Specifikationstestresultat

• Assay (Compl.) (calc. A.A.S):
  99.0 - 100.5%
• Identity: Identity according to Pharmacopoeias:
  Passes Test
• pH of 5% Solution:
  5.0 - 9.2
• Appearance of solution:
  Passes Test
• Maximum Limit of Impurities, Acidity or Alkalinity:
  Passes Test
• Maximum Limit of Impurities, Insoluble Matter In H₂O:
  0.025 %
• Maximum Limit of Impurities, Loss on Drying at 450°C:
  48.0 - 52.0 %
• Maximum Limit of Impurities, Chloride (Cl):
  0.014%
• Maximum Limit of Impurities, Ammonium (NH₄):
  0.005%
• Maximum Limit of Impurities, Phosphate (PO₄):
  0.002 %
• Maximum Limit of Impurities, Residual Solvents (Ph. Eur./USP):
  passes test
• Maximum Limit of Impurities, Heavy Metals (as Pb):
  0.001%
• Maximum Limit of Impurities, Fe:
  0.002 %
• Maximum Limit of Impurities, Se:
  0.0015 %
• Maximum Limit of Impurities, As:
  0.00015 %
• Elemental Impurities (ICH Q3D), Class 1, Cd:
  0.5 ppm
• Elemental Impurities (ICH Q3D), Class 1, Pb:
  50 ppm
• Elemental Impurities (ICH Q3D), Class 1, As:
  1.5 ppm
• Elemental Impurities (ICH Q3D), Class 1, Hg:
  1.5 ppm
• Elemental Impurities (ICH Q3D), Class 2A, Co:
  5 ppm
• Elemental Impurities (ICH Q3D), Class 2A, V:
  10 ppm
• Elemental Impurities (ICH Q3D), Class 2A, Ni:
  20 ppm
• Elemental Impurities (ICH Q3D), Class 2B, Au:
  10 ppm
• Elemental Impurities (ICH Q3D), Class 2B, Pd:
  10 ppm
• Elemental Impurities (ICH Q3D), Class 2B, Ir:
  10 ppm
• Elemental Impurities (ICH Q3D), Class 2B, Os:
  10 ppm
• Elemental Impurities (ICH Q3D), Class 2B, Rh:
  10 ppm
• Elemental Impurities (ICH Q3D), Class 2B, Ru:
  10 ppm
• Elemental Impurities (ICH Q3D), Class 2B, Se:
  15 ppm
• Elemental Impurities (ICH Q3D), Class 2B, Ag:
  15 ppm
• Elemental Impurities (ICH Q3D), Class 2B, Pt:
  10 ppm
• Elemental Impurities (ICH Q3D), Class 3, Li:
  55 ppm
• Elemental Impurities (ICH Q3D), Class 3, Sb:
  120 ppm
• Elemental Impurities (ICH Q3D), Class 3, Ba:
  140 ppm
• Elemental Impurities (ICH Q3D), Class 3, Mo:
  25 ppm
• Elemental Impurities (ICH Q3D), Class 3, Cu:
  250 ppm
• Elemental Impurities (ICH Q3D), Class 3, Sn:
  600 ppm
• Elemental Impurities (ICH Q3D), Class 3, Cr:
  25 ppm