Specification Test Results

• EP/BP - Assay (C6H9N302 HCl) (dried basis):
  98.5 - 101.0%
• EP/BP - Identification A:
  Passes Test
• EP/BP - Identification B:
  Passes Test
• EP/BP - Identification C:
  Passes Test
• EP/BP - Identification F:
  Passes Test
• EP/BP - Appearance of Solution:
  Passes Test
• EP/BP - pH:
  3.0 - 5.0
• EP/BP - Specific Rotation (.A]2°AO (+):
  9.2 - 10.6°
• 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 Drying at 150 °C:
  7.0 - 10.0%
• EP/BP - Ash (sulfated):
  ≤0.1%
• JP - Identification:
  Passes Test
• JP - 0ptical Rotation (+):
  9.2 - 10.6
• JP - pH:
  3.5 - 4.5
• JP - Clarity and Color of Solution:
  Passes Test
• JP - Sulfate (S04):
  ≤0.028%
• JP - Ammonium (NH4):
  ≤0.02%
• JP - Iron (Fe):
  ≤10 ppm
• JP - Related Substances:
  Passes Test
• JP - Water:
  7.2 - 10.0%
• JP - Residue on Ignition:
  ≤0.10%
• JP - Assay (anhydrous basis):
  99.0 - 101.0%
• ChP - Specific Rotation @ 20 °C:
  8.5 - 10.5°
• ChP - Identification 1 (TLC):
  Passes Test
• ChP - Identification 2 (IR):
  Passes Test
• ChP - Acidity or alkalinity (pH):
  3.5 - 4.5
• ChP - Transmittance of solution:
  ≥ 98.0%
• ChP - Chloride Content:
  16.7 - 17.1%
• ChP - Sulfates:
  ≤0.02%
• ChP - Ammonium:
  ≤0.02%
• ChP - 0ther amino acids (TLC)(<=0.2%, one spot only):
  Passes Test
• ChP - Loss on drying @ 105 °C:
  ≤0.2%
• ChP - Residue on ignition:
  ≤0.1%
• ChP - Heavy metals:
  ≤0.001%
• ChP - Arsenic:
  ≤0.0001%
• ChP - Bacterial endotoxin, EU/g:
  ≤6.0
• ChP - Assay, dried basis:
  99.0 - 101.0%
• ChP - Iron:
  ≤0.001%