Specification Test Results

• Assay (HPLC, calc.on anhydrous substance):
  97.0 - 100.5 %
• Identity:
  passes test
• pH-value (10 %; water):
  3.5 - 7.0
• Appearance of solution (25 %; water):
  passes test
• Spec. rotation (α20/D, 10 %, borate complex, calc. on anhydrous substance):
  +4.0 - +7.0 °
• Conductivity (25°C) (20 %; water):
  ≤ 20
• Chloride (Cl):
  ≤ 0.002 %
• Sulfate (SO₄):
  ≤ 0.006 %
• Heavy metals (as Pb):
  ≤ 5 ppm
• As (Arsenic):
  ≤ 1.3 ppm
• Ni (Nickel) (#):
  ≤ 1 ppm
• Pb (Lead):
  ≤ 0.5 ppm
• Related substances (HPLC, EP) (Major impurity (Mannitol)):
  ≤ 2.0 %
• Related substances (HPLC, EP) (Sum of all impurities):
  ≤ 3.0 %
• Reducing sugars after hydrolysis/total sugar (as glucose):
  ≤ 0.8
• Reducing sugars (as glucose):
  ≤ 0.11 %
• Sulfated ash:
  ≤ 0.02 %
• Loss on drying:
  ≤ 2.0 %
• Water:
  ≤ 1.5 %
• Residual solvents (ICH Q3C):
  excluded by manufacturing process
• Microbiological test:
  passes test
• Colony count (aerobic bacteria (TAMC)):
  ≤ 10²
• Colony count (Yeasts and moulds (TYMC)):
  ≤ 10²
• Salmonella spp.:
  in 10g Substance not detectable
• E.coli:
  in 1g substance not detectable
• Pseudomonas aeruginosa:
  in 1g substance not detectable
• Staphylococcus aureus:
  in 1g substance not detectable
• Candida albicans:
  In 1g substance not detectable
• Endotoxins:
  ≤ 1