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Propyl-4-hydroxybenzoate 99.0-100.5% (by HPLC), EMPROVE® ESSENTIAL FCC, BP, Ph. Eur., JP, NF suitable for use as excipient E216, SAFC®
 
Propyl-4-hydroxybenzoate 99.0-100.5% (by HPLC), EMPROVE® ESSENTIAL FCC, BP, Ph. Eur., JP, NF suitable for use as excipient E216, SAFC®
 

 

  • Environmentally Preferable:

 

 

  • Assay (by Acidimetry following Saponification):
    98.0 - 102.0%
  • Assay (HPLC):
    99.0 - 100.5%
  • Identity:
    Passes Test
  • Appearance of Solution:
    Passes Test
  • Acidic Substances:
    Passes Test
  • Melting range (Lower Value):
    ≥96 °C
  • Melting range (Upper Value):
    ≤98 °C
  • Heavy metals (as Pb):
    ≤10 ppm
  • As (Arsenic):
    ≤3 ppm
  • Cd (Cadmium):
    ≤10 ppm
  • Cu (Copper):
    ≤10 ppm
  • Hg (Mercury):
    ≤1 ppm
  • Pb (Lead):
    ≤2 ppm
  • Zn (Zinc):
    ≤10 ppm
  • Related Substances (HPLC):
    Passes Test
  • p-Hydroxy Benzoic Acid:
    ≤0.5%
  • Sum of all Impurities:
    ≤1.0%
  • Largest Unspecified Impurity:
    ≤0.5%
  • 1-Propylalcohol (HS-GC):
    ≤5000 ppm
  • Other Residual Solvents (ICH Q3C):
    Excluded by Manufactoring Process
  • Sulfated Ash:
    ≤0.05%
  • Loss on Drying (80 °C):
    ≤0.5%

 

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