Specification Test Results

• Assay (acidimetric; calculated on dried substance):
  99.5 - 100.5 %
• Assay (acidimetric):
  99.0 - 101.0 %
• Identity:
  passes test
• Appearance of solution:
  passes test
• Insoluble matter:
  passes test
• pH-value (1 %, water):
  8.0 - 8.6
• pH-value (5 %; water):
  7.9 - 8.4
• Carbonate (CO₃):
  passes test
• Chloride (Cl):
  ≤ 0.015 %
• Sulphate (SO₄):
  ≤ 0.01 %
• Sulfur compounds (as SO₄):
  ≤ 0.015 %
• Heavy metals (as Pb):
  ≤ 0.0005 %
• Al (Aluminium):
  ≤ 0.00005 %
• As (Arsenic):
  ≤ 0.0002 %
• Ca (Calcium):
  ≤ 0.01 %
• Cu (Copper):
  ≤ 0.0005 %
• Fe (Iron):
  ≤ 0.002 %
• Hg (Mercury):
  ≤ 0.0001 %
• NH₄ (Ammonium):
  ≤ 0.002 %
• NH₄ (Ammonium) according to USP:
  ≤ 0.002 %
• NH₄ (Ammonium) according to JP:
  passes test
• Pb (Lead):
  ≤ 0.0002 %
• Zn (Zinc):
  ≤ 0.0025 %
• Residual solvents (ICH Q3C):
  excluded by production process
• Loss on drying (Silica gel):
  ≤ 0.25 %