Specification Test Results

• Assay (iodometric):
  99.0 - 100.5 %
• Assay (iodometric, dried substance):
  98.5 - 100.5 %
• Identity:
  passes test
• Appearance of solution:
  passes test
• Chloride (Cl):
  ≤ 0.0100 %
• Al (Aluminium):
  ≤ 0.0005 %
• Ca (Calcium):
  ≤ 0.005 %
• Cr (Chromium):
  ≤ 0.005 %
• Fe (Iron) (*):
  ≤ 0.003 %
• K (Potassium):
  ≤ 0.01 %
• Na (Sodium):
  ≤ 0.02 %
• Ni (Nickel) (*):
  ≤ 0.005 %
• Pb (Lead):
  ≤ 0.0050 %
• Zn (Zinc):
  ≤ 0.03 %
• Residual solvents (ICH Q3C):
  excluded by manufacturing process
• Loss on drying (250 °C):
  35.0 - 36.5 %
• Particle size (< 0,18 mm):
  100%