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tri-Natriumcitrat Dihydrat ≥99,0%, Kristalle, EMPROVE® ESSENTIAL E331, BP, Ph. Eur., JP, USP suitable for use as excipient, SAFC®
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tri-Natriumcitrat Dihydrat ≥99,0%, Kristalle, EMPROVE® ESSENTIAL E331, BP, Ph. Eur., JP, USP suitable for use as excipient, SAFC®
Zertifikate

Spezifikationen

  • Environmentally Preferable:

Spezifikationen

Spezifikation Testergebnisse

  • Assay (Perchloric acid titration, calc. on anhydrous substance (Ph Eur)):
    99.0 - 101.0 %
  • Assay (Perchloric acid titration, previously dried substance) (JP/USP):
    99.0 - 100.5 %
  • Identity (Na):
    passes test
  • Identity (Citrate):
    passes test
  • Identity (reaction upon ignition):
    passes test
  • Appearance:
    white to almost white crystals
  • Appearance of solution (100 g/l, CO₂-free water):
    clear and colorless
  • Acidity or alkalinity:
    passes test
  • pH (50 g/l CO₂-free water):
    7.5 - 8.5
  • Chloride (Cl):
    ≤ 50 ppm
  • Sulfate (SO₄):
    ≤ 150 ppm
  • Heavy metals (as Pb):
    ≤ 5 ppm
  • Al (Aluminium):
    ≤ 5 ppm
  • As (Arsenic):
    ≤ 1 ppm
  • Hg (Mercury):
    ≤ 1 ppm
  • Pb (Lead):
    ≤ 1 ppm
  • Oxalate (as C₂H₂O₄):
    ≤ 100 ppm
  • Tartrate (C₄H₄O₆):
    passes test
  • Residual solvents (ICH (Q3C)):
    excluded by manufacturing process
  • Readily carbonisable substance:
    passes test
  • Water (according to Karl Fischer):
    11.0 - 13.0 %
  • Loss on drying (180 °C, 18 h):
    10.0 - 13.0 %

Spezifikation Testergebnisse

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