Specification Test Results

• Identity (wet chemistry):
  passes test
• Identity (IR):
  passes test
• Appearance of solution (50 %; water):
  passes test
• Color of solution:
  passes test
• Color number:
  ≤ 45
• Spec. rotation (α 20/D; 26 %; water):
  66.3 - 67.0 °
• Spec. rotation (α 20/D; 10 %; water):
  66.3 - 67.0 °
• Electrical conductivity:
  ≤ 35 µS/cm
• Sulfite (as SO₂):
  ≤ 10 ppm
• Sulfate (SO₄):
  ≤ 0.05 %
• Heavy metals (as Pb):
  ≤ 0.0005 %
• Ca (Calcium):
  ≤ 0.05 %
• Dextrins:
  passes test
• Reducing sugars:
  passes test
• Reducing sugars (ChP):
  ≤ 0.10 %
• Residual solvents (ICH Q3C):
  excluded by production process
• Loss on Drying (105 °C):
  ≤ 0.1 %
• Sulfated ash:
  ≤ 0.1 %
• Endotoxins:
  < 2
• Microbiological purity (Total aerobic microbial count (TAMC)):
  ≤ 500 CFU/g
• Microbiological purity (Total yeast and mould count (TYMC)):
  ≤ 100 CFU/g
• Bile tolerant Gram negative Bacteria (absent in 1 g):
  passes test
• Escherichia coli (absent in 1 g):
  passes test
• Pseudomonas aeruginosa (absent in 1 g):
  passes test
• Staphylococcus aureus (absent in 1 g):
  passes test
• Candida albicans (absent in 1 g):
  passes test
• Salmonella ssp (absent in 10 g):
  passes test