Specification Test Results

• USP - Assay (C₄H₈NO₃) (dried basis):
  98.5 - 101.5 %
• USP - Identification:
  Passes Test
• USP - Specific Rotation [Å]²⁵ ^D:
  -29.1 - -26.7 Degree
• USP - pH:
  5.0 - 6.5
• USP - Loss on Drying at 105°C:
  ≤0.2 %
• USP - Residue on Ignition:
  ≤0.4 %
• USP - Chloride (Cl):
  ≤0.05 %
• 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 (C₄H₈NO₃) (dried basis):
  99.0 - 101.0 %
• EP/BP - Identification A:
  Passes Test
• EP/BP - Identification B:
  Passes Test
• EP/BP - Appearance of Solution:
  Passes Test
• EP/BP - pH:
  5.0 - 6.5
• EP/BP - Specific Rotation [Å]²º^D:
  -29.0 - -27.6 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 - Assay (C₄H₈NO₃) (dried basis):
  98.5 - 101.0 %
• JP - Identification:
  Passes Test
• JP - Optical Rotation:
  -29.0 - -26.0 Degree
• JP - pH:
  5.2 - 6.2
• 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:
  ≤0.20 %
• JP - Residue on Ignition:
  ≤0.10 %