| Assay (perchloric acid titration, calculated on dried substance) |
99.0 - 100.5 % |
| Assay (perchloric acid titration after drying) |
99.0 - 100.5 % |
| Identity |
passes test |
| Appearance of solution |
passes test |
| Alkalinity |
passes test |
| Acidity or alkalinity |
passes test |
| pH-value (5 %; water) |
7.5 - 9.0 |
| Chloride (Cl) |
≤ 0.0050 % |
| Sulfate (SO₄) |
≤ 0.0150 % |
| Heavy metals (as Pb) |
≤ 0.0005 % |
| Al (Aluminium) |
≤ 0.0001 % |
| As (Arsenic) |
≤ 0.0001 % |
| Hg (Mercury) |
≤ 0.0001 % |
| Na (Sodium) |
≤ 0.3 % |
| Pb (Lead) |
≤ 0.0001 % |
| Oxalate (C₂O₄) |
≤ 0.009 % |
| Tartrate (C₄H₄O₆) |
passes test |
| Residual solvents (ICH Q3C) |
excluded by manufacturing process |
| Readily carbonisable substance |
passes test |
| Loss on drying (180 °C) |
4.0 - 6.0 % |
| Water |
4.0 - 7.0 % |
| 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, FCC, E 332Conforms to the purity criteria on food additives according to the current European Commission Regulation. |
|
