Specification Test Results

• Assay (Perchloric acid titration, calc. on anhydrous substance (Ph Eur)):
  99.0 - 101.0 %
• Assay (Perchloric acid titration, previously dried substance) (JP/USP):
  99.0 - 100.5 %
• Identity (Na):
  passes test
• Identity (Citrate):
  passes test
• Identity (reaction upon ignition):
  passes test
• Appearance:
  white to almost white crystals
• Appearance of solution (100 g/l, CO₂-free water):
  clear and colorless
• Acidity or alkalinity:
  passes test
• pH (50 g/l CO₂-free water):
  7.5 - 8.5
• Chloride (Cl):
  ≤ 50 ppm
• Sulfate (SO₄):
  ≤ 150 ppm
• Heavy metals (as Pb):
  ≤ 5 ppm
• Al (Aluminium):
  ≤ 5 ppm
• As (Arsenic):
  ≤ 1 ppm
• Hg (Mercury):
  ≤ 1 ppm
• Pb (Lead):
  ≤ 1 ppm
• Oxalate (as C₂H₂O₄):
  ≤ 100 ppm
• Tartrate (C₄H₄O₆):
  passes test
• Residual solvents (ICH (Q3C)):
  excluded by manufacturing process
• Readily carbonisable substance:
  passes test
• Water (according to Karl Fischer):
  11.0 - 13.0 %
• Loss on drying (180 °C, 18 h):
  10.0 - 13.0 %