Specification Test Results

• Solid matter:
  69.0 - 72.0 %
• Sorbitol (HPLC, calc.on anhydrous substance):
  92.0 - 101.0 %
• Sorbitol (HPLC):
  ≥ 65.0 %
• Identity:
  passes test
• Appearance of solution (10 %; water):
  passes test
• pH-value (14 %; water):
  5.0 - 7.0
• conductivity (25°C):
  ≤ 10
• As (Arsenic):
  ≤ 0.0001 %
• Ni (Nickel) (#):
  ≤ 0.0001 %
• Pb (Lead):
  ≤ 0.00005 %
• Ethylene glycol (HPLC):
  ≤ 0.10 %
• Diethylene glycol (HPLC):
  ≤ 0.10 %
• Reducing sugars after hydrolysis/total sugar (as glucose):
  ≤ 0.5
• Reducing sugars (as glucose):
  ≤ 0.2
• Sulfated ash:
  ≤ 0.1
• Water:
  28.5 - 31.0 %
• Residues of solvents (ICH Q3C):
  excluded by manufacturing process