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Methyl-4-hydroxybenzoate 99.0-102.0% (by acidimetry), EMPROVE® ESSENTIAL NF, JP, Ph. Eur., BP, FCC suitable for use as excipient E218, SAFC®
Methyl-4-hydroxybenzoate 99.0-102.0% (by acidimetry), EMPROVE® ESSENTIAL NF, JP, Ph. Eur., BP, FCC suitable for use as excipient E218, SAFC®
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Methyl-4-hydroxybenzoate 99.0-102.0% (by acidimetry), EMPROVE® ESSENTIAL NF, JP, Ph. Eur., BP, FCC suitable for use as excipient E218, SAFC®
Certificates

Specifications

  • Environmentally Preferable:

Specifications

Specification Test Results

  • Assay (Acidimetric):
    99.0 - 102.0 %
  • Assay (HPLC):
    99.0 - 100.5 %
  • Identity:
    passes test
  • Appearance of solution:
    passes test
  • Acidic substances:
    passes test
  • Melting range (lower value):
    ≥ 125 °C
  • Melting range (upper value):
    ≤ 128 °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 %
  • Methanol (HS-GC):
    ≤ 3000 ppm
  • Other residual solvents (ICH Q3C):
    excluded by manufactoring process
  • Sulfated ash:
    ≤ 0.05 %
  • Loss on drying (80 °C):
    ≤ 0.5 %

Specification Test Results

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