Polysorbate 80 NF, Multi-Compendial, meets analytical specification of ChP, BP, JP, Ph. Eur., J.T.Baker®
Supplier: Avantor
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About this item
CAS Number:9005-65-6
:
MDL Number:MFCD00082107
Melting Pt:–21 °C
Density:1.062 g/cm³
:Management of Change (MOC) category = R
Flash Pt:113 °C (closed cup)
Storage Temperature:Ambient
EINECS:500-019-9
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Specification Test Results
- 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 - Water:≤ 3.0 %
- ChP - Freezing Test:Passes Test
- 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 %
- 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% - undefined: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 - 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
Specification Test Results
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