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, anhydrous ≥98.0%, EMPROVE® ESSENTIAL E340, BP, Ph. Eur. suitable for use as excipient, SAFC®
 
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, anhydrous ≥98.0%, EMPROVE® ESSENTIAL E340, BP, Ph. Eur. suitable for use as excipient, SAFC®
 

 

  • Environmentally Preferable:

 

 

  • Assay (alkalimetric, calculated on dried substance):
    98.0 - 101.0 %
  • Assay (out of dried substance):
    ≥ 98.0 %
  • Identity:
    passes test
  • Appearance of solution:
    passes test
  • In water insoluble matter:
    ≤ 0.2 %
  • pH-value (1 %, water):
    8.7 - 9.4
  • Chloride (Cl):
    ≤ 0.02 %
  • Fluoride (F):
    ≤ 0.0010 %
  • Sulfate (SO₄):
    ≤ 0.1 %
  • Heavy metals (as Pb):
    ≤ 0.0010 %
  • Al (Aluminium):
    ≤ 0.0005 %
  • As (Arsenic):
    ≤ 0.0001 %
  • Cd (Cadmium):
    ≤ 0.0001 %
  • Fe (Iron):
    ≤ 0.0010 %
  • Hg (Mercury):
    ≤ 0.0001 %
  • Na (Sodium):
    ≤ 1.5 %
  • Pb (Lead):
    ≤ 0.0001 %
  • Potassium dihydrogen phosphate:
    ≤ 2.5 %
  • Residual solvents (ICH Q3C):
    excluded by manufacturing process
  • Reducing substances:
    passes test
  • Loss on drying (130 °C):
    ≤ 2.0 %

 

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