| Assay (calc. on anhydrous substance) | 97.5 - 102.0 % |
| Identity (specific rotation) | passes test |
| Identity (HPLC) | passes test |
| Identity (water) | passes test |
| Appearance of solution | passes test |
| Conductivity | ≤ 20 µS/cm |
| Related substances (sum of impurities A and B) | ≤ 0.4 % |
| Related substances (impurity C) | ≤ 0.2 % |
| Related substances (impurity D) | ≤ 0.15 % |
| Related substances (unspecified impurities) | ≤ 0.10 % |
| Related substances (Sum of all impurities) | ≤ 0.5 % |
| Dextrin | passes test |
| Soluble starch, sulfite | ≤ 15 ppm |
| Residual solvents (ICH Q3C) | excluded by the manufacturing process |
| Water (according to Karl Fischer) | ≤ 1.0 % |
| Corresponds to Reag. Ph.Eur. |
