| Assay (acidimetric; calculated on dried substance) |
99.6 - 101.0 % |
| Identity |
conforms |
| Appearance of solution (5 %; methanol) |
conforms |
| Melting point |
151.5 - 154.0 °C |
| Chloride (Cl) |
≤ 0.0200 % |
| Nitrate (NO₃) |
≤ 0.0030 % |
| Sulphate (SO₄) |
≤ 0.0500 % |
| Heavy metals (as Pb) |
≤ 0.0010 % |
| Al (Aluminium)* |
≤ 1 ppm |
| As (Arsenic) |
≤ 0.0003 % |
| Cu (Copper)* |
≤ 25 ppm |
| Fe (Iron) |
≤ 0.0010 % |
| Hg (Mercury) |
≤ 0.0001 % |
| Pb (Lead) |
≤ 0.0002 % |
| Pd (Palladium)* |
≤ 1 ppm |
| Pt (Platinum)* |
≤ 1 ppm |
| V (Vanadium)* |
≤ 1 ppm |
| Related substances (HPLC) (largest single impurity) |
≤ 0.1 % |
| Related substances (HPLC) (Sum of all impurities) |
≤ 0.5 % |
| Residual solvents (ICH Q3C) |
excluded by production process |
| Sulfated ash (600 °C) |
≤ 0.002 % |
| Loss on Drying (105°C) |
≤ 0.2 % |
| Water |
≤ 0.2 % |
| 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 the purity criteria on food additives according to the current European Commission Regulation. |
|
| Corresponds to Ph Eur., NF, FCC, E 355 |
|
