Specification Test Results

• Appearance:
  White to almost white Crystalline powder
• Assay:
  97.5 to 102.0 % (Anhydrous substance)
• Water:
  ≤1.0 % (K.F.)
• Loss on drying:
  ≤0.5 % (1 g, 105°C, 16 h)
• Sulfated ash:
  ≤0.1 % (1 g, 600°C)
• Appearance of solution:
  (EP) Passes test
• Identification:
  Passes test (EP, USP)
• Related substances:
  ≤0.4 % (sum of impurities A and B)
• Specific optical rotation:
  +52.5° to +53.3° (20°C, 589 nm) (C=10,H2O/dilute NH3) (Anhydrous substance)
• Acidity:
  (USP) Passes test
• Color of solution:
  (USP) Passes test
• Chloride (Cl):
  ≤0.018 %
• Sulfate (SO4):
  ≤0.025 %
• Arsenic (As):
  ≤1 µg/g
• Soluble starch, sulfite:
  ≤15 ppm (EP)
• Dextrin:
  (EP, USP) Passes test
• Conductivity:
  ≤20 µS/cm