Specification Test Results

• Assay (Calculated on Dried Substance According to Ph. Eur.):
  98.0 - 101.0%
• Assay (Calculated on Dried Substance According to USP):
  98.0 - 100.5%
• Identity:
  Passes Test
• Appearance of Solution:
  Passes Test
• In Water Insoluble Matter:
  ≤0.3%
• pH-Value (5%; Water):
  8.9 - 9.2
• Chloride (Cl):
  ≤0.005%
• Sulfate (SO₄):
  ≤0.02%
• Heavy Metals (as Pb):
  ≤0.001%
• As (Arsenic):
  ≤0.0002%
• Fe (Iron):
  ≤0.001%
• Sodium Dihydrogen Phosphate (NaH₂PO₄):
  ≤1.7%
• Residual Solvents (ICH Q3C):
  Excluded by Manufacturing Process
• Substances Reducing Potassium Permanganate (as O):
  Passes Test
• Loss on drying (130 °C):
  19.5 - 21.0 %