Polysorbate 80 NF, Multi-Compendial, meets analytical specification of ChP, BP, JP, Ph. Eur.

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Specifications

Environmentally Preferable:

Specifications

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%
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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