Specification Test Results

• Meets E.P. Chemical Specifications:
  —
• Meets B.P. Chemical Specifications:
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• Meets N.F. Requirements:
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• GMP Manufactured Product:
  —
• CAUTION: For Manufacturing, processing or repackaging:
  —
• Bulk Pharmaceutical Chemical:
  Passes Test
• NF - Identification A:
  Passes Test
• NF - Identification B:
  Passes Test
• NF - Specific Gravity at 25°/25°C:
  ≤0.789
• NF - Nonvolatile Residue:
  ≤0.004 %
• NF - Readily Oxidizable Substances:
  Passes Test
• NF - Water (H₂O):
  ≤0.5 %
• NF - Assay (as (CH₃)₂CO) (calculated on anhydrous basis):
  99.5 - 100.5 %
• NF - Benzene:
  ≤2 ppm
• EP/BP - Identification A:
  Passes Test
• EP/BP - Identification B:
  Passes Test
• EP/BP - Identification C:
  Passes Test
• EP/BP - Appearance of Solution:
  Passes Test
• EP/BP - Acidity or Alkalinity:
  Passes Test
• EP/BP - Density (g/mL) at 20°C:
  0.790 - 0.793
• EP/BP - Related Substances - Impurity A:
  ≤0.05 %
• EP/BP - Related Substances - Impurity B:
  ≤0.05 %
• EP/BP - Related Substances - Impurity C:
  ≤2 ppm
• EP/BP- Other Impurities:
  ≤0.05 %
• EP/BP - Matter Insoluble in H₂O:
  Passes Test
• EP/BP - Reducing Substances:
  Passes Test
• EP/BP - Residue after Evaporation:
  ≤50 ppm
• EP/BP - Water (H₂O), g/L:
  ≤3 g/l