Specification Test Results

• Stearic acid (GC):
  40.0 - 60.0 %
• Assay (Stearic acid and palmitinic acid) (GC):
  ≥ 90.0 %
• Identity:
  passes test
• Appearance of melt (Ph Eur, BP):
  passes test
• Colour of solution (NF):
  passes test
• Acidity (Ph Eur, NF, BP):
  passes test
• Mineral acids (JP):
  passes test
• Solidification point:
  54 - 59 °C
• Heavy metals (as Pb):
  ≤ 0.0010 %
• Ni (Nickel):
  ≤ 1 ppm
• Residual solvents (Ph.Eur./USP/ICH):
  excluded by production process
• Iodine number:
  ≤ 4.0
• Acid value:
  194 - 210
• Neutral fats and mineral fats:
  passes test
• Sulfated ash:
  ≤ 0.10 %
• Particle Size (d10):
  ≥ 5 µm
• Particle Size (d50):
  about 35
• Particle Size (d90):
  ≤ 200 µm
• Specific surface area (BET):
  0.90 - 1.40 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):
  conforms
• Escherichia coli (absent in 1 g):
  conforms
• Pseudomonas aeruginosa (absent in 1 g):
  conforms
• Staphylococcus aureus (absent in 1 g):
  conforms
• Candida albicans (absent in 1 g):
  conforms
• Salmonella ssp (absent in 10 g):
  conforms