مشخصات فنی محصول | |
---|---|
Assay (calc. on anhydrous substance) | 97.5 - 102.0 % |
Identity | 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 (EP) | ≤ 15 ppm |
Residual solvents (ICH Q3C) | excluded by the manufacturing process |
Water (according to Karl Fischer) | ≤ 1.0 % |
Corresponds to Reag. Ph.Eur. |