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Polyvinyl alcohol 26 - 88, EMPROVE® EXPERT USP, Ph. Eur., JPE suitable for use as excipient, hydrolysed, SAFC®
Polyvinyl alcohol 26 - 88, EMPROVE® EXPERT USP, Ph. Eur., JPE suitable for use as excipient, hydrolysed, SAFC®
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Polyvinyl alcohol 26 - 88, EMPROVE® EXPERT USP, Ph. Eur., JPE suitable for use as excipient, hydrolysed, SAFC®

Specifications

  • Environmentally Preferable:

Specifications

Specification Test Results

  • 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
  • Water-Insoluble Matter (40 g/l, Water):
    ≤0.1%
  • pH-Value (40 g/l; Water):
    5.0 - 6.5
  • Viscosity (40 g/l; Water):
    22.1 - 29.9 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%
  • 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

Specification Test Results

Related Information

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