Specification Test Results

• Meets J.P. Chemical Specifications:
  Passes Test
• GMP Manufactured Product:
  ≤0.10%
• Meets U.S.P Requirements:
  ≤0.10%
• Meets B.P. Chemical Specifications:
  Passes Test
• Meets E.P. Chemical Specifications:
  99.0 - 101.0%
• CAUTION: For Manufacturing, processing or repackaging:
  ≥1.249
• Bulk Pharmaceutical Chemical:
  Passes Test
• USP - Identification A:
  Passes Test
• USP - Identification B - Diethylene Glycol:
  ≤0.10 %
• USP - Identification B - Ethylene Glycol:
  ≤0.10 %
• USP - Identification C:
  Passes Test
• USP - Assay (as HOCH₂CHOHCH₂OH) (calculated on anhydrous basis):
  99.0 - 101.0 %
• USP - Specific Gravity at 25°/25°C:
  ≥1.249
• USP - Color:
  Passes Test
• USP - Residue on Ignition:
  ≤0.01 %
• USP - Chloride (Cl):
  ≤0.001 %
• USP - Sulfate (SO₄):
  ≤0.002 %
• USP - Chlorinated Compounds (as Cl):
  ≤0.003 %
• USP - Fatty Acids and Esters:
  Passes Test
• USP - Water (H₂O):
  ≤5.0 %
• USP - Related Compounds: Individual Impurity:
  ≤0.1 %
• USP - Related Compo unds: Total Impurities:
  ≤1.0 %
• EP/BP - Identification A:
  Passes Test
• EP/BP - Identification B:
  Passes Test
• EP/BP - Appearance of Solution:
  Passes Test
• EP/BP - Acidity or Alkalinity:
  Passes Test
• EP/BP - Refractive Index, n²ºD:
  1.470 - 1.475
• EP/BP - Aldehydes:
  ≤10 ppm
• EP/BP - Ester:
  Passes Test
• EP/BP - Halogenated Compounds:
  ≤35 ppm
• EP/BP - Sugars:
  Passes Test
• EP/BP - Chloride (Cl):
  ≤10 ppm
• EP/BP - Water (H₂O):
  ≤2.0 %
• EP/BP - Ash (sulfated):
  ≤0.01 %
• EP/BP - Impurity A and Related Substances - Impurity A:
  ≤0.1 %
• EP/BP - Impurity A and Related Substances - Other Impurities with R^T
  ≤0.1 %
• EP/BP - Impurity A and Related Substances - Total Impurities R^T>Glycerol:
  ≤0.5 %
• EP - Assay (anhydrous basis):
  98.0 - 101.0 %
• JP - Assay (anhydrous basis):
  98.0 - 101.0 %
• JP - Identification:
  Passes Test
• JP - Specific Gravity at 20°/20°C:
  ≥1.258
• JP - Refractive Index, n²ºD:
  ≥1.470
• JP - Color:
  Passes Test
• JP - Residue on Ignition:
  ≤0.01 %
• JP - Chloride (Cl):
  ≤0.001 %
• JP - Sulfate (SO₄):
  ≤0.002 %
• JP - Heavy Metals (as Pb):
  ≤5 ppm
• JP - Fatty Acids and Esters(as butyric acid):
  Passes Test
• JP - Readily Carbonizable Substances:
  Passes Test
• JP - Acidity or Alkalinity:
  Passes Test
• JP - Acrolein, Glucose, and Other Reducing Substances:
  Passes Test
• JP - Ammonium (NH₄):
  Passes Test
• JP - Calcium (Ca):
  Passes Test
• JP - Arsenic (As):
  ≤2 ppm
• JP - Water (H₂O):
  ≤2.0 %
• JP - Ethylene Glycol:
  ≤0.1 %
• JP - Diethylene Glycol:
  ≤0.1 %
• JP - Any Other Impurity:
  ≤0.1 %
• JP - Total Impurities:
  ≤1.0 %
• Endotoxin Concentration (EU/g):
  ≤5