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Citric acid monohydrate 99.5-100.5% (alkalimetric, calculated on anhydrous substance), crystals, EMPROVE® EXPERT Ph. Eur., BP, JP, USP, ACS, SAFC®
Irritant
Citric acid monohydrate 99.5-100.5% (alkalimetric, calculated on anhydrous substance), crystals, EMPROVE® EXPERT Ph. Eur., BP, JP, USP, ACS, SAFC®
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Irritant
Citric acid monohydrate 99.5-100.5% (alkalimetric, calculated on anhydrous substance), crystals, EMPROVE® EXPERT Ph. Eur., BP, JP, USP, ACS, SAFC®

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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
  • In water insoluble matter #:
    ≤ 0.005 %
  • Chlorid (Cl) #:
    ≤ 0.001 %
  • Phosphat (PO4) #:
    ≤ 0.001 %
  • Sulfate (SO₄):
    ≤ 20 ppm
  • Heavy metals (as Pb):
    ≤ 10 ppm
  • Al (Aluminium):
    ≤ 0.2 ppm
  • Fe (Iron) #:
    ≤ 3 ppm
  • Pb (Lead) #:
    ≤ 2 ppm
  • Oxalates (as C₂H₂O₄):
    ≤ 360 ppm
  • Residual solvents (ICH (Q3C)):
    excluded by manufacturing process
  • Readily carbonisable substance:
    passes test
  • Sulfated ash (600 °C):
    ≤ 0.02 %
  • Water (according to Karl Fischer):
    7.5 - 9.0 %
  • Total aerobic microbial count (TAMC):
    ≤ 100 CFU/g
  • Total combined yeasts/moulds count (TYMC):
    ≤ 10 CFU/g
  • Bile-tolerant gram-negative bacteria (absent in 1 g):
    passes test
  • Candida albicans (absent in 1 g):
    passes test
  • Escherichia coli (absent in 1 g):
    passes test
  • Pseudomonas aeruginosa (absent in 1 g):
    passes test
  • Salmonella (absent in 10 g):
    passes test
  • Staphylococcus aureus (absent in 1 g):
    passes test
  • Bacterial endotoxins:
    < 10

Specification Test Results

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