Polysorbate 20 NF, Multi-Compendial, J.T.Baker®
Proveedor: Avantor
Management of Change (MOC) category = R
4116-03EA
2463.45
EUR
4116-03
4116-04
4116-06
4116-07
4116-02
Polysorbate 20 NF, Multi-Compendial, J.T.Baker®
Polysorbate 20
|
Formula:
C₅₈H₁₁₄O₂₆ Densidad: 1,11 g/cm³ Temperatura de almacenaje: Ambiente |
Número MDL:
MFCD00165986 Núm. CAS: 9005-64-5 EINECS: 500-018-3 |
Resultados test especificaciones
| GMP Manufactured Product | ≤2.0 |
| Meets JPE Specifications | ≤0.25% |
| Meets N.F. Requirements | ≤10 ppm |
| Meets E.P. Chemical Specifications | ≤1 ppm |
| Meets B.P. Chemical Specifications | 96 - 108 |
| Store in airtight container, protected from light | Passes Test |
| CAUTION: For Manufacturing, processing or repackaging | Passes Test |
| Bulk Pharmaceutical Chemical | 40 - 50 |
| 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 % |
| Endotoxin Concentration (EU/mL) | ≤ 10 |
| EP/BP - Acid Value | ≤ 2.0 |
| EP/BP - Total Ash | ≤ 0.25 % |
| 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 - Identification A | Passes Test |
| EP - Identification D | Passes Test |
| EP/BP - Hydroxyl Value | 96 - 108 |
| EP - Peroxide Value | ≤ 10.0 |
| EP - Saponification Value | 40 - 50 |
| EP - Water (H₂O) | ≤ 3.0 % |
| EP - Ethylene Oxide | ≤ 1 ppm |
| EP - Dioxan | ≤ 10 ppm |
| Appearance | Passes Test |
| pH of 5% Solution at 25°C | 5.0 - 7.0 |
| Arsenic (As) | ≤ 1.000 ppm |
| Peroxide Value, meqO₂/kg | ≤ 2.0 |
| 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 |
| JPE - Identification 1 | Passes Test |
| JPE - Identification 2 | Passes Test |
| JPE - Identification 3 | Passes Test |
| JPE - Moisture Content | ≤ 3.0 % |
| JPE - Acid Value | ≤ 4.0 |
| JPE - Saponification Value (mg KOH/g) | 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 |
| Ethylene glycol | ≤ 0.10 % |
| Diethylene glycol | ≤ 0.10 % |
| Vegetable Based | |
| This product utilizes ingredients of non-animal origin and non-peanut origin. | |
| Only Class 2 (1,4 Dioxane, Ethylene Glycol) and Class 3 (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%. | |
| Suitable for use in injectable dosage forms. | |
| 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. |
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