| Assay (alkalimetric) |
99.8 - 100.5 % |
| Identity |
passes test |
| Appearance of the substance |
passes test |
| Solidification temperature |
≥ 15.6 °C |
| Foreign organic substances |
passes test |
| Formic acid, Formates and other oxidable impurities (as HCOOH) |
≤ 0.10 % |
| Heavy metals (as Pb) |
≤ 0.0005 % |
| Chloride (Cl) |
≤ 0.0002 % |
| Sulphate (SO₄) |
≤ 0.0005 % |
| Al (Aluminium) |
≤ 0.00005 % |
| As (Arsenic) |
≤ 0.00010 % |
| Cu (Copper) |
≤ 0.0005 % |
| Fe (Iron) |
≤ 0.0005 % |
| Hg (Mercury) |
≤ 0.00010 % |
| Pb (Lead) |
≤ 0.00005 % |
| Zn (Zinc) |
≤ 0.0005 % |
| Other residual solvents (ICH Q3C) |
...excluded by production process |
| Reducing substances (Ph Eur) |
passes test |
| Substances reducing potassium permanganate |
passes test |
| Evaporation residue |
≤ 0.005 % |
| 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, E260 Conforms to the purity criteria on food additives according to the current European Commission Regulation. |
|
