Specification Test Results

• Assay (acidimetric):
  99.0 − 100.5%
• Assay (HPLC):
  99.0 − 100.5%
• Identity:
  Conforms
• Appearance of solution (5%; water):
  Conforms
• In water insoluble matter:
  ≤0.01%
• Melting range (lower value):
  ≥185.0 °C
• Melting range (upper value):
  ≤190.0 °C
• Melting point:
  185.0 − 190.0 °C
• Chloride (Cl):
  ≤0.001%
• Phosphate (PO₄):
  ≤0.001%
• Sulfate (SO₄):
  ≤0.003%
• Heavy metals (as Pb):
  ≤0.0020%
• Heavy metals (as Pb) (ACS):
  ≤5 ppm
• Nitrogen compounds (as N):
  ≤0.001%
• Fe (Iron):
  ≤5 ppm
• As (Arsenic):
  ≤0.0002%
• Substances reducing permanganate:
  Conforms
• Residual solvents (ICH Q3C):
  Excluded by production process
• Sulfated ash (600 °C):
  ≤0.02%