Specification Test Results

• Assay (bromatometric):
  99.0 - 100.5 %
• Assay (bromatometric, calc. on anhydrous substance):
  99.0 - 100.5 %
• Identity (IR-spectrum):
  passes test
• Identity (wet chemistry):
  passes test
• Appearance:
  colourless or faintly pink or faintly yellowish crystals or crystalline masses, deliquescent
• Appearance of solution (67 g/l, water):
  clear and not more intensely coloured than reference solution B6
• Acidic substances:
  passes test
• Solidification temperature:
  ≥ 39.5 °C
• Fe (Iron):
  ≤ 1 ppm
• Benzene (HS-GC):
  ≤ 2 ppm
• Methanol (HS-GC):
  ≤ 3000 ppm
• Acetone (HS-GC):
  ≤ 2 ppm
• Anisole:
  ≤ 10 ppm
• Cumene (HS-GC):
  ≤ 70 ppm
• Methylisobutylketone (HS-GC):
  ≤ 2 ppm
• Other residual solvents (ICH (Q3C)):
  excluded by manufacturing process
• Residue on evaporation (105 °C, 1 h):
  ≤ 0.05 %
• Residue on evaporation (105 °C):
  ≤ 0.05 %
• Water (according to Karl Fischer):
  ≤ 0.5 %