Specification Test Results

• Assay (acidimetric, NH₃):
  25.0 - 30.0 %
• Identity:
  passes test
• Appearance of solution:
  passes test
• Density (20/20°C):
  0.892 - 0.910
• Carbonate (as CO₂):
  ≤ 0.0060 %
• Chloride (Cl):
  ≤ 0.00010 %
• Sulfate (SO₄):
  ≤ 0.0005 %
• Pyridine and related substances:
  ≤ 0.0002 %
• Cu (Copper):
  ≤ 0.00005 %
• Fe (Iron):
  ≤ 0.000025 %
• Oxidizable substances:
  passes test
• Substances reducing potassium permanganate (as O):
  ≤ 0.00075 %
• Residual solvents (ICH Q3C):
  ...excluded by production process
• Evaporation residue:
  ≤ 0.0018 %
• Residue on ignition (as SO₄):
  ≤ 0.002 %
• Elemental impurity specifications have been set considering ICH Q3D (Guideline for Elemental Impurities). Class 1-3 elements are not likely to be present above the ICH Q3D option 1 limit, unless specified and indicated (*).:
  ≤ 0.002 %