Specification Test Results

• Assay (acidimetric, calc. on anhydrous substance):
  99.0 - 103.0 %
• Identity (IR-spectrum):
  passes test
• Identity (GC):
  conforms
• Appearance:
  colorless to slightly yellow viscose liquid
• Appearance of solution:
  Clear and not more intense in colour than reference solution B₆
• Clarity of solution:
  passes test
• PH (1.0 g in 10 ml water):
  10.5 - 11.5
• Refractive index (n 20/D):
  1.482 - 1.485
• Relative Density (d 20/20):
  1.120 - 1.130
• Relative Density (d 25/25):
  1.120 - 1.128
• Heavy metals (as Pb):
  ≤ 0.0010 %
• As (Arsenic):
  ≤ 0.000075 %
• Fe (Iron):
  ≤ 0.0005 %
• Related substances (Ethanolamine, GC):
  ≤ 0.1 %
• Related substances (Diethanolamine, GC):
  ≤ 0.5 %
• Related substances (total impurity, GC):
  ≤ 1.0 %
• Related substances (N-Nitrosodiethanolamine, GC):
  ≤ 24 ppb
• Residual solvents (ICH Q3C):
  ...excluded by production process
• Sulfated ash (600 °C):
  ≤ 0.05 %
• Water (according to Karl Fischer):
  ≤ 0.5 %
• Endotoxins:
  ≤ 2.5 I.U./ml