Specification Test Results

• USP - Assay (C₆H₅Na₃O₇) (anhydrous basis):
  99.0 - 100.5 %
• USP - Alkalinity:
  Passes Test
• USP - Identification A:
  Passes Test
• USP - Identification B:
  Passes Test
• USP - Identification C:
  Passes Test
• USP - Tartrate:
  Passes Test
• USP - Water (H₂O):
  10.0 - 13.0 %
• EP/BP - Assay (C₆H₅Na₃O₇) (calculated on the anhydrous basis):
  99.0 - 101.0 %
• EP/BP - Identification A:
  Passes Test
• EP/BP - Identification B:
  Passes Test
• EP/BP - Acidity or Alkalinity:
  Passes Test
• EP/BP - Chloride (Cl):
  ≤50 ppm
• EP/BP - Oxalate (C₂O₄):
  ≤300 ppm
• EP/BP - Sulfate (SO₄):
  ≤150 ppm
• EP/BP - Readily Carbonizable Substances:
  Passes Test
• EP/BP - Water (H₂O):
  11.0 - 13.0 %
• EP/BP - Appearance of Solution:
  Passes Test
• Endotoxin Concentration (EU/g):
  ≤5
• JP - Assay (anhydrous basis):
  99.0 - 101.0 %
• JP - pH (1 in 20):
  7.5 - 8.5
• JP - Clarity and Color of Solution:
  Passes Test
• JP - Chloride (Cl):
  ≤0.015 %
• JP - Identification:
  Passes Test
• JP - Sulfate (SO₄):
  ≤0.048 %
• JP - Heavy Metals (as Pb):
  ≤10 ppm
• JP - Arsenic (As):
  ≤2 ppm
• JP - Tartrate:
  Passes Test
• JP - Oxalate (C₂O₄):
  Passes Test
• JP - Readily Carbonizable Substances:
  Passes Test
• JP - Loss on Drying at 180°C:
  10.0 - 13.0 %