Specification Test Results

• Meets E.P. Chemical Specifications:
• Meets N.F. Requirements:
• GMP Manufactured Product:
• CAUTION: For Manufacturing, processing or repackaging:
• Bulk Pharmaceutical Chemical:
• NF - Assay (CH₃0H) (by GC):
  ≥99.5 %
• NF - Identification A:
  Passes Test
• NF - Identification B:
  Passes Test
• NF - Acidity:
  Passes Test
• NF - Alkalinity (as NH₃):
  ≤3 ppm
• NF - Nonvolatile Residue:
  ≤0.001 %
• NF - Readily Carbonizable Substances:
  Passes Test
• NF - Readily Oxidizable Substances:
  Passes Test
• NF - Acetone, Aldehydes (as (CH₃)₂CO):
  ≤0.003 %
• NF - Water (H₂O):
  ≤0.1 %
• EP - Identification A:
  Passes Test
• EP - Identification B:
  Passes Test
• EP/BP - Appearance:
  Passes Test
• EP - Acidity or Alkalinity:
  Passes Test
• EP - Relative Density:
  0.791 - 0.793
• EP - Absorbance at 230 nm (au):
  ≤0.15
• EP - Absorbance at 250 nm (au):
  ≤0.050
• EP - Absorbance at 270 nm (au):
  ≤0.020
• EP - Absorbance at 290 nm (au):
  ≤0.010
• EP - Scan from 230 nm to 290 nm:
  Passes Test
• EP/BP - Impurity A (Benzene):
  ≤2 ppm
• EP - Related Substances - Single Impurity Peak:
  ≤0.1 %
• EP - Related Substances - Total of All Impurity Peaks:
  ≤0.3 %
• EP/BP - Reducing Substances:
  Passes Test
• EP/BP - Residue on Evaporation:
  ≤10 ppm
• EP - Water:
  ≤0.10 %
• Appearance (clear, colorless liquid):
• Only Class 3 Solvents are likely to be present. Residual concentration:
• of all Class 3 Solvents is <0.5%.:
• 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.:
• Methanol ≥99.5% (by GC), GenAR® NF, Macron Fine Chemicals™: