| Assay (complexometric, calc. on anhydrous substance) |
98.0 - 102.0 % |
| Identity (IR-spectrum) |
conforms |
| Identity (Calcium) |
conforms |
| Identity (Sodium) |
conforms |
| Appearance |
white to almost white, hygroscopic powder |
| Appearance of solution (50 g/l; water) |
clear and colorless |
| pH (200 g/l, CO₂-free water) |
6.5 - 8.0 |
| Chloride (Cl) |
≤ 0.10 % |
| Heavy metals (as Pb) |
≤ 20 ppm |
| Fe (Iron) |
≤ 80 ppm |
| Residual solvents (Ph.Eur./USP/ICH) |
excluded by manufacturing process |
| Nitrilotriacetic acid (HPLC) |
≤ 0.1 % |
| Disodium-EDTA |
≤ 1.0 % |
| Water (according to Karl Fischer) |
5.0 - 13.0 % |
| Bacterial endotoxins |
≤ 5.0 I.U./g |
| Residues of metal catalysts or metal reagents acc.to EMEA/CHMP/SWP/4446/2000 are not likely to be present. |
|
| Corresponds to Ph. Eur., BP, USP |
|
