Specification Test Results

• Assay (iodometric, calc. on dried substance):
  98.0 - 100.5 %
• Identity (IR-spectrum):
  conforms
• Identity (Tillmans-Reaction):
  conforms
• Appearance:
  white or yellowish-white powder
• Appearance of solution (100 g/l, methanol):
  clear and not more intense in colour than colour reference solution BY4 (Ph. Eur.)
• Melting range (lower value):
  ≥ 107 °C
• Melting range (upper value):
  ≤ 117 °C
• Spec. rotation α 20/D (100 g/l, Metanol, calc on dried basis):
  +21 - +24 °
• Spec. rotation α 20/D (50 g/l, methanol):
  +21 - +24 °
• Spec. rotation α 25/D (100 g/l, Metanol, calc on dried basis):
  +21 - +24 °
• Spec. rotation α 25/D (100 g/l, methanol):
  +21 - +24 °
• Heavy metals (as Pb):
  ≤ 10 ppm
• As (Arsenic):
  ≤ 3 ppm
• Cu (Copper):
  ≤ 25 ppm
• Hg (Mercury):
  ≤ 1 ppm
• Pb (Lead):
  ≤ 2 ppm
• Zn (Zinc):
  ≤ 25 ppm
• Ethyl acetate (HS-GC):
  ≤ 5000 ppm
• Methylisobutylketone (HS-GC):
  ≤ 5000 ppm
• Other residual solvents (ICH Q3C):
  excluded by manufacuring process
• Sulfated ash (600 °C):
  ≤ 0.1 %
• Loss on drying (5 h, 60 °C, Vacuum):
  ≤ 1.0 %
• Residues of metal catalysts or metal reagents acc.to EMEA/CHMP/SWP/4446/2000:
  are not likely to be present.
• Correspond to Ph Eur, BP, NF, FCC, E 304:
  Conforms to the purity criteria on food additives according to the current ECR