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Sodium chloride 99.5-100.5% (by argentometric analysis, on dry substance), EMPROVE® EXPERT BP, Ph. Eur., USP, JP, SAFC®
 
Sodium chloride 99.5-100.5% (by argentometric analysis, on dry substance), EMPROVE® EXPERT BP, Ph. Eur., USP, JP, SAFC®
 

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  • Assay (argentometric; calculated on dried substance):
    99.5 - 100.5 %
  • Identity:
    passes test
  • Appearance of solution:
    passes test
  • Acidity or alkalinity:
    passes test
  • Bromide (Br):
    ≤ 0.005 %
  • Ferrocyanides:
    passes test
  • Iodide (I):
    passes test
  • Nitrite (NO₂) (UV-absorption 354nm; 1cm; 10%; water):
    ≤ 0.01
  • Phosphate (PO₄):
    ≤ 0.0025 %
  • Sulfate (SO₄):
    ≤ 0.0200 %
  • Heavy metals (as Pb):
    ≤ 0.0003 %
  • Al (Aluminium):
    ≤ 0.00002 %
  • As (Arsenic):
    ≤ 0.0001 %
  • Ba (Barium):
    passes test
  • Ca (Calcium):
    ≤ 0.002 %
  • Fe (Iron):
    ≤ 0.0002 %
  • K (Potassium):
    ≤ 0.01 %
  • Magnesium and alkaline-earth metals (as Ca):
    ≤ 0.0100 %
  • Residual solvents (ICH Q3C):
    excluded by production process
  • Loss on drying (105 °C, 2 h):
    ≤ 0.5 %
  • Endotoxins (kinetic turbidimetric test):
    ≤ 2.5 I.U./g
  • Microbiological purity (Total aerobic microbial count (TAMC)):
    ≤ 100.0 CFU/g
  • Microbiological purity (Total yeast and mould count (TYMC)):
    ≤ 100.0 CFU/g
  • DNases (Exo- and endonucleases) (not detectable):
    passes test
  • RNases (not detectable):
    passes test
  • Proteases (not detectable):
    passes test
  • Nicking Activity (not detectable):
    passes test

 

 

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