| Assay (perchloric acid titration, calculated on dried substance) |
99.0 - 100.5 % |
| Identity |
passes test |
| Appearance of solution |
passes test |
| pH-value (5 %; water) |
7.5 - 8.5 |
| Chloride (Cl) |
≤ 0.01 % |
| Sulfate (SO₄) |
≤ 0.005 % |
| Heavy metals (as Pb) |
≤ 0.0004 % |
| Al (Aluminium) |
≤ 0.0001 % |
| As (Arsenic) |
≤ 0.0002 % |
| Fe (Iron) |
≤ 0.001 % |
| Hg (Mercury) |
≤ 0.0001 % |
| Na (Sodium) |
≤ 0.5 % |
| Pb (Lead) |
≤ 0.0002 % |
| free acetic acid |
≤ 0.4 % |
| Other residual solvents (ICH Q3C) |
excluded by manufacturing process |
| Substances reducing potassium permanganate (as HCOOH) |
passes test |
| Loss on Drying (105°C) |
≤ 3.0 % |
| formic acid, formate and other oxidizable impurities |
≤ 0.1 % |
| 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, JPE, E261Conforms to the purity criteria on food additives according to the current European Commission Regulation. |
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