Specification Test Results

• Assay (acidimetric; calculated on dried substance):
  99.5 - 100.5 %
• Assay (HPLC, calc.on dried substance):
  98.0 - 102.0 %
• Identity:
  passes test
• Appearance of solution (10 %; ethanol 96 %):
  passes test
• Chloride (Cl):
  ≤ 0.0100 %
• Sulfate (SO₄):
  ≤ 0.0200 %
• Related substances / HPLC (EP) (4-Hydroxybenzoic acid):
  ≤ 0.1 %
• Related substances / HPLC (EP) (4-Hydroxyisophthalic acid):
  ≤ 0.05 %
• Related substances / HPLC (EP) (Phenol):
  ≤ 0.02 %
• Related substances / HPLC (EP) (Largest unspecified impurity):
  ≤ 0.05 %
• Related substances / HPLC (EP) (Sum of all impurities):
  ≤ 0.2 %
• Related substances / HPLC (USP) (4-Hydroxybenzoic acid):
  ≤ 0.1 %
• Related substances / HPLC (USP) (4-Hydroxyisophthalic acid):
  ≤ 0.05 %
• Related substances / HPLC (USP) (Phenol):
  ≤ 0.02 %
• Related substances / HPLC (USP) (Largest unspecified impurity):
  ≤ 0.05 %
• Related substances / HPLC (USP) (Sum of all impurities):
  ≤ 0.2 %
• Residual solvents (ICH Q3C):
  excluded by manufacturing process
• Sulfated ash:
  ≤ 0.05 %
• Loss on drying:
  ≤ 0.5 %