Specifikationstestresultat

• Assay (Alkalimetric, Calculated on Anhydrous Substance):
  98.5 - 100.5%
• Assay (GC, calc. on anhydrous substance):
  97.0 - 102.0%
• Identity (IR-spectrum):
  Passes Test
• Identity (GC):
  Passes Test
• Appearance:
  Clear Colorless, Slightly Viscous Liquid, not more Intense in Color than Reference Solution Y₆
• Acidity (Ph. Eur./ USP):
  passes test
• Refractive Index (n 20/D):
  1.430 - 1.432
• Density (d 20/20):
  1.159 - 1.164
• As (Arsenic):
  ≤1.5 ppm
• Acetic Acid (GC):
  ≤0.1%
• Glycerol (GC):
  ≤0.1%
• 1-Monoacetin (GC):
  ≤0.1%
• 2-Monoacetin (GC):
  ≤0.1%
• 1,3-Diacetin (GC):
  ≤0.1%
• 1,2-Diacetin (GC):
  ≤0.1%
• Individual, Unspecified Impurity (GC):
  ≤0.1%
• Sum of all impurities (GC):
  ≤0.2%
• Acetic Acid (Acidity):
  ≤5000 ppm
• Butylacetate (HS-GC):
  ≤5000 ppm
• Other Residual Solvents (ICH Q3C):
  Excluded by Manufacturing Process
• Water (According to Karl Fischer):
  ≤0.2%