Specification Test Results

• Meets U.S.P Requirements:
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• Meets J.P. Chemical Specifications:
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• Meets B.P. Chemical Specifications:
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• Meets E.P. Chemical Specifications:
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• GMP Manufactured Product:
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• CAUTION: For Manufacturing, processing or repackaging:
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• Bulk Pharmaceutical Chemical:
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• USP - Specific Gravity at 25°/25°C:
  1.035 - 1.037
• USP - Acidity:
  Passes Test
• USP - Water (H2O)(by Karl Fischer titrn):
  ≤ 0.20 %
• USP - Identification A (IR):
  Passes Test
• USP - Identification B - Diethylene Glycol:
  ≤ 0.10 %
• USP - Identification B - Ethylene Glycol:
  ≤ 0.10 %
• USP - Identification C:
  Passes Test
• USP - Residue on Ignition:
  ≤ 0.007 %
• USP - Chloride (Cl):
  ≤ 0.007 %
• USP - Sulfate (SO₄):
  ≤ 0.006 %
• USP - Assay (CH₃CHOHCH₂OH):
  ≥ 99.5 %
• Endotoxin Concentration (EU/g):
  ≤ 2.5
• EP/BP - Relative Density (d²º₂₀):
  1.035 - 1.040
• EP/BP - Refractive Index at 20°C:
  1.431 - 1.433
• EP/BP - Identification A:
  Passes Test
• EP/BP - Identification B:
  Passes Test
• EP/BP - Identification C:
  Passes Test
• EP/BP - Identification D:
  Passes Test
• EP/BP - Appearance:
  Passes Test
• EP/BP - Acidity:
  Passes Test
• EP/BP - Oxidizing Substances:
  Passes Test
• EP/BP - Reducing Substances:
  Passes Test
• EP/BP - Water (H₂O):
  ≤ 0.2 %
• EP/BP - Ash (sulfated):
  ≤ 0.01 %
• JP - Identification A:
  Passes Test
• JP - Identification B:
  Passes Test
• JP - Specific Gravity at 20°/20°C:
  1.035 - 1.040
• JP - Acidity:
  Passes Test
• JP - Chloride (Cl):
  ≤ 0.007 %
• JP - Sulfate (SO₄):
  ≤ 0.002 %
• JP - Heavy Metals (as Pb):
  ≤ 5 ppm
• JP - Arsenic (As):
  ≤ 2 ppm
• JP - Glycerin:
  Passes Test
• JP - Water (H₂O):
  ≤ 0.5 %
• JP - Residue on Ignition:
  ≤ 0.005 %
• JP - Distilling Range (Lower):
  184 - 189 °C
• JP - Distilling Range (Upper):
  184 - 189 °C
• JP - Ethylene Glycol:
  ≤ 0.1 %
• JP - Diethylene Glycol:
  ≤ 0.1 %
• JP - Any Other Impurity:
  ≤ 0.1 %
• JP - Total Impurities:
  ≤ 1.0 %