Specification Test Results

• Assay (HPLC):
  98.0 - 102.0%
• Assay (ex N):
  99.0 - 100.5%
• Assay (ex N, Calculated on Dried Substance):
  99.0 - 101.0%
• Identity:
  Conforms
• In Ethanol (96%) Insoluble Parts:
  ≤0.04%
• Alkalinity:
  Passes Test
• Chloride (Cl):
  ≤0.007%
• Sulfate (SO₄):
  ≤0.010%
• Heavy Metals (as Pb):
  ≤0.0010%
• NH₄ (Ammonium):
  ≤0.0500%
• Biuret:
  ≤0.1%
• Organic Impurities (Related compound A):
  ≤0.1%
• Organic Impurities (Any Individual Unspecified Impurity):
  ≤0.1%
• Organic Impurities (Total Impurities):
  ≤2.0%
• Residual Solvents (ICH Q3C):
  Excluded by Manufacturing Process
• Sulfated Ash (600 °C):
  ≤0.10%
• Loss on Drying (105 °C):
  ≤1.0%