Specification Test Results

• Meets E.P. Chemical Specifications:
  88.0 - 92.0%
• GMP Manufactured Product:
  Passes Test
• Meets U.S.P Requirements:
  Passes Test
• CAUTION: For Manufacturing, processing or repackaging:
  Passes Test
• Bulk Pharmaceutical Chemical:
  Passes Test
• USP - Assay (CH₃CHOHCOOH):
  88.0 - 92.0 %
• USP - Chloride (Cl):
  Passes Test
• USP - Citric, Oxalic, Phosphoric, or Tartaric Acids:
  Passes Test
• USP - Identification:
  Passes Test
• USP - Readily Carbonizable Substances:
  Passes Test
• USP - Residue on Ignition:
  ≤ 0.05 %
• USP - Sugars:
  Passes Test
• USP - Sulfate (SO₄):
  Passes Test
• EP - Assay (CH₃CHOHCOOH):
  88.0 - 92.0 %
• EP - Appearance:
  Passes Test
• EP - (S)-enantiomer:
  ≥ 95.0 %
• EP - Calcium (Ca):
  ≤ 200 ppm
• EP - Citric, Oxalic, and Phosphoric Acids:
  Passes Test
• EP - Endotoxin Concentration, <5 IU/g:
  Passes Test
• EP - Ether-Insoluble Substances:
  Passes Test
• EP - Identification A:
  Passes Test
• EP - Identification B:
  Passes Test
• EP - Identification C:
  Passes Test
• EP - Methanol (by GC):
  ≤ 50 ppm
• EP - Sugars and Other Reducing Substances:
  Passes Test
• EP - Sulfate (SO₄):
  ≤ 200 ppm
• EP - Sulfated Ash:
  ≤ 0.1 %
• JP - Assay (CH₃CHOHCOOH):
  85.0 - 92.0 %
• JP - Chloride (Cl):
  ≤ 0.036 %
• JP - Citric, Oxalic, Phosphoric, or Tartaric Acids:
  Passes Test
• JP - Cyanide (CN):
  Passes Test
• JP - Glycerin and Mannitol:
  Passes Test
• JP - Heavy Metals (as Pb):
  ≤ 10 ppm
• JP - Identification:
  Passes Test
• JP - Iron (Fe):
  ≤ 5 ppm
• JP - Readily Carbonizable Substances:
  Passes Test
• JP - Residue on Ignition:
  ≤ 0.10 %
• JP - Sugars:
  Passes Test
• JP - Sulfate (SO₄):
  ≤ 0.010 %
• JP - Volatile Fatty Acids:
  Passes Test
• JP - Optical Rotation:
  -52 - -46 Degree