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Citric acid monohydrate 99.5-100.5% (alkalimetric, calculated on anhydrous substance), crystals, EMPROVE® ESSENTIAL USP, JP, E330, Ph. Eur., BP, FCC suitable for use as excipient, SAFC®
Citric acid monohydrate 99.5-100.5% (alkalimetric, calculated on anhydrous substance), crystals, EMPROVE® ESSENTIAL USP, JP, E330, Ph. Eur., BP, FCC suitable for use as excipient, SAFC®
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Citric acid monohydrate 99.5-100.5% (alkalimetric, calculated on anhydrous substance), crystals, EMPROVE® ESSENTIAL USP, JP, E330, Ph. Eur., BP, FCC suitable for use as excipient, SAFC®
Certificates

Specifications

  • Environmentally Preferable:

Specifications

Specification Test Results

  • Assay (alkalimetric, calculated on anhydrous substance):
    99.5 - 100.5 %
  • Identity (IR-spectrum):
    passes test
  • Appearance:
    white to almost white or colorless crystals
  • Appearance of solution (200 g/l; water):
    clear (≤ 3 NTU) and not more intense in color than reference solution Y₇, BY₇ or GY₇
  • Sulfate (SO₄):
    ≤ 50 ppm
  • Heavy metals (as Pb):
    ≤ 5 ppm
  • Al (Aluminium):
    ≤ 0.2 ppm
  • As (Arsenic):
    ≤ 1 ppm
  • Hg (Mercury):
    ≤ 1 ppm
  • Pb (Lead):
    ≤ 0.5 ppm
  • Oxalates (as C₂H₂O₄):
    ≤ 100 ppm
  • Residual solvents (ICH (Q3C)):
    excluded by manufacturing process
  • Readily carbonisable substance:
    passes test
  • Sulfated ash (600 °C):
    ≤ 0.05 %
  • Water (according to Karl Fischer):
    7.5 - 8.8 %
  • Bacterial endotoxins:
    < 0.5

Specification Test Results

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