Specifikationstestresultat

• Appearance:
  Conforms (see CoA/CoS)
• Heavy metals (as Pb):
  Max. 10 ppm
• Residual solvents Class 2 (ICH Q3C) ::
  Passes test USP
• Methanol:
  Below option 1 limit
• Other residual solvents(Ph.Eur./ICH):
  Unlikely by manuf.process
• Residues of metal catalysts or reagents:
  Unlikely by manuf.process
• As (Arsenic):
  Max. 2 ppm
• Cd (Cadmium):
  Max. 1 ppm
• Co (Cobalt):
  Max. 1 ppm
• Hg (Mercury):
  Max. 2 ppm
• Ni (Nickel):
  Max. 50 ppm
• Pb (Lead):
  Max. 3 ppm
• V (Vanadium):
  Max. 2 ppm
• Conforms to Ph.Eur./USP:
  Passes test
• Ph.Eur. specifications::
  Max. 0.1 %
• Assay (calculated on dried) [Ph.Eur.]:
  99.0 --> 100.5 %
• Identification B [Ph.Eur.]:
  168 --> 174 °C
• Identification C:
  Passes test Ph.Eur.
• Appearance of solution:
  Passes test Ph.Eur.
• pH (20°C; 5 %) [Ph.Eur.]:
  10.0 --> 11.5
• Related substances [Ph.Eur.]:
  Max. 1.0 %
• Cl (Chloride) [Ph.Eur.]:
  Max. 100 ppm
• Fe (Iron) [Ph.Eur.]:
  Max. 10 ppm
• Loss on drying (105°C) [Ph.Eur.]:
  Max. 0.5 %
• Sulphated ash [Ph.Eur.]:
  Max. 0.1 %
• Assay (calculated on dried basis) [USP]:
  99.0 --> 101.0 %
• Identification A:
  Passes test USP
• Identification B:
  Passes test USP
• Residue on ignition [USP]:
  Max. 0.1 %
• Melting range or temperature [USP]:
  168 --> 172 °C
• pH (5 %) [USP]:
  10.0 --> 11.5
• Loss on drying (105°C; 3 h) [USP]:
  Max. 1.0 %