Specification Test Results

• Assay (alkalimetric, calculated on dried substance):
  98.0 - 100.5 %
• Assay (alkalimetric; dried substance):
  98.0 - 101.0 %
• Identity:
  passes test
• Appearance of solution:
  passes test
• In water insoluble matter (calculated on dried substance):
  ≤ 0.15 %
• pH-value (1 %, water):
  4.1 - 4.7
• pH-value (5 %; water):
  4.2 - 4.5
• pH-value (5.7 %; water):
  4.1 - 4.5
• Chloride (Cl):
  ≤ 0.005 %
• Hydrogenphosphate (HPO₄):
  ≤ 0.5 %
• Sulfate (SO₄):
  ≤ 0.01 %
• Heavy metals (as Pb):
  ≤ 0.0005 %
• Al, Ca and other elements detectable with ammonia:
  passes test
• As (Arsenic):
  ≤ 0.0002 %
• Fe (Iron):
  ≤ 0.0010 %
• Residual solvents (ICH Q3C):
  excluded by production process
• Substances reducing potassium permanganate (as O):
  passes test
• Loss on drying (130 °C):
  22.0 - 24.0 %
• Endotoxins:
  ≤ 2.5 I.U./g
• Total aerobic microbial count:
  ≤ 1E+02 CFU/g
• Total yeast and mould count:
  ≤ 1E+02 CFU/g
• E.coli (absent in 1g):
  passes test
• Pseudomonas aeruginosa (absent in 1g):
  passes test
• Staphylococcus aureus (absent in 1g):
  passes test
• Salmonella species (absent in 10g):
  passes test
• Bile tolerante gram negative bacteria (absent in 1g):
  passes test
• Candida albicans (absent in 1g):
  passes test
• DNases (Exo- and endonucleases) (not detectable):
  passes test
• RNases (not detectable):
  passes test
• Proteases (not detectable):
  passes test