Specification Test Results

• USP - Identification:
  Passes Test
• USP - Loss on Drying at 105°C:
  ≤0.2 %
• USP - Residue on Ignition:
  ≤0.1 %
• USP - Chloride (Cl):
  ≤0.007 %
• USP - Sulfate (SO₄):
  ≤0.0065 %
• USP - Hydrolyzable Substances:
  Passes Test
• USP - Assay (C₂H₅NO₂) (dried basis):
  98.5 - 101.5 %
• USP - Endotoxin Concentration (EU/g):
  ≤2.5
• USP - Related Compounds: Glycine anhydride:
  ≤0.1 %
• USP - Related Compounds: Iminodiacetic acid:
  ≤0.1 %
• USP - Related Compounds: Diglycine:
  ≤0.1 %
• USP - Related Compounds: Triglycine:
  ≤0.1 %
• USP - Related Compounds: Hexamethylenetetramine:
  ≤0.1 %
• USP - Related Compounds: Total impurities:
  ≤1.0 %
• EP/BP - Assay (C₂H₅NO₂) (dried basis):
  98.5 - 101.0 %
• EP/BP - Identification A:
  Passes Test
• EP/BP - Appearance of Solution:
  Passes Test
• EP/BP - pH:
  5.9 - 6.4
• EP/BP - Chloride (Cl):
  ≤75 ppm
• EP/BP - Loss on Drying at 105°C:
  ≤0.5 %
• EP/BP - Ash (sulfated):
  ≤0.1 %
• EP/ BP - Related substances: Glycine anhydride:
  ≤0.10 %
• EP/ BP - Related substances: Diglycine:
  ≤0.10 %
• EP/ BP - Related substances: Triglycine:
  ≤0.10 %
• EP/ BP - Related substances: Unspecified impurities, each:
  ≤0.10 %
• EP/ BP - Related substances: Total impurities:
  ≤0.2 %
• EP/BP - Ninhydrin Positive Substances - Each Impurity:
  ≤0.10 %
• EP/BP-Ninhydrin-Positive Substances-Total Impurities:
  ≤1.0 %
• EP/BP - Ammonium (NH₄):
  ≤0.02 %
• JP - Assay (C₂H₅NO₂) (dried basis):
  98.5 - 101.0 %
• JP - Identification:
  Passes Test
• JP - pH (1 in 20):
  5.6 - 6.6
• 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):
  ≤20 ppm
• JP - Arsenic (As):
  ≤2 ppm
• JP - Related Substances:
  Passes Test
• JP - Loss on Drying at 105°C:
  ≤0.30 %
• JP - Residue on Ignition:
  ≤0.10 %