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TRITON™ X-100 (Polyethylenglycol-tert-octylphenylether), EMPROVE® EXPERT Ph. Eur. für die biopharmazeutische Produktion, SAFC®
 
TRITON™ X-100 (Polyethylenglycol-tert-octylphenylether), EMPROVE® EXPERT Ph. Eur. für die biopharmazeutische Produktion, SAFC®
 

 

  • Environmentally Preferable:

 

 

  • Assay (HPLC):
    90.0 - 110.0 %
  • Identity (IR-spectrum):
    passes test
  • Identity (Cloud point):
    passes test
  • Appearance:
    Almost clear, almost colorless to sligthly yellowish liquid (≤ 100 Hazen).
  • Density (d 20/4):
    1.064 - 1.067
  • Acidity or alkalinity:
    passes test
  • pH-value (10 g/l in KCl(1g/l)):
    6.0 - 8.0
  • Cloud point:
    63 - 69 °C
  • Chloride (Cl):
    ≤ 50 ppm
  • Phosphate (PO₄):
    ≤ 1000 ppm
  • Sulfate (SO₄):
    ≤ 50 ppm
  • Heavy metals (as Pb):
    ≤ 10 ppm
  • K (Potassium):
    ≤ 1000 ppm
  • Na (Sodium):
    ≤ 1000 ppm
  • Acetaldehyde (GC):
    ≤ 5 ppm
  • Dioxane (GC):
    ≤ 10 ppm
  • Ethylenglycol (GC):
    ≤ 620 ppm
  • Ethylene oxide (GC):
    ≤ 1 ppm
  • Formaldehyde:
    ≤ 5 ppm
  • Average number of oxyethylene moieties (H-NMR):
    43747
  • Other residual solvents (ICH Q3C):
    passes test
  • Hydroxyl value:
    85 - 101
  • Ash (600 °C):
    ≤ 0.2
  • Sulfated ash (600 °C):
    ≤ 0.4
  • Water (according to Karl Fischer):
    ≤ 0.2
  • Bacterial endotoxins:
    ≤ 100 I.U./ml
  • TAMC (Total aerobic microbial count):
    ≤ 10²
  • TYMC (Total yeast and mould count):
    ≤ 10²

 

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