Specification Test Results

• Assay (Mg; calculated on dried substance):
  4.0 - 5.0 %
• Identity:
  passes test
• Palmitic- stearic acid components of fatty acids:
  ≥ 95 %
• Stearic acid component of fatty acids:
  60 - 70 %
• Acidity or alkalinity:
  passes test
• Chloride (Cl):
  ≤ 0.10 %
• Sulphate (SO₄):
  ≤ 0.3 %
• Heavy metals (as Pb):
  ≤ 0.0020 %
• Cd (Cadmium):
  ≤ 0.0001 %
• Ni (Nickel):
  ≤ 0.00050 %
• Pb (Lead):
  ≤ 0.0005 %
• Residual solvents (Ph.Eur./USP/ICH):
  excluded by the production process
• Acid value:
  195 - 210
• Loss on Drying (105°C):
  ≤ 4.0 %
• Particle Size (d10):
  ≥ 1 µm
• Particle Size (d50):
  about 5
• Particle Size (d90):
  ≤ 20 µm
• Specific surface area (BET):
  5 - 12 m²/g
• Microbiological purity (Total aerobic microbial count (TAMC)):
  ≤ 1E+03 CFU/g
• Microbiological purity (Total yeast and mould count (TYMC)):
  ≤ 1E+02 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