Polysorbate 20, Multi-Compendial, J.T.Baker®
Supplier: Avantor
Synonyms:
Polyoxyethylene-20-Sorbitan Monolaurate, Sorbitan monolaurate, ethoxylated
Management of Change (MOC) category = R
BAKR4115-04EA
599
SGD
BAKR4115-04
Polysorbate 20, Multi-Compendial, J.T.Baker®
Polysorbate 20
Formula:
C₅₈H₁₁₄O₂₆ Density: 1,11 g/cm³ Storage Temperature: Ambient |
MDL Number:
MFCD00165986 CAS Number: 9005-64-5 EINECS: 500-018-3 |
Specification Test Results
GMP Manufactured Product | |
Meets B.P. Chemical Specifications | |
Meets ChP Chemical Specifications | |
Meets E.P. Chemical Specifications | |
Meets JPE Specifications | |
Meets N.F. Requirements | |
CAUTION: For Manufacturing, processing or repackaging | |
Bulk Pharmaceutical Chemical | |
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 - 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 |
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 |
ChP - Relative Density @ 20 C | 1.09 - 1.12 |
ChP - Viscosity, mm2/s @ 25 C | 250 - 400 |
ChP - Acid Value,meq/g | ≤ 2.0 |
ChP - Saponification Value | 40 - 50 |
ChP - Hydroxyl Value | 96 - 108 |
ChP - Peroxide Value | ≤ 10 |
ChP - Identification 1 | Passes Test |
ChP - Identification 2 | Passes Test |
ChP - Identification 3 | Passes Test |
ChP - Acidity or Alkalinity (pH) | 4.0 - 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 - Water | ≤ 3.0 % |
ChP - Heavy Metals | ≤ 10 ppm |
ChP - Arsenic | ≤ 0.0002 % |
ChP - Fatty Acid Composition: Lauric acid | 40.0 - 60.0 % |
ChP - Fatty Acid Composition: Myristic acid | 14.0 - 25.0 % |
ChP - Fatty Acid Composition: Palmitic acid | 7.0 - 15.0 % |
ChP - Fatty Acid Composition: Caproic acid | ≤ 1.0 % |
ChP - Fatty Acid Composition: Caprylic acid | ≤ 10.0 % |
ChP - Fatty Acid Composition: Capric acid | ≤ 10.0 % |
ChP - Fatty Acid Composition: Stearic acid | ≤ 7.0 % |
ChP - Fatty Acid Composition: Oleic acid | ≤ 11.0 % |
ChP - Fatty Acid Composition: Linoleic acid | ≤ 3.0 % |
Endotoxin Concentration (EU/mL) | ≤ 10 |
Peroxide Value, meqO2/kg | ≤ 2.0 |
Appearance | Passes Test |
pH of 5% solution at 25°C | 5.0 - 7.0 |
Arsenic | ≤ 1 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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