Specifications | |
---|---|
Assay (complexometric) | 99.0 - 100.5 % |
Assay (complexometric; calculated on dried substance) | 99.0 - 100.5 % |
Identity | passes test |
Appearance of solution | passes test |
pH-value (10 %; water) | 3.0 - 3.5 |
Heavy metals (as Pb) | ≤ 0.002 % |
Cr (Chromium) (*) | ≤ 0.0003 % |
Fe (Iron) | ≤ 0.01 % |
NH₄ (Ammonium) | ≤ 0.2 % |
Residual solvents (ICH Q3C) | excluded by manufacturing process |
Loss on drying (400 °C) | 43.0 - 46.0 % |
* specified acc. to EMEA/CHMP/SWP/4446/2000. Other residues of metal catalysts or metal reagents acc. to this guideline are not likely to be present. | |
Corresponds to Ph Eur,BP,USP |