Specification Test Results

• Assay (alkalimetric, calculated on anhydrous substance):
  99.5 - 100.5 %
• Identity (IR-spectrum):
  passes test
• Appearance:
  white to almost white, fine powder
• Appearance of solution (200 g/l; water):
  clear (≤ 3 NTU) and not more intense in color than reference solution Y₇, BY₇ or GY₇
• Sulfate (SO₄):
  ≤ 50 ppm
• Heavy metals (as Pb):
  ≤ 5 ppm
• Al (Aluminium):
  ≤ 0.2 ppm
• As (Arsenic):
  ≤ 1 ppm
• Hg (Mercury):
  ≤ 1 ppm
• Pb (Lead):
  ≤ 0.5 ppm
• Oxalates (as C₂H₂O₄):
  ≤ 100 ppm
• Residual solvents (ICH (Q3C)):
  excluded by manufacturing process
• Readily carbonisable substance:
  passes test
• Sulfated ash (600 °C):
  ≤ 0.05 %
• Water (according to Karl Fischer):
  7.5 - 8.8 %
• Particle size (> 0.3 mm):
  ≤ 5.0 %
• Bacterial endotoxins:
  < 0.5