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Polyethylene glycol 400, EMPROVE® ESSENTIAL JP, Ph. Eur. suitable for use as excipient, SAFC®
 
Polyethylene glycol 400, EMPROVE® ESSENTIAL JP, Ph. Eur. suitable for use as excipient, SAFC®
 

 

  • Environmentally Preferable:

 

 

  • Identity (according to JP):
    passes test
  • Identity (according to Ph. Eur.):
    passes test
  • Appearance:
    clear, viscous, colourless hygroscopic liquid
  • Appearance of solution:
    passes test
  • Acidity,Alkalinity:
    passes test
  • Reducing substances:
    passes test
  • pH-value (5 %; water, 25 °C):
    4.0 - 7.0
  • Density (d 20/20):
    1.110 - 1.140
  • Viscosity (20 °C):
    100 - 111 mm²/s
  • Viskosity (20 °C):
    112 - 124 mPa∙s
  • Heavy metals:
    ≤ 20 ppm
  • Formaldehyde:
    ≤ 30 ppm
  • Ethylene glycol and diethylene glycol:
    ≤ 0.25 %
  • Ethylene glycol (acc. to ICH-guideline class 2):
    ≤ 620 ppm
  • Ethylene oxide (GC):
    ≤ 1 ppm
  • Dioxane (GC):
    ≤ 10 ppm
  • Hydroxyl value:
    264 - 300
  • Average molecular mass:
    380 - 420
  • Sulfated ash:
    ≤ 0.1 %
  • Water (K. F.):
    ≤ 1.0 %

 

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