Specification Test Results

• all-rac-α-Tocopheryl acetate content (GC, Ph. Eur.):
  50.0 - 57.5 %
• all-rac-α-Tocopheryl acetate content (GC, USP):
  49.0 - 57.5 %
• Identity (TLC):
  conforms
• Identity (GC):
  conforms
• Optical rotation α 20/D (all-rac-α-Tocopheryl acetate):
  -0.01 - 0.01 °
• Acetic acid (HS-GC):
  ≤ 5000 ppm
• Heptane (HS-GC):
  ≤ 5000 ppm
• Methanol (HS-GC):
  ≤ 3000 ppm
• Pyridine (HS-GC):
  ≤ 200 ppm
• Toluene (HS-GC):
  ≤ 890 ppm
• Other residual solvents (Ph.Eur./USP/ICH):
  excluded by production process
• Loss on drying (130 °C, vacuum, 4 h):
  ≤ 5.0 %
• Total aerobic microbial count (TAMC):
  ≤ 100 CFU/g
• Total combined yeasts/moulds count (TYMC):
  ≤ 100 CFU/g
• Bile-tolerant gram-negative bacteria (absent in 1 g):
  passes test
• Candida albicans (absent in 1 g):
  passes test
• Escherichia coli (absent in 1 g):
  passes test
• Pseudomonas aeruginosa (absent in 1 g):
  passes test
• Salmonella (absent in 10 g):
  passes test
• Staphylococcus aureus (absent in 1 g):
  passes test