Specification Test Results

• Assay (perchloric acid titration, calculated on dried substance):
  98.5 - 101.0 %
• Identity (IR-spectrum):
  passes test
• Appearance:
  white to almost white, crystalline powder or colorless crystals
• Appearance of solution (50 g/l; water):
  clear and not more intense in color than reference solution BY₆
• Appearance of solution (100 g/l, CO₂-free water):
  clear and colorless
• Spec. rotation (α 20/D, 80 g/l, hydrochloric acid 250 g/l, calc. on dried substance):
  +25.5 to +28.5
• Spec. rotation (α 25/D, 80 g/l, hydrochloric acid 6 mol/l, calc. on dried substance):
  +26.3 to +27.7
• Spec. rotation (α 20/D, 80 g/l, hydrochloric acid 6 mol/l,previously dried substance):
  +26.9 to +27.9
• pH (100 g/l, CO₂-free water):
  10.5 - 12.0
• Chloride (Cl):
  ≤ 200 ppm
• Sulfate (SO₄):
  ≤ 200 ppm
• Heavy metals (as Pb):
  ≤ 10 ppm
• Cu (Copper)*:
  ≤ 25 ppm
• Fe (Iron):
  ≤ 10 ppm
• Fe (Iron) (ICP):
  ≤ 10 ppm
• Mn (Manganese):
  ≤ 25 ppm
• Mo (Molybdenum)*:
  ≤ 2.5 ppm
• Ni (Nickel)*:
  ≤ 2 ppm
• Zn (Zinc):
  ≤ 130 ppm
• Related Compounds, total (TLC):
  ≤ 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):
  ≤ 0.5 %
• Residual solvents (ICH Q3C):
  excluded by manufacturing process
• Sulfated ash (600 °C):
  ≤ 0.1 %
• Loss on drying (105 °C; 3 h):
  ≤ 0.30 %
• Bacterial endotoxins:
  ≤ 2.0 I.U./g