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

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

Glass bottle, amber, narrow mouth, 20 ml
Catalog # JT4117-2
Supplier #:  4117-02
Polysorbate 80 NF, Multi-Compendial, J.T.Baker®
Catalog # JT4117-2
CAS Number:  9005-65-6
Polysorbate 80 NF, Multi-Compendial, J.T.Baker®
Polysorbate 80 NF, Multi-Compendial, J.T.Baker®

Glass bottle, amber, narrow mouth, 20 ml

CAS Number:  9005-65-6
MOC:  Regulado
Price
$4,119.25
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Each (20ml)
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Product Details & Documents

Vegetable based.

  • GMP manufactured product
  • Vegetable based

Suitable for use in the manufacture of parenteral dosage forms.

Sinónimos:  Sorbitan monooleate, ethoxylated, Polyoxyethylene-80-Sorbitan Monolaurate, Polyoxyethylene (20) sorbitan monooleate
  • CAS Number:9005-65-6
  • Número MDL:MFCD00082107
  • Punto de fusión:100 °C
  • Densidad:1.062 g/cm³
  •  :Management of Change (MOC) category = R
  • Punto de fusión:–21 °C
  • Punto de inflamación:113 °C (closed cup)
  • Temperatura de almacenamiento:Ambient
  • EINECS:500-019-9
Especificaciones

Resultados de prueba de especificación

  • 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 %
  • Appearance:
    Passes Test
  • 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 - 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 %

Especificaciones

  • Pack type:
    Glass bottle, amber, narrow mouth
  • Size:
    20 ml
  • Cat. No.:
    JT4117-2

Especificaciones

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