Polysorbate 80 NF, Multi-Compendial, meets analytical specification of ChP, BP, JP, Ph. Eur., J.T.Baker®

Supplier: Avantor

Synonyms: Sorbitan monooleate, ethoxylated, Polyoxyethylene-80-Sorbitan Monolaurate, Polyoxyethylene (20) sorbitan monooleate

Management of Change (MOC) category = R

4125-04EA 30563 INR
4125-04 4125-QM 4125-06 4125-03
Polysorbate 80 NF, Multi-Compendial, meets analytical specification of ChP, BP, JP, Ph. Eur., J.T.Baker®
Polysorbate 80

  • GMP manufactured product
  • Vegetable based


Suitable for use in the manufacture of parenteral dosage forms.

Melting Pt: –21 °C
Density: 1,062 g/cm³
Flash Pt: 113 °C (closed cup)
Storage Temperature: Ambient
MDL Number: MFCD00082107
CAS Number: 9005-65-6
EINECS: 500-019-9

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Specification Test Results

Meets B.P. Chemical Specifications
Meets ChP Chemical Specifications
Meets E.P. Chemical Specifications
Meets J.P. Chemical Specifications
Meets N.F. Requirements
GMP Manufactured Product
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 - 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
ChP - Relative Density @ 20 °C 1.06 - 1.09
ChP - Viscosity @ 25 °C 350 - 550 mm2/s
ChP - Acid Value ≤ 2.0
ChP - Saponification Value 45 - 55
ChP - Hydroxyl Value 65 - 80
ChP - Iodine Value 18 - 24
ChP - Peroxide Value ≤ 10
ChP - Identification 1 Passes Test
ChP - Identification 2 Passes Test
ChP - Identification 3 Passes Test
ChP - Identification 4 Passes Test
ChP - Acidity or Alkalinity 5.0 - 7.5
ChP - Color Passes Test
ChP - Ethylene glycol ≤ 0.01 %
ChP - Diethylene glycol ≤ 0.01 %
ChP - Ethylene oxide ≤ 0.0001 %
ChP - Dioxane ≤ 0.001 %
ChP - Freezing Test Passes Test
ChP - Water ≤ 3.0 %
ChP - Residue on ignition ≤ 0.2 %
ChP - Heavy Metals ≤ 0.001 %
ChP - Arsenic (As) ≤ 0.0002 %
ChP - Fatty acid composition: oleic acid ≥ 58.0 %
ChP - Fatty Acid Composition: myristic acid ≤ 5.0 %
ChP - Fatty Acid Composition: palmitic acid ≤ 16.0 %
ChP - Fatty Acid Composition: palmitoleic acid ≤ 8.0 %
ChP - Fatty Acid Composition: stearic acid ≤ 6.0 %
ChP - Fatty Acid Composition: linoleic acid ≤ 18.0 %
ChP - Fatty Acid Composition: linolenic acid ≤ 4.0 %
Additional Tests - Endotoxin Concentration (EU/mL) ≤ 10
Microbiological - Total Aerobic Microbial Count (cfu/g) ≤ 100
Microbiological - Escherichia Coli
Microbiological - Pseudomonas aeruginosa
Microbiological - Salmonella
Microbiological - Staphylococcus aureus
Passes Test
Microbiological - Total Yeast and Mold Count (cfu/g) ≤ 50
Ethylene glycol ≤ 0.10 %
Diethylene glycol ≤ 0.10 %
Vegetable Based
This product utilizes ingredients of non-animal origin and non-peanut origin.
Suitable for use in the manufacture of parenteral dosage forms
Elemental Impurities (USP 232, EP 5.20)
Information on elemental impurities for this product is available on the associated Product
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%

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