Specification Test Results

• Purity (GC):
  99,8%
• Assay (m/m):
  99,2%
• Assay (V/V):
  99,5%
• Indentity (IR):
  Conforms
• Appearance:
  Conforms
• Colour:
  ≤10 Hazan
• Clarity of solution:
  Conforms
• Colour of solution:
  Conforms
• Acidity or alkalinity:
  ≤30 ppm
• Acidity (as CH₃COOH):
  ≤30 ppm
• Refractive Index (n 25/D):
  1,3589 - 1,3599
• Density (d 20 °C/20 °C):
  0,790 - 0,793
• Density (d 15,56 °C/15,56 °C):
  ≤0,7962
• Absorbance (at 240 nm):
  ≤0,40
• Absorbance (between 250 and 260 nm):
  ≤0,30
• Absorbance (between 270 and 340 nm):
  ≤0,10
• Volatile impurities (GC; acetal and acetaldehyde):
  ≤10 ppm
• Volatile impurities (GC; benzene):
  ≤2 ppm
• Volatile impurities (GC; methanol):
  ≤100 ppm
• Volatile impurities (GC; total-other impurities):
  ≤300 ppm
• Volatile impurities (GC; disregard limit):
  ≤9 ppm
• Cyclohexane (GC):
  ≤50 ppm
• 2-Propanol (GC):
  ≤30 ppm
• Evaporation residue:
  ≤0,0001%
• Water:
  ≤0,500%
• Bacterial endotoxins:
  ≤2,5 IU/ml
• Total areobic microbial unit (TAMC):
  ≤100 CFU/g
• Total combained yeasts/moulds count (TYMC):
  ≤10 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