Specification Test Results

• Assay (calc. on anhydrous substance):
  97.5 - 102.0 %
• Identity (IR):
  passes test
• Identity (spec. rotation calc. on anhydrous substance):
  passes test
• Identity (HPLC):
  passes test
• Identity (water):
  passes test
• Appearance of solution:
  passes test
• Color and clarity of solution:
  passes test
• Conductivity:
  ≤ 20 µS/cm
• Heavy metals (as Pb):
  ≤ 5 ppm
• Cu (Copper):
  ≤ 0.0025 %
• Zn (Zinc):
  ≤ 0.0025 %
• Related substances [sum of impurities A (maltose) and B (isomaltose)!:
  ≤ 0.4 %
• Related substances [Impurity C (maltotriose)!:
  ≤ 0.2 %
• Related substances [Impurity D (fructose)!:
  ≤ 0.15 %
• Related substances (unspecified impurities):
  ≤ 0.10 %
• Related substances (Sum of all impurities):
  ≤ 0.5 %
• Dextrin:
  passes test
• Soluble starch, sulfite:
  ≤ 15 ppm
• Residual solvents (ICH Q3C):
  excluded by manucaturing process
• Water (according to Karl Fischer):
  7.5 - 9.5 %
• Endotoxins:
  ≤ 2.5 I.U./g
• Microbiological purity (Total aerobic microbial count (TAMC)):
  ≤ 1000 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