Specification Test Results

• Appearance:
  Conforms (see CoA/CoS)
• Heavy metals (as Pb):
  Max. 10 ppm
• Residual solvents (CPMP/ICH/283/95):
  Conforms
• 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. 1 ppm
• Pb (Lead):
  Max. 2 ppm
• V (Vanadium):
  Max. 1 ppm
• Conforms to Ph.Eur./USP:
  Passes test
• Ph.Eur. specifications::
  Max. 0.1 %
• Assay [Ph.Eur.]:
  99.0 --> 100.5 %
• Identification B:
  Passes test Ph.Eur.
• Identification C [Ph.Eur.]:
  2.1 --> 2.6
• Appearance of solution:
  Passes test Ph.Eur.
• Specific optical rotation [Ph.Eur.]:
  20.5 --> 21.5 °
• Impurity E (Oxalic acid) [Ph.Eur.]:
  Max. 0.2 %
• Impurity C [Ph.Eur.]:
  Max. 0.15 %
• Impurity D [Ph.Eur.]:
  Max. 0.15 %
• Unspecified impurities [Ph.Eur.]:
  Max. 0.10 %
• Sum of impur.other than C and D[Ph.Eur.]:
  Max. 0.2 %
• Reporting threshold [Ph.Eur.]::
  Max. 0.05 %
• Cu (Copper) [Ph.Eur.]:
  Max. 5 ppm
• Fe (Iron) [Ph.Eur.]:
  Max. 2 ppm
• Sulphated ash [Ph.Eur.]:
  Max. 0.1 %
• Assay [USP]:
  99.0 --> 100.5 %
• Identification A:
  Passes test USP
• Residue on ignition [USP]:
  Max. 0.1 %
• Specific optical rotation [USP]:
  20.5 --> 21.5 °