mercury) |
≤ 1 ppm |
| Pb (Lead) |
≤ 2 ppm |
| Zn (Zinc) |
≤ 10 ppm |
| Benzene |
≤ 2 ppm |
| Toluene |
≤ 890 ppm |
| Other residual solvents (ICH Q3C) |
excluded by production process |
| Multinuclear acids |
passes test |
| Oxidizable matter |
passes test |
| Water (according to Karl Fischer) |
≤ 1.5 % |
| 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 Ph Eur,BP,NF,FCC,E 211 |
|