| Assay (complexometric) |
99.0 - 101.0 % |
| Assay Acetic acid (potentiometric) |
≤ 0.5 % |
| Identity |
passes test |
| Appearance of solution |
passes test |
| Insoluble matter |
≤ 0.005 % |
| pH-value (5 %; water) |
6.0 - 7.0 |
| Chloride (Cl) |
≤ 0.0050 % |
| Sulfate (SO₄) |
≤ 0.0100 % |
| Al (Aluminium) |
≤ 0.0005 % |
| As (Arsenic) |
≤ 0.0002 % |
| Cd (Cadmium) (*) |
≤ 0.0002 % |
| Cu (Copper) |
≤ 0.0050 % |
| Fe (Iron) |
≤ 0.0050 % |
| Pb (Lead) |
≤ 0.0010 % |
| Alkali- and alkaline earth metals |
≤ 0.2 % |
| Other residual solvents (ICH Q3C) |
excluded by manufacturing process |
| Reducing substances |
passes test |
| 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,USP |
|
