Polysorbate 80 (vegetable based) NF, Multi-Compendial, refined, J.T.Baker®
: Avantor
:9005-65-6
:
:MFCD00082107
:–21 °C
:1.062 g/cm³
:Management of Change (MOC) category = R
:113 °C (closed cup)
:Ambient
:500-019-9
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- Microbiological - Staphylococcus aureus:Passes Test
- Microbiological - Total Yeast and Mold Count (cfu/g):≤50
- 1,4-Dioxane:≤5 ppm
- Ethylene glycol:≤ 0.10 %
- Diethylene glycol:≤ 0.10 %
- GMP Manufactured Product:≤2.0
- Meets J.P. Chemical Specifications:≤10 ppm
- Meets N.F. Requirements:65 - 80
- Meets E.P. Chemical Specifications:Passes test
- CAUTION: For Manufacturing, processing or repackaging:Passes test
- Bulk Pharmaceutical Chemical:≤0.25%
- 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 - Appearance:Passes Test
- 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
- Additional Tests - Color (APHA):≤150
- Additional Tests - Odor:Passes Test
- Additional Tests - Water (H₂O):≤0.2 %
- Additional Tests - Peroxide Value (meq/kg):≤2.0
- Additional Tests - Endotoxin Concentration (EU/mL):≤2
- Microbiological - Total Aerobic Microbial Count (cfu/g):≤100
- Microbiological - Escherichia coli:Passes Test
- Microbiological - Pseudomonas aeruginosa:Passes Test
- Microbiological - Salmonella:Passes Test