| Assay (perchloric acid titration, calculated on dried substance) |
99.0 - 100.5 % |
| Identity |
passes test |
| Appearance of solution |
passes test |
| Acidity or alkalinity |
passes test |
| Alkalinity |
passes test |
| pH-value (5 %; water) |
7.5 - 8.5 |
| Chloride (Cl) |
≤ 0.0050 % |
| Oxalate (C₂O₄) |
≤ 0.01 % |
| Sulfate (SO₄) |
≤ 0.0150 % |
| Heavy metals (as Pb) |
≤ 0.0005 % |
| As (Arsenic) |
≤ 0.0001 % |
| Ba (Barium) |
≤ 0.003 % |
| Fe (Iron) |
≤ 0.003 % |
| Hg (Mercury) |
≤ 0.0001 % |
| Pb (Lead) |
≤ 0.0001 % |
| Tartrate (as C₄H₄O₆) |
passes test |
| Residual solvents (ICH Q3C) |
excluded by manufacturing process |
| Readily carbonisable substance |
passes test |
| Loss on drying (180 °C) |
11.0 - 13.0 % |
| 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,JP,USP,E 331Conforms to the purity criteria on food additives according to the current European Commission Regulation. |
|
