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Polyvinyl alcohol 4-88, EMPROVE® ESSENTIAL USP, Ph. Eur., ChP, JPE suitable for use as excipient, SAFC®
 
Polyvinyl alcohol 4-88, EMPROVE® ESSENTIAL USP, Ph. Eur., ChP, JPE suitable for use as excipient, SAFC®
 

 

  • Environmentally Preferable:

 

 

  • Identity (IR spectrum):
    passes test
  • Identity (Viscosity):
    passes test
  • Identity (Reaction with iodine):
    passes test
  • Identity (Reaction with iodine and boric acid):
    passes test
  • Identity (Reaction with ethanol):
    passes test
  • Appearance of solution (40 g/l, water):
    passes test
  • Appearance of solution (50 g/l, water):
    passes test
  • Water-insoluble matter (40 g/l, water):
    ≤ 0.1 %
  • pH-Value (40 g/l; water):
    5.0 - 6.5
  • Viscosity (40 g/l; water):
    3.4 - 4.6 mPa∙s
  • As (Arsenic):
    ≤ 2 ppm
  • Heavy metals (as Pb):
    ≤ 10 ppm
  • Crotonaldehyde (GC):
    ≤ 10 ppm
  • Acetic acid (alkalimetric):
    ≤ 0.5 %
  • Methanol (GC):
    ≤ 1.0 %
  • Methyl acetate (GC):
    ≤ 1.0 %
  • Other residual solvents (ICH Q3C):
    excluded by production process
  • Ester value:
    130 - 150
  • Degree of hydrolysis (USP):
    85 - 89 %
  • Degree of hydrolysis (JPE):
    78 - 96 %
  • Acid value:
    ≤ 3.0
  • Saponification value:
    132 - 152
  • Sulfated ash:
    ≤ 1.0 %
  • Loss on Drying (105 °C):
    ≤ 5.0 %
  • Endotoxins:
    ≤ 0.03 I.U./mg
  • Microbiological purity (Total aerobic microbial count (TAMC)):
    ≤ 100 CFU/g
  • Microbiological purity (Total yeast and mould count (TYMC)):
    ≤ 100 CFU/g
  • Bile-tolerant gram-negative bacteria (absent in 1 g):
    conforms
  • Escherichia coli (absent in 1 g):
    conforms
  • Pseudomonas aeruginosa (absent in 1 g):
    conforms
  • Staphylococcus aureus (absent in 1 g):
    conforms
  • Candida albicans (absent in 1 g):
    conforms
  • Salmonella (absent in 10 g):
    conforms

 

 

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