Polysorbate 80 (vegetable based) NF, Multi-Compendial, refined, J.T.Baker®
Supplier: Avantor
Synonyms:
Sorbitan monooleate, ethoxylated, Polyoxyethylene-80-Sorbitan Monolaurate, Polyoxyethylene (20) sorbitan monooleate
Management of Change (MOC) category = R
4500-04EA
122296.8
INR
4500-04
4500-06
4500-03
Polysorbate 80 (vegetable based) NF, 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
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 |
Specification Test Results
GMP Manufactured Product | ≤2.0 |
Meets J.P. Chemical Specifications | ≤10 ppm |
Meets N.F. Requirements | 65 - 80 |
Meets E.P. Chemical Specifications | Passes test |
CAUTION: For Manufacturing, processing or repackaging | Passes test |
Bulk Pharmaceutical Chemical | ≤0.25% |
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 |
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. | |
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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