Specification Test Results

• Assay (argentometric; calculated on dried substance):
  99.5 - 100.5 %
• Identity:
  passes test
• Appearance of solution:
  passes test
• Acidity or alkalinity:
  passes test
• Bromide (Br):
  ≤ 0.005 %
• Ferrocyanides:
  passes test
• Iodide (I):
  passes test
• Nitrite (NO₂) (UV-absorption 354nm; 1cm; 10%; water):
  ≤ 0.01
• Phosphate (PO₄):
  ≤ 0.0025 %
• Sulfate (SO₄):
  ≤ 0.0200 %
• Heavy metals (as Pb):
  ≤ 0.0003 %
• Al (Aluminium):
  ≤ 0.00002 %
• As (Arsenic):
  ≤ 0.0001 %
• Ba (Barium):
  passes test
• Ca (Calcium):
  ≤ 0.002 %
• Fe (Iron):
  ≤ 0.0002 %
• K (Potassium):
  ≤ 0.01 %
• Magnesium and alkaline-earth metals (as Ca):
  ≤ 0.0100 %
• Residual solvents (ICH Q3C):
  excluded by production process
• Loss on drying (105 °C, 2 h):
  ≤ 0.5 %
• Endotoxins (kinetic turbidimetric test):
  ≤ 2.5 I.U./g
• Microbiological purity (Total aerobic microbial count (TAMC)):
  ≤ 100.0 CFU/g
• Microbiological purity (Total yeast and mould count (TYMC)):
  ≤ 100.0 CFU/g
• DNases (Exo- and endonucleases) (not detectable):
  passes test
• RNases (not detectable):
  passes test
• Proteases (not detectable):
  passes test
• Nicking Activity (not detectable):
  passes test