Specification Test Results

• Meets U.S.P Requirements:
• GMP Manufactured Product:
• Meets J.P. Chemical Specifications:
• Meets E.P. Chemical Specifications:
• Meets B.P. Chemical Specifications:
• IMPORTANT: Material will freeze if stored below 17 °C (63°F).:
• CAUTION: For Manufacturing, processing or repackaging:
• Bulk Pharmaceutical Chemical:
• USP - Identification:
  Passes Test
• USP - Congealing Temperature:
  ≥15.6 °C
• USP - Nonvolatile Residue (USP), mg/20 mL:
  ≤1.0
• USP - Chloride (Cl):
  Passes Test
• USP - Sulfate (SO₄):
  Passes Test
• USP - Readily Oxidizable Substances:
  Passes Test
• USP - Assay (CH₃COOH):
  99.5 - 100.5 %
• EP/BP - Identification A:
  Passes Test
• EP/BP - Identification B:
  Passes Test
• EP/BP - Appearance:
  Passes Test
• EP/BP - Freezing Point:
  ≥14.8 °C
• EP/BP - Iron (Fe):
  ≤5 ppm
• EP/BP - Chloride (Cl):
  ≤25 ppm
• EP/BP - Sulfate (SO₄):
  ≤50 ppm
• EP/BP - Reducing Substances:
  Passes Test
• EP/BP - Residue on Evaporation:
  ≤0.01 %
• EP/BP - Assay (CH₃COOH):
  99.0 - 100.5 %
• JP - Assay (CH₃COOH):
  99.0 - 101.0 %
• JP - Identification:
  Passes Test
• JP - Congealing Point:
  ≥14.5 °C
• JP - Nonvolatile Residue, mg/10 mL:
  ≤1.0
• JP - Chloride (Cl):
  Passes Test
• JP - Sulfate (SO₄):
  Passes Test
• JP - Heavy Metals (as Pb):
  ≤10 ppm
• JP - Reducing Substances:
  Passes Test
• Residual Solvents: No Class 1, 2 or 3 residual solvents are used in or:
• produced by the production process.:
• Preserve in tight containers, and store at room temperature:
• Elemental Impurities (USP 232, EP 5.20) - Information on elemental:
• impurities for this product is available on the associated Product:
• Regulatory Data Sheet and elemental impurity profile report.:
• J.T.Baker®, Acetic acid glacial 99.5-100.05% USP, Multi-Compendial: