Polysorbate 80 NF, Multi-Compendial, J.T.Baker®
Supplier: Avantor
Synonyms:
Sorbitan monooleate, ethoxylated, Polyoxyethylene-80-Sorbitan Monolaurate, Polyoxyethylene (20) sorbitan monooleate
Management of Change (MOC) category = R
BS25-04EA
0
INR
BS25-04
BS25-SA
Polysorbate 80 NF, Multi-Compendial, J.T.Baker®
Polysorbate 80
Flash Pt:
148,0 °C Storage Temperature: Ambient |
MDL Number:
MFCD00082107 CAS Number: 9005-65-6 |
Specification Test Results
Meets B.P. Chemical Specifications | |
Meets N.F. Requirements | |
Meets E.P. Chemical Specifications | |
Meets J.P. Chemical Specifications | |
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, meq/kg | ≤ 10 |
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 |
Microbiological - Total Aerobic Microbial Count (cfu/g) | ≤ 100 |
Microbiological - Total Yeast and Mold Count (cfu/g) | ≤ 50 |
Residual Solvents - Ethylene Glycol, For Information Only | |
Residual Solvents - Acetic Acid, For Information Only | |
Residual Solvents - 2-Propanol, For Information Only | |
Bacterial endotoxins, EU/mL | ≤ 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. | |
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% | |
Elemental Impurities (USP 232, EP 5.20) - Information on elemental impurities for this product is available on the associated Product Regulatory Data Sheet and elemental impurity profile report. | |
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. |
Learn more
About VWR
Avantor is a vertically integrated, global supplier of discovery-to-delivery solutions for...