| Assay (alkalimetric, calculated on dried substance) |
98.0 - 100.5 % |
| Identity |
passes test |
| Appearance of solution |
passes test |
| Insoluble substances |
≤ 0.2 % |
| pH-value (5 %; water) |
4.2 - 4.5 |
| Chloride (Cl) |
≤ 0.014 % |
| Sulfate (SO₄) |
≤ 0.03 % |
| Heavy metals (as Pb) |
≤ 0.001 % |
| Al (Aluminium) |
≤ 0.0002 % |
| As (Arsenic) |
≤ 0.0002 % |
| Fe (Iron) |
≤ 0.001 % |
| Aluminium, Calcium and related elements |
passes test |
| Reducing substances |
passes test |
| Residual solvents (ICH Q3C) |
excluded by manufacturing process |
| Loss on drying (130 °C) |
11.5 - 14.5 % |
| Water |
10.0 - 15.0 % |
| Endotoxins |
≤ 2.5 I.U./g |
| 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 BP,USP |
|
