Specification Test Results

• USP - Assay (C₆H₁₄N₄O₂) (dried basis):
  98.5 - 101.5 %
• USP - Identification:
  Passes Test
• USP - Specific Rotation [Å]²⁵ ^D (+):
  26.3 - 27.7 Degree
• USP - Loss on Drying at 105°C:
  ≤ 0.5 %
• USP - Chloride (Cl):
  ≤ 0.05 %
• USP - Residue on Ignition:
  ≤ 0.3 %
• USP - Sulfate (SO₄):
  ≤ 0.03 %
• USP - Iron (Fe):
  ≤ 0.003 %
• USP - Related Compounds - Individual Impurities:
  ≤ 0.5 %
• USP - Related Compounds - Total Impurities:
  ≤ 2.0 %
• EP/BP - Assay (C₆H₁₄N₄O₂) (dried basis):
  98.5 - 101.0 %
• EP/BP - Identification A:
  Passes Test
• EP/BP - Identification C:
  Passes Test
• EP/BP - Appearance of Solution:
  Passes Test
• EP/BP - Specific Rotation [Å]²º^D (+):
  25.5 - 28.5 Degree
• EP/BP-Ninhydrin-Positive Substances-Each:
  ≤ 0.2 %
• EP/BP-Ninhydrin-Positive Substances-Total Impurities:
  ≤ 0.5 %
• EP/BP - Chloride (Cl):
  ≤ 200 ppm
• 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 - Identification:
  Passes Test
• JP - Optical rotation, 20° C (+):
  26.9 - 27.9 Degree
• JP - pH (1:10):
  10.5 - 12.0
• JP - Clarity and Color of Solution:
  Passes Test
• JP - Chloride (Cl):
  ≤ 0.021 %
• JP - Sulfate (SO₄):
  ≤ 0.028 %
• JP - Ammonium (NH₄):
  ≤ 0.02 %
• JP - Heavy Metals (as Pb):
  ≤ 10 ppm
• JP - Iron (Fe):
  ≤ 10 ppm
• JP - Related Substances:
  Passes Test
• JP - Loss on Drying at 105°C:
  ≤ 0.30 %
• JP - Residue after Ignition:
  ≤ 0.1 %
• JP - Assay (C₆H₁₄N₄O₂)(dried basis):
  98.5 - 101.0 %