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di-Sodium hydrogen phosphate heptahydrate, EMPROVE® ESSENTIAL USP, DAC suitable for use as excipient, SAFC®

Specifications

  • Environmentally Preferable:

Specifications

Specification Test Results

  • Assay (alkalimetric, calculated on dried substance):
    98.0 - 100.5 %
  • Identity:
    passes test
  • Appearance of solution:
    passes test
  • Insoluble substances:
    ≤ 0.4 %
  • pH-value (5 %; water):
    8.7 - 9.3
  • Sodium Dihydrogene phospate (NaH₂PO₄):
    passes test
  • Chloride (Cl):
    ≤ 0.0200 %
  • Sulfate (SO₄):
    ≤ 0.0500 %
  • Heavy metals (as Pb):
    ≤ 0.0010 %
  • As (Arsenic):
    ≤ 0.0002 %
  • Fe (Iron):
    ≤ 0.0020 %
  • Residual solvents (ICH Q3C):
    excluded by manufacturing process
  • Reducing substances:
    passes test
  • Loss on drying (130 °C):
    45.0 - 49.0 %

Specification Test Results

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