| Assay (complexometric, calc. on the ignited basis) |
98.0 - 100.5 % |
| Assay (complexometric, calculated on the ignited basis according to USP) |
96.0 - 100.5 % |
| Identity |
passes test |
| Appearance of solution |
passes test |
| Substances soluble in water |
≤ 1.0 % |
| Substances insoluble in acetic acid |
≤ 0.1 % |
| Substances insoluble in acid |
≤ 0.1 % |
| Free alkali (as NaOH) |
≤ 0.6 % |
| Chloride (Cl) |
≤ 0.15 % |
| Sulfate (SO₄) |
≤ 0.5 % |
| As (Arsenic) |
≤ 0.0003 % |
| Ca (Calcium) |
≤ 1.0 % |
| Co (Cobalt)* |
≤ 0.0010 |
| Fe (Iron) |
≤ 0.05 % |
| Ni (Nickel)* |
≤ 0.1000 |
| Pb (Lead) |
≤ 0.0002 % |
| V (Vanadium)* |
≤ 0.0010 |
| Heavy metals (as Pb) |
≤ 0.0020 % |
| Residual solvents (ICH Q3C) |
passes test |
| Loss on ignition (900 °C) |
≤ 5.0 % |
| Bulk density |
≤ 0.15 g/ml |
| 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, E 530 Conforms to the purity criteria on food additives according to the current European Commission Regulation. |
|
