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Polysorbate 80 (vegetable based) NF multi-compendial, Multi-Compendial, refined, J.T. Baker®

Dodávateľ: Avantor

4500-06EA 9259.09 EUR
4500-06 4500-03 4500-04
Polysorbate 80 (vegetable based) NF multi-compendial, Multi-Compendial, refined, J.T. Baker®
Polysorbate 80

Polysorbate 80 utilises ingredients of non-animal origin and non-peanut origin.


  • Typical oleic acid content, 77%
  • GMP manufactured product

Číslo MDL: MFCD00082107
Číslo CAS: 9005-65-6

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Výsledky špecifikačného testu

GMP Manufactured Product
Meets J.P. Chemical Specifications
Meets N.F. Requirements
Meets E.P. Chemical Specifications
CAUTION: For Manufacturing, processing or repackaging
Bulk Pharmaceutical Chemical
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 - 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 (APHA) ≤150
Additional Tests - Odor Passes Test
Additional Tests - Water (H₂O) ≤0.2 %
Additional Tests - Peroxide Value (meq/kg) ≤2.0
Additional Tests - Endotoxin Concentration (EU/mL) ≤2
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
1,4-Dioxane ≤5 ppm
Formaldehyde ≤10 ppm
Sodium (Na) ≤5 ppm
Potassium (K) ≤5 ppm
Vegetable Based
This product utilizes ingredients of non-animal origin and non-peanut
origin.
Suitable for use in the manufacture of parenteral dosage forms.
Only Class 2 (1,4 Dioxane, Ethylene Glycol) and Class 3 (acetic acid,
2-propanol) solvents are likely to be present. Class 2 solvents are below the Option 1 limits and any Class 3 solvent is
<0.5%.
Typical Oleic Acid Content, 77%
Metallic Residues: No metal catalysts or metal reagents, as defined by
EMA Guideline EMEA/CHMP/SWP/4446/2000 , are used in the production of
this material. Due to the anhydrous nature of this product, sodium oleate, a carboxylate salt/soap formed naturally in the process and which can be
white to brown in color, can precipitate with time and may affect
product viscosity.

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