Specification Test Results

• Appearance:
  White to almost white Crystalline powder
• Infrared spectrum:
  Conforms
• Water:
  ≤1.0 % (K.F.)
• Loss on drying:
  ≤0.5 % (1 g, 80°C, 2 hrs)
• Sulfated ash:
  ≤0.1 %
• GC:
  ≥78 % (beta-lactose)
• Appearance of solution:
  (per Ph. Eur.) Passes test
• Microbial contamination:
  (per Ph. Eur.) Passes test
• Acidity/alkalinity:
  ≤0.4 ml/6g (ml 0.1N NaOH/6g)
• Specific optical rotation:
  +54.4° to +55.9° (20°C, 589 nm) (c=10, H2O/NH3) (on anhydrous basis)
• Absorbance:
  (per Ph. Eur.) Passes test
• Heavy metals (as Pb):
  ≤5 ppm