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Disodium hydrogen phosphate, anhydrous 98.0-100.5% (by acidometric titration), EMPROVE® ESSENTIAL JPE, BP, E339, Ph. Eur., USP suitable for use as excipient, SAFC®
Disodium hydrogen phosphate, anhydrous 98.0-100.5% (by acidometric titration), EMPROVE® ESSENTIAL JPE, BP, E339, Ph. Eur., USP suitable for use as excipient, SAFC®
Certificates
Disodium hydrogen phosphate, anhydrous 98.0-100.5% (by acidometric titration), EMPROVE® ESSENTIAL JPE, BP, E339, Ph. Eur., USP suitable for use as excipient, SAFC®
Certificates

Specifications

  • Environmentally Preferable:

Specifications

Specification Test Results

  • Assay (calculated on dried substance according to Ph Eur):
    98.0 - 101.0 %
  • Assay (calculated on dried substance according to USP):
    98.0 - 100.5 %
  • Assay (acidimetric; dried substance):
    99.0 - 101.0 %
  • Identity:
    passes test
  • Appearance of solution:
    passes test
  • In water insoluble matter (calculated on dried substance):
    ≤ 0.20 %
  • Sodium dihydrogen phosphate (NaH₂PO₄):
    ≤ 1.7 %
  • pH-value (1 %, water):
    9.0 - 9.4
  • Carbonate:
    passes test
  • Chloride (Cl):
    ≤ 0.01 %
  • Fluoride (F):
    ≤ 0.001 %
  • Sulfate (SO₄):
    ≤ 0.03 %
  • Heavy metals (as Pb):
    ≤ 0.001 %
  • As (Arsenic):
    ≤ 0.0001 %
  • Cd (Cadmium):
    ≤ 0.0001 %
  • Fe (Iron):
    ≤ 0.002 %
  • Hg (Mercury):
    ≤ 0.0001 %
  • Ni (Nickel)*:
    ≤ 0.0002
  • Pb (Lead):
    ≤ 0.0001 %
  • Residual solvents (ICH Q3C):
    excluded by production process
  • Substances reducing potassium permanganate:
    passes test
  • Loss on drying (130 °C):
    ≤ 1.0 %
  • Particle size (< 0.315 mm):
    about 99 %

Specification Test Results

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