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