Polysorbate 20 vegetal NF, Multi-Compendial, refinado, J.T.Baker®
Proveedor: Avantor
4600-04EA
1881.01
EUR
4600-04
4600-03
4600-06
Polysorbate 20 vegetal NF, Multi-Compendial, refinado, J.T.Baker®
Polysorbate 20
|
Formula:
C₅₈H₁₁₄O₂₆ Densidad: 1,08 kg (1 L) Pto. de inflamación: 148,00 °C |
Número MDL:
MFCD00165986 Núm. CAS: 9005-64-5 |
Resultados test especificaciones
| GMP Manufactured Product | ≤2.0 |
| Meets E.P. Chemical Specifications | ≤0.25% |
| Meets B.P. Chemical Specifications | ≤10 ppm |
| Meets JPE Specifications | ≤1 ppm |
| Meets N.F. Requirements | ≤10 ppm |
| CAUTION: For Manufacturing, processing or repackaging | 96 - 108 |
| Bulk Pharmaceutical Chemical | Passes Test |
| NF - Acid Value | ≤2.0 |
| NF - Residue on Ignition | ≤0.25 % |
| NF - Dioxane | ≤10 ppm |
| NF - Ethylene Oxide | ≤1 ppm |
| NF - Hydroxyl Value, mg KOH/g | 96 - 108 |
| NF - Identification A | Passes Test |
| NF - Identification B | Passes Test |
| NF - Saponification Value, mg KOH/g | 40 - 50 |
| NF - Caproic Acid (Composition of Fatty Acids) | ≤1.0 % |
| NF - Caprylic Acid (Composition of Fatty Acids) | ≤10.0 % |
| NF - Capric Acid (Composition of Fatty Acids) | ≤10.0 % |
| NF - Lauric Acid (Composition of Fatty Acids) | 40.0 - 60.0 % |
| NF - Myristic Acid (Composition of Fatty Acids) | 14.0 - 25.0 % |
| NF - Palmitic Acid (Composition of Fatty Acids) | 7.0 - 15.0 % |
| NF - Stearic Acid (Composition of Fatty Acids) | ≤11.0 % |
| NF - Oleic Acid (Composition of Fatty Acids) | ≤11.0 % |
| NF - Linoleic Acid (Composition of Fatty Acids) | ≤3.0 % |
| NF - Peroxide Value | ≤5.0 |
| NF - Water (H₂O) | ≤3.0 % |
| EP/BP - Acid Value | ≤2.0 |
| EP/BP - Total Ash | ≤0.25 % |
| EP/BP - Hydroxyl Value | 96 - 108 |
| EP/BP - Identification A | Passes Test |
| EP/BP - Identification D | Passes Test |
| EP/BP - Saponification Value | 40 - 50 |
| EP/BP - Ethylene Oxide | ≤1 ppm |
| EP/BP - Dioxan | ≤10 ppm |
| EP/BP - Water (H₂O) | ≤3.0 % |
| EP/BP - Composition of Fatty Acids - Caproic Acid | ≤1.0 % |
| EP/BP - Composition of Fatty Acids - Caprylic Acid | ≤10.0 % |
| EP/BP - Composition of Fatty Acids - Capric Acid | ≤10.0 % |
| EP/BP - Composition of Fatty Acids - Lauric Acid | 40.0 - 60.0 |
| EP/BP - Composition of Fatty Acids - Myristic Acid | 14.0 - 25.0 % |
| EP/BP - Composition of Fatty Acids - Palmitic Acid | 7.0 - 15.0 |
| EP/BP - Composition of Fatty Acids - Stearic Acid | ≤7.0 % |
| EP/BP - Composition of Fatty Acids - Oleic Acid | ≤11.0 % |
| EP/BP - Composition of Fatty Acids - Linoleic Acid | ≤3.0 % |
| EP - Peroxide Value | ≤10.0 |
| JPE - Identification 1 | Passes Test |
| JPE - Identification 2 | Passes Test |
| JPE - Identification 3 | Passes Test |
| JPE - pH at 25°C (5% Aqueous) | 4.0 - 7.0 |
| JPE - Water (H₂O) | ≤3.0 % |
| JPE - Acid Value | ≤4.0 |
| JPE - Saponification Value | 43 - 55 |
| JPE - pH | 4.0 - 7.0 |
| JPE - Residue on Ignition | ≤0.25 % |
| JPE - Specific Gravity at 20°C | 1.090 - 1.130 |
| JPE - Viscosity (mm²/S) | 350 - 550 |
| JPE - Heavy Metals (as Pb) | ≤20 ppm |
| JPE - Arsenic (As) | ≤2 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 |
| Endotoxin Concentration (EU/g) | ≤10 |
| Color (APHA) | ≤150 |
| Formaldehyde | ≤10 ppm |
| Potassium (K) | ≤5 ppm |
| Sodium (Na) | ≤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 the Class 2 solvents 1,4-dioxane (<5ppm) and ethylene glycol (<620 ppm) and the Class 3 solvent 2-propanol (<0.1%) are likely to be present. |
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