Specification Test Results

• Assay (α 20/D, 100 g/l, water, calc. on anhydrous substance):
  98.5 - 101.2 %
• Assay (α 25/D, 100 g/l,water, calc. on anhydrous substance):
  98.0 - 102.0 %
• Identity:
  passes test
• Appearance of solution (EP):
  passes test
• Appearance of solution (USP):
  passes test
• Acidity or alkalinity:
  passes test
• Spec. rotation (α 20/D; 10 %; water; calc. on anhydrous substance):
  -93.5 - -91.0 °
• Spec. rotation (α 25/D; 10 %; water; calc. on anhydrous substance):
  -90.8 - -87.2 °
• Chloride (Cl):
  ≤ 0.01 %
• Sulfate (SO₄):
  ≤ 0.02 %
• Heavy metals (as Pb):
  ≤ 0.0005 %
• As (Arsenic):
  ≤ 0.0001 %
• Ba (Barium):
  passes test
• Calcium and Magnesium (as Ca):
  ≤ 0.005 %
• Cu (Copper):
  ≤ 0.0025 %
• Pb (Lead):
  ≤ 0.00001 %
• Zn (Zinc):
  ≤ 0.0025 %
• Glucose (HPLC):
  ≤ 0.5 %
• Foreign sugars:
  passes test
• 5-Hydroxymethylfurfural and related substances:
  passes test
• Residual solvents (ICH Q3C):
  excluded by the production process
• Sulfated ash:
  ≤ 0.1 %
• Water:
  ≤ 0.5 %