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

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

Glass bottle, amber, narrow mouth, 20 mL
  4117-02
  
 :   Avantor
Polysorbat 80 NF, Multi-Compendial, J.T.Baker®
  4117-02
 :  Avantor
 :  9005-65-6
Polysorbat 80 NF, Multi-Compendial, J.T.Baker®
Polysorbat 80 NF, Multi-Compendial, J.T.Baker®

Glass bottle, amber, narrow mouth, 20 mL

 
 
 
 :  9005-65-6
 
1.030,00 kr
   
1 * 20 mL
 
  • GMP manufactured product
  • Vegetable based

Suitable for use in the manufacture of parenteral dosage forms.

 :  Sorbitanmono(cis-9-octadecenoat), ethoxyliert
  •  :9005-65-6
  •  :MFCD00082107
  •  :–21 °C
  •  :1,062 g/cm³
  •  :Management of Change (MOC) category = R
  •  :113 °C (closed cup)
  •  :Stue temperatur
  •  :500-019-9

 

 
 
 

 

  • Meets E.P. Chemical Specifications:
    ≤2.0
  • Meets B.P. Chemical Specifications:
    65 - 80
  • Meets N.F. Requirements:
    Passes Test
  • Meets J.P. Chemical Specifications:
    Passes Test
  • GMP Manufactured Product:
    ≤0.25%
  • CAUTION: For Manufacturing, processing or repackaging:
    45 - 55
  • Bulk Pharmaceutical Chemical:
    1.06 - 1.09
  • 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 %

 

  • Pakning:
    Glass bottle, amber, narrow mouth
  • Pakn:
    20 mL

 

   
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