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Sodium carbonate, anhydrous 99.5-100.5% (by acidimetry), EMPROVE® EXPERT Ph. Eur., BP, JP, NF for biopharmaceutical production, SAFC®
 
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Sodium carbonate, anhydrous 99.5-100.5% (by acidimetry), EMPROVE® EXPERT Ph. Eur., BP, JP, NF for biopharmaceutical production, SAFC®
 

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  • Assay (Acidimetric; Calculated on Dried Substance):
    99.5 - 100.5 %
  • Appearance of Solution:
    Passes Test
  • Identity:
    Passes Test
  • Chloride (Cl):
    ≤0.0125%
  • Sulfate (SO₄):
    ≤0.025%
  • Heavy metals (as Pb):
    ≤0.001%
  • As (Arsenic):
    ≤0.00031%
  • Fe (Iron):
    ≤0.0050%
  • Alkali Hydroxides and Alkali Hydrogen Carbonates:
    Passes Test
  • Residual Solvents (Ph. Eur./USP/ICH):
    Excluded by Manufacturing Process
  • Loss on Drying (300 °C):
    ≤0.5%
  • Endotoxins:
    ≤2.5 I.U./g
  • Total Aerobic Microbial Count:
    ≤100 CFU/g
  • Total Yeast and Mould Count:
    ≤100 CFU/g

 

 

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