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
4113-06EA
116402.42
INR
4113-06
Polysorbate 80 NF, Multi-Compendial, J.T.Baker®
Polysorbate 80
|
Storage Temperature:
Refrigerator |
MDL Number:
MFCD00082107 CAS Number: 9005-65-6 |
Specification Test Results
| GMP Manufactured Product | |
| Meets N.F. Requirements | |
| Meets E.P. Chemical Specifications | |
| Meets J.P. Chemical Specifications | |
| Meets B.P. Chemical Specifications | |
| Store at 2 - 8 °C | |
| 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 | ≤2.0 |
| 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 |
| Appearance (yellow to dark amber, viscous liquid) | Passes Test |
| Additional Tests - Color (Gardner) | ≤7 |
| Additional Tests - Odor (Faint) | Passes Test |
| Additional Tests - Water (H₂O) | ≤0.2 % |
| 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 |
| ≤ 0.10 % | Ethylene Glycol |
| Microbiological – Total aerobic microbial count (cfu/g) | Diethylene Glycol |
| Microbiological – Total yeast and mold count (cfu/g) | ≤100 cfu/g |
| Microbiological - Escherichia Coli | Passes Test |
| Microbiological - Pseudomonas aeruginosa | Passes Test |
| Microbiological - Salmonella | Passes Test |
| Microbiological - Staphylococcus aureus | Passes Test |
| Residual Solvents - Ethylene Glycol | ≤620 ppm |
| Residual Solvents - Acetic Acid | ≤5000 ppm |
| Residual Solvents - 2-Propanol | ≤5000 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. | |
| Residual Solvents - 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 – All elemental impurities listed in USP 232 and EP 5.20 are below the Option 1 limits. A detailed elemental impurity profile is available for this product on request. | |
| 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. | |
| Product packed under nitrogen. | |
| Store in airtight container, protected from light. |
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