Specification Test Results

• Appearance:
  Conforms (see CoA/CoS)
• Heavy metals (as Pb):
  ≤10 ppm
• Residual solvents:
  Unlikely by manuf.process
• As (Arsenic):
  ≤2 ppm
• Cd (Cadmium):
  ≤1 ppm
• Co (Cobalt):
  ≤1 ppm
• Hg (Mercury):
  ≤3 ppm
• Ni (Nickel):
  ≤1 ppm
• Pb (Lead):
  ≤4 ppm
• V (Vanadium):
  ≤5 ppm
• Conforms to Ph.Eur./USP/BP:
  Passes test
• Ph.Eur./BP specifications::
  .
• Assay (dried substance) [Ph.Eur./BP]:
  98.0 - 100.5 %
• Identification A:
  Passes test Ph.Eur./BP
• Identification B:
  Passes test Ph.Eur./BP
• Identification C:
  Passes test Ph.Eur./BP
• Appearance of solution:
  Passes test Ph.Eur./BP
• pH (5 %) [Ph.Eur./BP]:
  4.2 - 4.5
• Reducing substances:
  Passes test Ph.Eur./BP
• Cl (Chloride) [Ph.Eur./BP]:
  ≤200 ppm
• SO4 (Sulphate) [Ph.Eur./BP]:
  ≤300 ppm
• Fe (Iron) [Ph.Eur./BP]:
  ≤10 ppm
• Loss on drying (130°C) [Ph.Eur./BP]:
  21.5 - 24.0 %
• USP specifications::
  .
• Assay (calculated on anhydrous) [USP]:
  98.0 - 103.0 %
• Insoluble substances [USP]:
  ≤0.2 %
• Cl (Chloride) [USP]:
  ≤0.014 %
• SO4 (Sulphate) [USP]:
  ≤0.15 %
• Al, Ca and related elements:
  Passes test USP
• As (Arsenic) [USP]:
  ≤8 ppm
• pH (25°C; 1 g/20 ml) [USP]:
  4.1 - 4.5
• Water determination [USP]:
  18.0 - 26.5 %