Specification Test Results

• Assay (alkalimetric):
  99.8 - 100.5 %
• Identity:
  passes test
• Colour (Hazen):
  ≤ 10 Hazen
• Appearance of the substance:
  passes test
• Formic acid, Formates and other oxidable impurities (as HCOOH):
  ≤ 0.5 %
• Titratable base:
  ≤ 0.0004 meq/g
• Solidification temperature:
  ≥ 16.3 °C
• Chloride (Cl):
  ≤ 2 ppm
• Sulfate (SO₄):
  ≤ 5 ppm
• Heavy metals (as Pb):
  ≤ 5 ppm
• Fe (Iron):
  ≤ 0.2 ppm
• Other residual solvents (ICH Q3C):
  ...excluded by production process
• Reducing substances (Ph Eur):
  passes test
• Substances reducing potassium permanganate:
  passes test
• Evaporation residue:
  ≤ 50 ppm
• Dilution test:
  passes test
• Endotoxins:
  ≤ 2.5 I.U./ml