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di-Sodium hydrogénophosphate dihydraté, EMPROVE® EXPERT USP, BP, Ph. Eur. for biopharmaceutical production, SAFC®
 
di-Sodium hydrogénophosphate dihydraté, EMPROVE® EXPERT USP, BP, Ph. Eur. for biopharmaceutical production, SAFC®
 

 

  • Environmentally Preferable:

 

 

  • Assay (calculated on dried substance according to Ph Eur):
    98.0 - 101.0 %
  • Assay (calculated on dried substance according to USP):
    98.0 - 100.5 %
  • Identity:
    passes test
  • Appearance of solution:
    passes test
  • In water insoluble matter:
    ≤ 0.3 %
  • pH-value (5 %; water):
    8.9 - 9.2
  • Chloride (Cl):
    ≤ 0.005 %
  • Sulfate (SO₄):
    ≤ 0.02 %
  • Heavy metals (as Pb):
    ≤ 0.001 %
  • As (Arsenic):
    ≤ 0.0002 %
  • Fe (Iron):
    ≤ 0.001 %
  • Sodium dihydrogen phosphate (NaH₂PO₄):
    ≤ 1.7 %
  • Residual solvents (ICH Q3C):
    excluded by manufacturing process
  • Substances reducing potassium permanganate (as O):
    passes test
  • Loss on drying (130 °C):
    19.5 - 21.0 %
  • Endotoxins:
    ≤ 2.5 I.U./g
  • Total aerobic microbial count:
    ≤ 1E+02 CFU/g
  • Total yeast and mould count:
    ≤ 1E+02 CFU/g
  • DNases (Exo- and endonucleases) (not detectable):
    passes test
  • RNases (not detectable):
    passes test
  • Proteases (not detectable):
    passes test

 

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