Polysorbat 80 NF, Multi-Compendial, J.T.Baker®
Leverantör: Avantor
Synonyms:
Sorbitanmonooleat, etoxylerad
Management of Change (MOC) category = R
4117-03EA
39150
SEK
4117-03
4117-04
4117-06
4117-12
4117-07
4117-02
Polysorbat 80 NF, Multi-Compendial, J.T.Baker®
Polysorbat 80
- GMP manufactured product
- Vegetable based
Suitable for use in the manufacture of parenteral dosage forms.
|
Smältpunkt:
–21 °C Densitet: 1,062 g/cm³ Flampunkt: 113 °C (closed cup) Storage Temperature: Omgivande |
MDL Number:
MFCD00082107 CAS nummer: 9005-65-6 EINECS: 500-019-9 |
Specifikation testresultat
| Meets E.P. Chemical Specifications | ≤2.0 |
| Meets B.P. Chemical Specifications | 65 - 80 |
| Meets N.F. Requirements | Passes Test |
| Meets J.P. Chemical Specifications | Passes Test |
| GMP Manufactured Product | ≤0.25% |
| CAUTION: For Manufacturing, processing or repackaging | 45 - 55 |
| Bulk Pharmaceutical Chemical | 1.06 - 1.09 |
| 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 % |
| 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 (Gardner) | ≤ 7 |
| Additional Tests - Odor (Faint) | Passes Test |
| 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 |
| 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 |
| Residual Solvents - Ethylene Glycol, For Information Only | |
| Residual Solvents - Acetic Acid, For Information Only | |
| Residual Solvents - 2-Propanol, For Information Only | |
| 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. |
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