Specification Test Results

• Assay (alkalimetric, calculated on dried substance):
  98.5 - 101.0 %
• Assay (Perchloric acid titration, calc. on anhydrous substance):
  99.0 - 101.0 %
• Identity (IR-spectrum):
  passes test
• Identity (Chloride):
  passes test
• Appearance:
  white to almost white crystalline powder or colorless crystals
• Appearance of solution (50 g/l CO₂-free water):
  clear and not more intense in color than reference solution BY₆
• Appearance of solution (100 g/l, CO₂-free water):
  clear and colorless
• pH (50 g/l CO₂-free water):
  3.0 - 5.0
• pH (100 g/l, CO₂-free water):
  3.5 - 4.5
• Spec. rotation (α 20/D, 110 g/l, hydrochloric acid 120 g/l, calc. on dried substance):
  +9.2 to +10.6
• Spec. rotation (α 20/D, 110 g/l, hydrochloric acid 6 mol/l, calc. on anhydrous substance):
  +9.2 to +10.6
• Sulfate (SO₄):
  ≤ 200 ppm
• Heavy metals (as Pb):
  ≤ 10 ppm
• Fe (Iron):
  ≤ 10 ppm
• Related substances (TLC):
  passes test
• 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 (150 °C):
  7.0 - 10.0 %
• Water (according to Karl Fischer):
  7.2 - 10.0 %
• Bacterial endotoxins:
  ≤ 20 I.U./g
• Microbiological test (total aerobic microbial count (TAMC)):
  ≤ 10²
• Microbiological test (total yeast and mould count (TYMC)):
  ≤ 10¹