Polysorbate 80 NF, Multi-Compendial, J.T.Baker®

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Product Details & Documents

Vegetable based.

GMP manufactured product
Vegetable based

Suitable for use in the manufacture of parenteral dosage forms.

Sinónimos: Sorbitan monooleate, ethoxylated, Polyoxyethylene-80-Sorbitan Monolaurate, Polyoxyethylene (20) sorbitan monooleate

CAS Number:9005-65-6
Número MDL:MFCD00082107
Punto de fusión:100 °C
Densidad:1.062 g/cm³
:Management of Change (MOC) category = R
Punto de fusión:–21 °C
Punto de inflamación:113 °C (closed cup)
Temperatura de almacenamiento:Ambient
EINECS:500-019-9

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4117 Product Specifications

Resultados de prueba de especificación

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 %
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 (Gardner):
≤ 7
Additional Tests - Odor (Faint):
Passes Test
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 %

Especificaciones

Pack type:
Glass bottle, amber, narrow mouth
Size:
1 L

Especificaciones

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