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Polysorbate 80 NF, Multi-Compendial, J.T.Baker®

Polysorbate 80 NF, Multi-Compendial, J.T.Baker®
MOC:  Regulated
Certificates
Polysorbate 80 NF, Multi-Compendial, J.T.Baker®
MOC:  Regulated

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Product Details & Documents

Vegetable based.

  • GMP manufactured product
  • Vegetable based

Suitable for use in the manufacture of parenteral dosage forms.

Synonyms:  Sorbitan monooleate, ethoxylated, Polyoxyethylene-80-Sorbitan Monolaurate, Polyoxyethylene (20) sorbitan monooleate
  • CAS Number:9005-65-6
  • MDL Number:MFCD00082107
  • Melting Pt:100 °C
  • Density:1.062 g/cm³
  •  :Management of Change (MOC) category = R
  • Melting Pt:–21 °C
  • Flash Pt:113 °C (closed cup)
  • Storage Temperature:Température ambiante
  • EINECS:500-019-9
Specifications for Product Family

Specification Test Results

  • NF - Acid Value:
    ≤2.0
  • NF - Hydroxyl Value:
    65 - 80
  • NF - Identification A:
    Passes Test
  • NF - Identification B:
    Passes Test
  • NF - Residue on Ignition:
    ≤0.25%
  • NF - Saponification Value:
    45 - 55
  • NF - Specific Gravity at 25 °C:
    1.06 - 1.09
  • NF - Viscosity at 25 °C, cSt:
    300 - 500
  • NF - Water (H₂O):
    ≤3.0%
  • NF - Peroxide Value:
    ≤10.0
  • NF - Ethylene Oxide:
    ≤1 ppm
  • NF - Dioxane:
    ≤10 ppm
  • NF - Composition of Fatty Acids - Myristic Acid:
    ≤5.0%
  • NF - Composition of Fatty Acids - Palmitic Acid:
    ≤16.0%
  • NF - Composition of Fatty Acids - Palmitoleic Acid:
    ≤8.0%
  • NF - Composition of Fatty Acids - Stearic Acid:
    ≤6.0%
  • NF - Composition of Fatty Acids - Oleic Acid:
    ≥58.0%
  • NF - Composition of Fatty Acids - Linoleic Acid:
    ≤18.0%
  • NF - Composition of Fatty Acids - Linolenic Acid:
    ≤4.0%
  • EP - Acid Value:
    ≤2.0
  • EP - Total Ash:
    ≤0.25%
  • EP - Hydroxyl Value:
    65 - 80
  • EP - Identification A:
    Passes Test
  • EP - Identification D:
    Passes Test
  • EP - Peroxide Value:
    ≤10.0
  • EP - Ethylene Oxide:
    ≤1 ppm
  • EP - Dioxan:
    ≤10 ppm
  • EP - Saponification Value:
    45 - 55
  • EP - Water (H₂O):
    ≤3.0%
  • EP/BP - Composition of Fatty Acids - Myristic Acid:
    ≤5.0%
  • EP/BP - Composition of Fatty Acids - Palmitic Acid:
    ≤16.0%
  • EP/BP - Composition of Fatty Acids - Palmitoleic Acid:
    ≤8.0%
  • EP/BP - Composition of Fatty Acids - Stearic Acid:
    ≤6.0%
  • EP/BP - Composition of Fatty Acids - Oleic Acid:
    ≥58.0%
  • EP/BP - Composition of Fatty Acids - Linoleic Acid:
    ≤18.0%
  • EP/BP - Composition of Fatty Acids - Linolenic Acid:
    ≤4.0%
  • JP - Acid Value:
    ≤2.0
  • JP - Composition of Fatty Acids - Myristic Acid:
    ≤5.0%
  • JP - Composition of Fatty Acids - Palmitic Acid:
    ≤16.0%
  • JP - Composition of Fatty Acids - Palmitoleic Acid:
    ≤8.0%
  • JP - Composition of Fatty Acids - Stearic Acid:
    ≤6.0%
  • JP - Composition of Fatty Acids - Oleic Acid:
    ≥58.0%
  • JP - Composition of Fatty Acids - Linoleic Acid:
    ≤18.0%
  • JP - Composition of Fatty Acids - Linolenic Acid:
    ≤4.0%
  • JP - Dioxane:
    ≤10 ppm
  • JP - Ethylene Oxide:
    ≤1 ppm
  • JP - Heavy Metals (as Pb):
    ≤20 ppm
  • JP - Hydroxyl Value, meq KOH/g:
    65 - 80
  • JP - Identification:
    Passes Test
  • JP - Peroxide Value:
    ≤10.0
  • JP - Residue on Ignition:
    ≤0.25%
  • JP - Water (H₂O):
    ≤3.0%
  • JP - Saponification Value:
    45 - 55
  • Additional Tests - Color (Gardner):
    ≤7
  • Additional Tests - Odor (Faint):
    Passes Test
  • Additional Tests - Water (H₂O):
    ≤0.2%
  • Additional Tests - Peroxide Value, meqO₂/kg:
    ≤2.0
  • Additional Tests - Endotoxin Concentration (EU/ml):
    ≤10
  • Free Ethylene Oxide:
    ≤1 ppm
  • 1,4-Dioxane:
    ≤5 ppm
  • 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
  • Ethylene glycol:
    ≤ 0.10 %
  • Diethylene glycol :
    ≤ 0.10 %
Product Family Options

Product Information

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