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Polysorbate 20 NF, Multi-Compendial, J.T.Baker®
Polysorbate 20 NF, Multi-Compendial, J.T.Baker®
Supplier:  Avantor
Certificates
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Polysorbate 20 NF, Multi-Compendial, J.T.Baker®
Supplier:  Avantor
Certificates

Specifications

  • Environmentally Preferable:

Specifications

Specification Test Results

  • Ethylene glycol:
    ≤ 0.10 %
  • Diethylene glycol :
    ≤ 0.10 %
  • GMP Manufactured Product:
    ≤2.0
  • Meets JPE Specifications:
    ≤0.25%
  • Meets N.F. Requirements:
    ≤10 ppm
  • Meets E.P. Chemical Specifications:
    ≤1 ppm
  • Meets B.P. Chemical Specifications:
    96 - 108
  • Store in airtight container, protected from light:
    Passes Test
  • CAUTION: For Manufacturing, processing or repackaging:
    Passes Test
  • Bulk Pharmaceutical Chemical:
    40 - 50
  • NF - Acid Value:
    ≤ 2.0
  • NF - Residue on Ignition:
    ≤ 0.25 %
  • NF - Dioxane:
    ≤ 10 ppm
  • NF - Ethylene Oxide:
    ≤ 1 ppm
  • NF - Hydroxyl Value, mg KOH/g:
    96 - 108
  • NF - Identification A:
    Passes Test
  • NF - Identification B:
    Passes Test
  • NF - Saponification Value, mg KOH/g:
    40 - 50
  • NF - Caproic Acid (Composition of Fatty Acids):
    ≤ 1.0 %
  • NF - Caprylic Acid (Composition of Fatty Acids):
    ≤ 10.0 %
  • NF - Capric Acid (Composition of Fatty Acids):
    ≤ 10.0 %
  • NF - Lauric Acid (Composition of Fatty Acids):
    40.0 - 60.0 %
  • NF - Myristic Acid (Composition of Fatty Acids):
    14.0 - 25.0 %
  • NF - Palmitic Acid (Composition of Fatty Acids):
    7.0 - 15.0 %
  • NF - Stearic Acid (Composition of Fatty Acids):
    ≤ 11.0 %
  • NF - Oleic Acid (Composition of Fatty Acids):
    ≤ 11.0 %
  • NF - Linoleic Acid (Composition of Fatty Acids):
    ≤ 3.0 %
  • NF - Peroxide Value:
    ≤ 5.0
  • NF - Water (H₂O):
    ≤ 3.0 %
  • Endotoxin Concentration (EU/mL):
    ≤ 10
  • EP/BP - Acid Value:
    ≤ 2.0
  • EP/BP - Total Ash:
    ≤ 0.25 %
  • EP/BP - Composition of Fatty Acids - Caproic Acid:
    ≤ 1.0 %
  • EP/BP - Composition of Fatty Acids - Caprylic Acid:
    ≤ 10.0 %
  • EP/BP - Composition of Fatty Acids - Capric Acid:
    ≤ 10.0 %
  • EP/BP - Composition of Fatty Acids - Lauric Acid:
    40.0 - 60.0 %
  • EP/BP - Composition of Fatty Acids - Myristic Acid:
    14.0 - 25.0 %
  • EP/BP -Composition of Fatty Acids - Palmitic Acid:
    7.0 - 15.0 %
  • EP/BP - Composition of Fatty Acids - Stearic Acid:
    ≤ 7.0 %
  • EP/BP - Composition of Fatty Acids - Oleic Acid:
    ≤ 11.0 %
  • EP/BP - Composition of Fatty Acids - Linoleic Acid:
    ≤ 3.0 %
  • EP - Identification A:
    Passes Test
  • EP - Identification D:
    Passes Test
  • EP/BP - Hydroxyl Value:
    96 - 108
  • EP - Peroxide Value:
    ≤ 10.0
  • EP - Saponification Value:
    40 - 50
  • EP - Water (H₂O):
    ≤ 3.0 %
  • EP - Ethylene Oxide:
    ≤ 1 ppm
  • EP - Dioxan:
    ≤ 10 ppm
  • Appearance:
    Passes Test
  • pH of 5% Solution at 25°C:
    5.0 - 7.0
  • Arsenic (As):
    ≤ 1.000 ppm
  • Peroxide Value, meqO₂/kg:
    ≤ 2.0
  • Microbiological - Total Aerobic Microbial Count (cfu/g):
    ≤ 100
  • Microbiological - Escherichia Coli:
    Passes Test
  • Microbiological - Pseudomonas aeruginosa:
    Passes Test
  • Microbiological - Salmonella:
    Passes Test
  • Microbiological - Staphylococcus aureus:
    Passes Test
  • Microbiological - Total Yeast and Mold Count (cfu/g):
    ≤ 50
  • JPE - Identification 1:
    Passes Test
  • JPE - Identification 2:
    Passes Test
  • JPE - Identification 3:
    Passes Test
  • JPE - Moisture Content:
    ≤ 3.0 %
  • JPE - Acid Value:
    ≤ 4.0
  • JPE - Saponification Value (mg KOH/g):
    43 - 55
  • JPE - pH:
    4.0 - 7.0
  • JPE - Residue on Ignition:
    ≤ 0.25 %
  • JPE - Specific Gravity at 20°C:
    1.090 - 1.130
  • JPE - Viscosity (mm²/S):
    350 - 550
  • JPE - Heavy Metals (as Pb):
    ≤ 20 ppm
  • JPE - Arsenic (As):
    ≤ 2 ppm

Specification Test Results

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