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Glutathione (reduced) 98.0-101.0% (by iodometry), EMPROVE® EXPERT Ph. Eur. for biopharmaceutical production, SAFC®
 
Glutathione (reduced) 98.0-101.0% (by iodometry), EMPROVE® EXPERT Ph. Eur. for biopharmaceutical production, SAFC®
 

 

  • Environmentally Preferable:

 

 

  • Assay (iodometric, calc. on dried substance):
    98.0 - 101.0 %
  • Identity (IR-spectrum):
    passes test
  • Appearance:
    white to almost white, slightly agglomerated, crystalline powder
  • Appearance of solution (100 g/l, water):
    clear and colorless.
  • Spec. rotation (α 20/D, 40 g/l, water, calc. on dried substance):
    -15.5° to -17.5°
  • Chloride (Cl):
    ≤ 200 ppm
  • Sulfate (SO₄):
    ≤ 300 ppm
  • As (Arsenic):
    ≤ 1.5 ppm
  • Fe (Iron):
    ≤ 10 ppm
  • Fe (Iron) (ICP):
    ≤ 10 ppm
  • NH₄ (Ammonium):
    ≤ 200 ppm
  • Cu (Copper)*:
    ≤ 25 ppm
  • Related substances (CE) (Impurity A (Cysteinylglycine)):
    ≤ 0.5 %
  • Related substances (CE) (Impurity B (Cysteine)):
    ≤ 0.5 %
  • Related substances (CE) (Impurity C (Glutathione oxidized)):
    ≤ 1.5 %
  • Related substances (CE) (Impurity D (Glutamylcysteine)):
    ≤ 1.0 %
  • Related substances (CE) (Impurity E):
    ≤ 0.5 %
  • Related substances (CE) (Largest unspecified impurity):
    ≤ 0.2 %
  • Related substances (CE) (Sum of all impurities):
    ≤ 2.5 %
  • Acetic acid (HS-GC):
    ≤ 5000 ppm
  • Ethanol (HS-GC):
    ≤ 5000 ppm
  • Ethyl acetate (HS-GC):
    ≤ 5000 ppm
  • Other residual solvents (ICH Q3C):
    passes test
  • Sulfated ash (600 °C):
    ≤ 0.1 %
  • Loss on drying (105 °C; 3 h):
    ≤ 0.5 %
  • Corresponds to Ph. Eur.:

 

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