Specification Test Results

• USP - Assay (C₆H₁₄N₄O₂·HCl) (dried basis):
  98.5 - 101.5 %
• USP - Identification:
  Passes Test
• USP - Specific Rotation [Å]²º^D (+):
  21.4 - 23.6 Degree
• USP - Loss on Drying at 105°C:
  ≤0.2 %
• USP - Residue on Ignition:
  ≤0.1 %
• USP - Sulfate (SO₄):
  ≤0.03 %
• USP - Related Compounds - Individual Impurities:
  ≤0.5 %
• USP - Related Compounds - Total Impurities:
  ≤2.0 %
• USP - Chloride (Cl):
  16.5 - 17.1 %
• EP/BP - Assay (C₆H₁₄N₄O₂·HCl) (dried basis):
  98.5 - 101.0 %
• EP/BP - Identification A:
  Passes Test
• EP/BP - Identification B:
  Passes Test
• EP/BP - Identification E:
  Passes Test
• EP/BP - Appearance of Solution:
  Passes Test
• EP/BP - Specific Rotation [Å]²º^D (+):
  21.0 - 23.5 Degree
• EP/BP-Ninhydrin-Positive Substances-Each:
  ≤0.2 %
• EP/BP-Ninhydrin-Positive Substances-Total Impurities:
  ≤0.5 %
• EP/BP - Sulfate (SO₄):
  ≤300 ppm
• EP/BP - Ammonium (NH₄):
  ≤0.02 %
• EP/BP - Iron (Fe):
  ≤10 ppm
• EP/BP - Loss on Drying:
  ≤0.5 %
• EP/BP - Ash (sulfated):
  ≤0.1 %
• JP - Assay (C₆H₁₄N₄O₂·HCl) (dried basis):
  98.5 - 101.0 %
• JP - Identification:
  Passes Test
• JP - Optical Rotation (+):
  21.5 - 23.5 Degree
• JP - pH (1 in 10):
  4.7 - 6.2
• JP - Clarity and Color of Solution:
  Passes Test
• JP - Sulfate (SO₄):
  ≤0.028 %
• JP - Ammonium (NH₄):
  ≤0.02 %
• JP - Heavy Metals (as Pb):
  ≤20 ppm
• JP - Arsenic (As):
  ≤2 ppm
• JP - Related Substances:
  Passes Test
• JP - Loss on Drying at 105°C:
  ≤0.20 %
• JP - Residue after Ignition:
  ≤0.10 %