Specification Test Results

• USP - Identification A:
  Passes Test
• USP - Identification B:
  Passes Test
• USP - Assay (NH₂CONH₂):
  98.0 - 102.0 %
• USP - Residue on Ignition:
  ≤0.1 %
• USP - Alcohol Insoluble Matter:
  ≤0.04 %
• USP - Organic impurities: Urea related compound A:
  ≤0.1 %
• USP - Organic impurities: Any individual unspecified impurity:
  ≤0.1 %
• USP - Organic impurities: Total impurities:
  ≤2.0 %
• USP - Endotoxin Concentration (EU/g):
  ≤2.5
• EP/BP - Assay (NH₂CONH₂) (dried basis):
  98.5 - 101.5 %
• EP/BP - Identification A:
  Passes Test
• EP/BP - Identification B:
  Passes Test
• EP/BP - Appearance of Solution:
  Passes Test
• EP/BP - Alkalinity:
  Passes Test
• EP/BP - Biuret:
  ≤0.1 %
• EP/BP - Ammonium (NH₄):
  ≤500 ppm
• EP/BP - Loss on Drying at 105°C:
  ≤1.0 %
• EP/BP - Ash (sulfated):
  ≤0.1 %
• JP - Assay (NH₂CONH₂):
  99.0 - 101.0 %
• JP - Identification A:
  Passes Test
• JP - Identification B:
  Passes Test
• JP - Chloride (Cl):
  ≤0.007 %
• JP - Sulfate (SO₄):
  ≤0.010 %
• JP - Heavy Metals (as Pb):
  ≤20 ppm
• JP - Alcohol Insoluble Matter:
  ≤0.040 %
• JP - Residue on Ignition:
  ≤0.10 %
• JP - Melting Point:
  132.5 - 134.5 °C