| Assay (alkalimetric, calculated on dried substance) | 98.5 - 101.0 % |
| Identity (IR-spectrum) | passes test |
| Identity (Chloride) | passes test |
| Appearance | white or almost white, crystalline powder or colorless crystals |
| Appearance of solution (25 g/l, water) | clear and not more intense in color than reference solution BY6 |
| Spec. rotation (α 20/D, 80 g/l, hydrochloric acid 250 g/l, calc. on dried substance) | +5.5 to +7.0 |
| Spec. rotation (α 25/D, 80 g/l, hydrochloric acid 6 mol/l, calc. on dried substance) | +5.7 to +6.8 |
| Sulfate (SO₄) | ≤ 300 ppm |
| Heavy metals (as Pb) | ≤ 10 ppm |
| Fe (Iron) | ≤ 20 ppm |
| Related Compounds, total (TLC) | ≤ 0.5 % |
| Ninhydrin-positive substances (LC)
(impurity A (570 nm)) | ≤ 0.5 % |
| Ninhydrin-positive substances (LC)
(any ninhydrin-positive impurity) | ≤ 0.2 % |
| Ninhydrin-positive substances (LC) (ammonium (570 nm)) | ≤ 0.02 % |
| Ninhydrin-positive substances (LC)
(total impurities) | ≤ 1.0 % |
| Residual solvents (ICH Q3C) | excluded by manufacturing process |
| Sulfated ash (600 °C) | ≤ 0.1 % |
| Loss on drying (Vacuum < 0.7 kPa, P₂O₅, 24 h) | 8.0 - 12.0 % |
| Bacterial endotoxins | ≤ 6.0 I.U./g |
