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Ethanol ≥96% (v/v), EMPROVE® EXPERT Ph. Eur., JP, USP suitable for use as excipient, SAFC®
 :  MilliporeSigma
    
 
Ethanol ≥96% (v/v), EMPROVE® EXPERT Ph. Eur., JP, USP suitable for use as excipient, SAFC®
 :  MilliporeSigma
    
 

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  • Environmentally Preferable:
    Safer Human and Environmental Health
  • Environmental Certification:
    EPA Safer chemical solvent (green circle rating); Chem21 solvent selection guide recommended by default and after discussion

 

 

  • Assay (d20°C/4°C) (m/m):
    92.6 - 95.2 %
  • Assay (d20°C/4°C) (V/V):
    95.1 - 96.9 %
  • Assay (d 15°C/15°C) (V/V):
    95.1 - 96.9 %
  • Assay (d15.56°C/15.56°C) (m/m):
    92.3 - 93.8 %
  • Assay (d15.56°C/15.56°C) (V/V):
    94.9 - 96.0 %
  • Identity (IR):
    conforms
  • Appearance:
    conforms
  • Clarity of solution:
    conforms
  • Color of solution:
    conforms
  • Acidity or alkalinity:
    ≤ 30 ppm
  • Density (d 20 °C/20 °C):
    0.805 - 0.812
  • Density (d 15 °C/15 °C):
    0.809 - 0.816
  • Density (d 15,56 °C/15,56 °C):
    0.812 - 0.816
  • Specific gravity (d 15 °C/15 °C):
    0.80872 - 0.81601
  • Absorbance (at 240 nm):
    ≤ 0.40
  • Absorbance (between 250nm and 260nm):
    ≤ 0.30
  • Absorbance (between 270nm and 340nm):
    ≤ 0.10
  • The spectrum shows a steadily descending curve with no observable peaks or shoulders:
    conforms
  • Volatile impurities (Acetaldehyde and Acetal):
    ≤ 10 ppm
  • Volatile impurities (Benzene):
    ≤ 2 ppm
  • Volatile impurities (Methanol):
    ≤ 200 ppm
  • Volatile impurities (Total of other impurities):
    ≤ 300 ppm
  • Volatile impurities (disregard limit):
    ≤ 9 ppm
  • Residual solvents (ICH Q3C):
    excluded by the manufacturing process
  • Evaporation residue:
    ≤ 25 mg/l