Specification Test Results

• Assay (alkalimetric, calculated on dried substance):
  98.0 - 101.0 %
• Assay (out of dried substance):
  ≥ 98.0 %
• Identity:
  passes test
• Appearance of solution:
  passes test
• In water insoluble matter:
  ≤ 0.2 %
• pH-value (1 %, water):
  8.7 - 9.4
• Chloride (Cl):
  ≤ 0.02 %
• Fluoride (F):
  ≤ 0.0010 %
• Sulfate (SO₄):
  ≤ 0.1 %
• Heavy metals (as Pb):
  ≤ 0.0010 %
• Al (Aluminium):
  ≤ 0.0005 %
• As (Arsenic):
  ≤ 0.0001 %
• Cd (Cadmium):
  ≤ 0.0001 %
• Fe (Iron):
  ≤ 0.0010 %
• Hg (Mercury):
  ≤ 0.0001 %
• Na (Sodium):
  ≤ 1.5 %
• Pb (Lead):
  ≤ 0.0001 %
• Potassium dihydrogen phosphate:
  ≤ 2.5 %
• Residual solvents (ICH Q3C):
  excluded by manufacturing process
• Reducing substances:
  passes test
• Loss on drying (130 °C):
  ≤ 2.0 %