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Ethanol 96% (v/v), EMPROVE® EXPERT Ph. Eur., BP, ChP, extra pure, SAFC®
    
 
Ethanol 96% (v/v), EMPROVE® EXPERT Ph. Eur., BP, ChP, extra pure, SAFC®
    
 

 

  • Environmentally Preferable:

 

 

  • Assay (m/m):
    92.6 - 95.2 %
  • Assay (V/V):
    95.1 - 96.9 %
  • Identity (IR):
    conforms
  • Identity 1 (ChP):
    conforms
  • Appearance:
    conforms
  • Clarity and color of solution (ChP):
    conforms
  • Acidity or alkalinity:
    ≤ 30 ppm
  • Acidity or alkalinity (ChP):
    conforms
  • Density (d 20 °C/20 °C):
    0.805 - 0.812
  • Density (d 20 °C/20 °C) (ChP):
    ≤ 0.8129
  • 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
  • Other residual solvents (ICH Q3C):
    excluded by production process
  • Evaporation residue:
    ≤ 25 mg/l
  • Non-volatile matter:
    ≤ 25 mg/l
  • Bacterial endotoxins:
    ≤ 2.5
  • Staphylococcus aureus (absent in 1 g):
    passes test
  • Total aerobic microbial count (TAMC):
    ≤ 100 CFU/ml
  • Total combined yeasts/moulds count (TYMC):
    ≤ 10 CFU/ml

 

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