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Sodium carbonate monohydraté 99.5-100.5% (base substance sèche), EMPROVE® ESSENTIAL E500, NF, Ph. Eur., BP suitable for use as excipient, SAFC®
Sodium carbonate monohydraté 99.5-100.5% (base substance sèche), EMPROVE® ESSENTIAL E500, NF, Ph. Eur., BP suitable for use as excipient, SAFC®
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Sodium carbonate monohydraté 99.5-100.5% (base substance sèche), EMPROVE® ESSENTIAL E500, NF, Ph. Eur., BP suitable for use as excipient, SAFC®

Spécifications

  • Environmentally Preferable:

Spécifications

Résultats des tests de spécification

  • Assay (Na₂CO₃):
    83.0 - 87.5 %
  • Assay (acidimetric; calculated on dried substance):
    99.5 - 100.5 %
  • Identity:
    passes test
  • Appearance of solution:
    passes test
  • Alkali hydroxides and Alkali hydrogen carbonates:
    passes test
  • Chloride (Cl):
    ≤ 0.0125 %
  • Sulfate (SO₄):
    ≤ 0.0250 %
  • Heavy metals (as Pb):
    ≤ 0.0010 %
  • As (Arsenic):
    ≤ 0.0003 %
  • Cu (Copper):
    ≤ 0.0025 %
  • Fe (Iron):
    ≤ 0.0050 %
  • Hg (Mercury):
    ≤ 0.0001 %
  • Pb (Lead):
    ≤ 0.0002 %
  • Zn (Zinc):
    ≤ 0.0025 %
  • Residual solvents (ICH Q3C):
    excluded by manufacturing process
  • Loss on drying (300 °C):
    12.0 - 15.0 %

Résultats des tests de spécification

Informations associées

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