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
• Titrable acid:
  ≤ 0.002 meq/g
• Conductivity:
  ≤ 20 µS/cm
• Spec. rotation (α25/D):
  52.5 - 53.0 °
• In water insoluble matter:
  ≤ 0.005 %
• Chloride (Cl):
  ≤ 0.01 %
• Sulfate (SO₄):
  ≤ 0.005 %
• Heavy metals (as Pb):
  ≤ 5 ppm
• Fe (Iron):
  ≤ 5 ppm
• 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
• Starch:
  passes test
• Residual solvents (ICH Q3C):
  excluded by the manufacturing process
• Loss on drying (105 °C):
  ≤ 0.2 %
• Water (according to Karl Fischer):
  ≤ 1.0 %
• Sulfated ash (600 °C):
  ≤ 0.02 %
• Microbiological purity (Total aerobic microbial count (TAMC)):
  ≤ 100 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
• Endotoxins:
  ≤ 10 I.U./g