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Potassium dihydrogen phosphate, crystallised, EMPROVE® EXPERT Ph. Eur., BP, JPC, NF for biopharmaceutical production, SAFC®
 
Potassium dihydrogen phosphate, crystallised, EMPROVE® EXPERT Ph. Eur., BP, JPC, NF for biopharmaceutical production, SAFC®
 

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  • Assay (alkalimetric, calculated on dried substance):
    98.0 - 100.5 %
  • Assay (alkalimetric; dried substance):
    ≥ 99.0 %
  • Identity:
    passes test
  • Appearance of solution:
    passes test
  • Insoluble substances:
    ≤ 0.2 %
  • pH-value (2 %; water):
    4.2 - 4.6
  • pH-value (5 %; water):
    4.2 - 4.5
  • Carbonate:
    passes test
  • Condensed phosphate:
    passes test
  • Chloride (Cl):
    ≤ 0.009 %
  • Fluoride (F):
    ≤ 0.0010 %
  • Sulfate (SO₄):
    ≤ 0.017 %
  • Heavy metals (as Pb):
    ≤ 0.0010 %
  • Al (Aluminium):
    ≤ 0.0005 %
  • As (Arsenic):
    ≤ 0.0002 %
  • Fe (Iron):
    ≤ 0.0010 %
  • Na (Sodium):
    ≤ 0.1 %
  • 0:
    passes test
  • Pb (Lead):
    ≤ 0.0004 %
  • Endotoxins:
    ≤ 2.5 I.U./g
  • Total aerobic microbial count:
    ≤ 100 CFU/g
  • Total yeast and mould count:
    ≤ 100 CFU/g
  • DNases (Exo- and endonucleases) (not detectable):
    passes test
  • RNases (not detectable):
    passes test
  • Proteases (not detectable):
    passes test
  • Residual solvents (ICH Q3C):
    excluded by manufacturing process
  • Reducing substances:
    passes test
  • Loss on drying (105 °C):
    ≤ 0.5 %
  • Loss on drying (130 °C):
    ≤ 1.0 %

 

 

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