Polysorbate 80 NF, Multi-Compendial, J.T.Baker®
About this item
Vegetable based.
- GMP manufactured product
- Vegetable based
Suitable for use in the manufacture of parenteral dosage forms.
- CAS Number:9005-65-6
- MDL Number:MFCD00082107
- Melting Pt:100 °C
- Density:1.062 g/cm³
- :Management of Change (MOC) category = R
- Melting Pt:–21 °C
- Flash Pt:113 °C (closed cup)
- Storage Temperature:Température ambiante
- EINECS:500-019-9
5 Options Available Below
Product Details & Documents
Vegetable based.
- GMP manufactured product
- Vegetable based
Suitable for use in the manufacture of parenteral dosage forms.
- CAS Number:9005-65-6
- MDL Number:MFCD00082107
- Melting Pt:100 °C
- Density:1.062 g/cm³
- :Management of Change (MOC) category = R
- Melting Pt:–21 °C
- Flash Pt:113 °C (closed cup)
- Storage Temperature:Température ambiante
- EINECS:500-019-9
Specifications for Product Family
Specification Test Results
- 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
- Additional Tests - Color (Gardner):≤7
- Additional Tests - Odor (Faint):Passes Test
- Additional Tests - Water (H₂O):≤0.2%
- Additional Tests - Peroxide Value, meqO₂/kg:≤2.0
- Additional Tests - Endotoxin Concentration (EU/ml):≤10
- Free Ethylene Oxide:≤1 ppm
- 1,4-Dioxane:≤5 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
- Ethylene glycol:≤ 0.10 %
- Diethylene glycol :≤ 0.10 %
Product Family Options
Product Information
- Type de conditionnementTailleAvailabilityPrice
- Supplier Number: BAKR4117-02Specifications:MOC: RegulatedMOC: Regulated
- Supplier Number: BAKR4117-04Specifications:MOC: RegulatedMOC: Regulated
- Glass bottle, amber, narrow mouth, septum-sealed1 LDiscontinued-Supplier Number: -Specifications:MOC: RegulatedMOC: Regulated
- Glass bottle, amber, narrow mouth1 LEach (1l)Case of 6 (1l)Supplier Number: BAKR4117-06Specifications:MOC: RegulatedMOC: Regulated
- Supplier Number: BAKR4117-03Specifications:MOC: RegulatedMOC: Regulated
- Supplier Number: BAKR4117-07Specifications:MOC: RegulatedMOC: Regulated
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