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Ethanol absolute, EMPROVE® EXPERT Ph. Eur., BP, ChP, JP, USP suitable for use as excipient, SAFC®
 
Ethanol absolute, EMPROVE® EXPERT Ph. Eur., BP, ChP, JP, USP suitable for use as excipient, SAFC®
 

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  • Assay (m/m):
    ≥ 99.2 %
  • Assay (V/V):
    ≥ 99.5 %
  • Identity (IR):
    conforms
  • Identity 1 (ChP):
    conforms
  • Appearance:
    conforms
  • Clarity of solution:
    conforms
  • Color of solution:
    conforms
  • Clarity and color of solution (ChP):
    conforms
  • Acidity or alkalinity:
    ≤ 30 ppm
  • Acidity or alkalinity (ChP):
    conforms
  • Density (d 20 °C/20 °C):
    0.790 - 0.793
  • Density (d 15,56 °C/15,56 °C):
    ≤ 0.7962
  • Density (d 15 °C/15 °C):
    0.794 - 0.797
  • Specific gravity (d 15 °C/15 °C):
    0.79422 - 0.79679
  • Absorbance (at 240 nm):
    ≤ 0.40
  • Absorbance (between 250 nm and 260 nm):
    ≤ 0.30
  • Absorbance (between 270 nm and 340 nm):
    ≤ 0.10
  • The spectrum shows a steadily descending curve with no observable peaks or shoulders:
    conforms
  • Absorbance (ChP) (at 240 nm):
    ≤ 0.08
  • Absorbance (ChP) (between 250 nm and 260 nm):
    ≤ 0.06
  • Absorbance (ChP) (between 270 nm and 340 nm):
    ≤ 0.02
  • Volatile impurities (GC) (Acetaldehyde and Acetal):
    ≤ 10 ppm
  • Volatile impurities (GC) (Benzene):
    ≤ 2 ppm
  • Volatile impurities (GC) (Methanol):
    ≤ 100 ppm
  • Volatile impurities (GC) (Total of other impurities):
    ≤ 300 ppm
  • Cyclohexane (GC):
    ≤ 50 ppm
  • Evaporation residue:
    ≤ 25 mg/l
  • Non-volatile matter:
    ≤ 25 mg/l
  • Bacterial endotoxins:
    ≤ 2.5 I.U./ml

 

 

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