Specification Test Results

• Assay (Titrimetric, Calculated on Dried Substance):
  99.5 - 100.5%
• Assay (Titrimetric):
  99.0 - 100.5%
• Identity:
  Passes Test
• pH (3.3%; H₂O):
  3.8 - 4.8
• Loss on Drying:
  Max. 0.5%
• Residue on Ignition (CH₃OH + HCl):
  Max. 0.1%
• Residual Solvents (Ph. Eur./USP):
  Passes Test
• Organic Substances:
  Passes Test
• Sulphate:
  Max. 0.045%
• Phosphate:
  Max. 0.002%
• Chloride:
  Max. 0.002%
• As:
  Max. 0.0005%
• Fe:
  Max. 0.001%
• PB:
  Max. 0.001%
• Cu:
  Max. 0.001%
• MG:
  Max. 0.005%
• Ni:
  Max. 0.001%
• Class 1 (Cd) - ICH Q3D:
  Max. 0.5 ppm
• Class 2B (Au) - ICH Q3D:
  Max. 10 ppm
• Class 1 (As) - ICH Q3D:
  Max. 1.5 ppm
• Class 1 (Hg) - ICH Q3D:
  Max. 1.5 ppm
• Class 2A (V) - ICH Q3D:
  Max. 10 ppm
• Class 2A (Ni) - ICH Q3D:
  Max. 20 ppm
• Class 2B (Ru) - ICH Q3D:
  Max.10 ppm
• Class 2B (Pt) - ICH Q3D:
  Max. 10 ppm
• Class 2B (Se) - ICH Q3D:
  Max. 15 ppm
• Class 2B (Ag) - ICH Q3D:
  Max. 15 ppm
• Class 3 (Sb) - ICH Q3D:
  Max. 120 ppm
• Class 3 (Sn) - ICH Q3D:
  Max. 600 ppm
• Class 2B (Rh) - ICH Q3D:
  Max. 10 ppm
• Class 2A (Co) - ICH Q3D:
  Max. 5 ppm
• Class 3 (Li) - ICH Q3D:
  Max. 55 ppm
• Class 1 (Pb) - ICH Q3D:
  Max. 0.5 ppm
• Class 2B (Tl) - ICH Q3D:
  Max. 0.8 ppm
• Class 2B (Pd) - ICH Q3D:
  Max. 10 ppm
• Class 2B (Ir) - ICH Q3D:
  Max. 10 ppm
• Class 2B (Os) - ICH Q3D:
  Max. 10 ppm
• Class 3 (Ba) - ICH Q3D:
  Max. 140 ppm
• Class 3 (Mo) - ICH Q3D:
  Max. 25 ppm
• Class 3 (Cr) - ICH Q3D:
  Max. 25 ppm
• Class 3 (Cu) - ICH Q3D:
  Max. 250 ppm