Assay (Perchloric acid titration, calc. on anhydrous substance (Ph Eur)) | 99.0 - 101.0 % |
Assay (Perchloric acid titration, previously dried substance) (JP/USP) | 99.0 - 100.5 % |
Özdeşlik (Na) | Testi geçer |
Özdeşlik (Citrate) | Testi geçer |
Özdeşlik (reaction upon ignition) | Testi geçer |
Appearance | white to almost white crystals |
Appearance of solution (100 g/l, CO₂-free water) | clear and colorless |
Asitlik or alkalinity | Testi geçer |
pH (50 g/l CO₂-free water) | 7.5 - 8.5 |
Chloride (Cl) | ≤ 50 ppm |
Sulfate (SO₄) | ≤ 150 ppm |
Heavy metals (as Pb) | ≤ 5 ppm |
Al (Aluminium) | ≤ 5 ppm |
As (Arsenic) | ≤ 1 ppm |
Hg (Mercury) | ≤ 1 ppm |
Pb (Lead) | ≤ 1 ppm |
Oxalate (as C₂H₂O₄) | ≤ 100 ppm |
Tartrate (C₄H₄O₆) | Testi geçer |
Residual solvents (ICH (Q3C)) | excluded by manufacturing process |
Readily carbonisable substance | Testi geçer |
Su (according to Karl Fischer) | 11.0 - 13.0 % |
Loss on drying (180 °C, 18 h) | 10.0 - 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 331 Conforms to the purity criteria on food additives according to the current European Commission Regulation. |