Specification Test Results

• USP - Assay (C6H14N402·HCl) (dried basis):
  98.5 - 101.5%
• USP - Identification:
  Passes Test
• USP - Specific Rotation (A]2°AO (+):
  21.4 - 23.6°
• USP - Loss on Orying at 105 °C:
  ≤0.2%
• USP - Residue on Ignition:
  ≤0.1%
• USP - Sulfate (S04):
  ≤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 (C6H14N402·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 (A]2°AO (+):
  21.0 - 23.5°
• EP/BP-Ninhydrin-Positive Substances-Each:
  ≤0.2%
• EP/BP-Ninhydrin-Positive Substances-Total Impurities:
  ≤0.5%
• EP/BP - Sulfate (S04):
  ≤300 ppm
• EP/BP - Ammonium (NH4):
  ≤0.02%
• EP/BP - Iron (Fe):
  ≤10 ppm
• EP/BP - Loss on Orying:
  ≤0.5%
• EP/BP - Ash (sulfated):
  ≤0.1%
• JP - Assay (C6H14N402·HCl) (dried basis):
  98.5 - 101.0%
• JP - Identification:
  Passes Test
• JP - 0ptical Rotation (+):
  21.5 - 23.5°
• JP - pH (1 in 10):
  4.7 - 6.2
• JP - Clarity and Color of Solution:
  Passes Test
• JP - Sulfate (S04):
  ≤0.028%
• JP - Ammonium (NH4):
  ≤0.02%
• JP - Arsenic (As):
  ≤2 ppm
• JP - Related Substances:
  Passes Test
• JP - Loss on Orying at 105 °C:
  ≤0.20%
• JP - Residue after Ignition:
  ≤0.10%
• ChP - Transmittance of solution:
  ≥ 98.0%
• ChP - Sulfates:
  ≤0.02%
• ChP - Ammonium:
  ≤0.02%
• ChP - Loss on drying @ 105 °C:
  ≤0.2%
• ChP - Residue on ignition:
  ≤0.1%
• ChP - Heavy metals:
  ≤0.001%
• ChP - Arsenic:
  ≤0.0001%
• ChP - Identification 1 (TLC):
  Passes Test
• ChP - Identification 2 (IR):
  Passes Test
• ChP - Chloride Content:
  16.5 - 17.1%
• ChP - 0ther amino acids (TLC)(<=0.2%, one spot only):
  Passes Test
• ChP - Proteins:
  Passes Test
• ChP - Iron:
  ≤0.001%
• ChP - Specific Rotation @ 20 °C (+):
  21.5 - 23.5
• ChP - Phosphates:
  ≤0.02%
• ChP - Assay (dried basis):
  98.5 - 101.0%