Polysorbat 80 NF, Multi-Compendial, meets analytical specification of ChP, BP, JP, Ph. Eur., J.T.Baker®
Leverantör: Avantor
Synonyms:
Sorbitanmonooleat, etoxylerad
Management of Change (MOC) category = R
4125-04-DOC
4125-04EA
4325
SEK
4125-04
4125-06
4125-03
4125-04-DOC
Polysorbat 80 NF, Multi-Compendial, meets analytical specification of ChP, BP, JP, Ph. Eur., 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 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 |
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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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