Specification Test Results

• Assay (alkalimetric, calculated on dried substance):
  98.0 - 100.5 %
• Assay (alkalimetric; dried substance):
  ≥ 99.0 %
• Identity:
  passes test
• Appearance of solution:
  passes test
• Insoluble substances:
  ≤ 0.2 %
• pH-value (2 %; water):
  4.2 - 4.6
• pH-value (5 %; water):
  4.2 - 4.5
• Carbonate:
  passes test
• Condensed phosphate:
  passes test
• Chloride (Cl):
  ≤ 0.009 %
• Fluoride (F):
  ≤ 0.0010 %
• Sulfate (SO₄):
  ≤ 0.017 %
• Heavy metals (as Pb):
  ≤ 0.0010 %
• Al (Aluminium):
  ≤ 0.0005 %
• As (Arsenic):
  ≤ 0.0002 %
• Fe (Iron):
  ≤ 0.0010 %
• Na (Sodium):
  ≤ 0.1 %
• 0:
  passes test
• Pb (Lead):
  ≤ 0.0004 %
• Endotoxins:
  ≤ 2.5 I.U./g
• Total aerobic microbial count:
  ≤ 100 CFU/g
• Total yeast and mould count:
  ≤ 100 CFU/g
• DNases (Exo- and endonucleases) (not detectable):
  passes test
• RNases (not detectable):
  passes test
• Proteases (not detectable):
  passes test
• Residual solvents (ICH Q3C):
  excluded by manufacturing process
• Reducing substances:
  passes test
• Loss on drying (105 °C):
  ≤ 0.5 %
• Loss on drying (130 °C):
  ≤ 1.0 %