Polysorbate 20 NF, Multi-Compendial, J.T.Baker®

: Avantor

: Avantor

: Polyoxyethylene-20-Sorbitan Monolaurate, Sorbitan monolaurate, ethoxylated

:9005-64-5
:C₅₈H₁₁₄O₂₆
:MFCD00165986
:1,11 g/cm³
:Gestion du changement (MOC) catégorie = R
:Température ambiante
:500-018-3

: Polyoxyethylene-20-Sorbitan Monolaurate, Sorbitan monolaurate, ethoxylated

:9005-64-5
:C₅₈H₁₁₄O₂₆
:MFCD00165986
:1,11 g/cm³
:Gestion du changement (MOC) catégorie = R
:Température ambiante
:500-018-3

Documents

FDS

sds_BAKR4116

Spécification du produit

GMP Manufactured Product:
≤2.0
Meets JPE Specifications:
≤0.25%
Meets N.F. Requirements:
≤10 ppm
Meets E.P. Chemical Specifications:
≤1 ppm
Meets B.P. Chemical Specifications:
96 - 108
Store in airtight container, protected from light:
Passes Test
CAUTION: For Manufacturing, processing or repackaging:
Passes Test
Bulk Pharmaceutical Chemical:
40 - 50
NF - Acid Value:
≤ 2.0
NF - Residue on Ignition:
≤ 0.25 %
NF - Dioxane:
≤ 10 ppm
NF - Ethylene Oxide:
≤ 1 ppm
NF - Hydroxyl Value, mg KOH/g:
96 - 108
NF - Identification A:
Passes Test
NF - Identification B:
Passes Test
NF - Saponification Value, mg KOH/g:
40 - 50
NF - Caproic Acid (Composition of Fatty Acids):
≤ 1.0 %
NF - Caprylic Acid (Composition of Fatty Acids):
≤ 10.0 %
NF - Capric Acid (Composition of Fatty Acids):
≤ 10.0 %
NF - Lauric Acid (Composition of Fatty Acids):
40.0 - 60.0 %
NF - Myristic Acid (Composition of Fatty Acids):
14.0 - 25.0 %
NF - Palmitic Acid (Composition of Fatty Acids):
7.0 - 15.0 %
NF - Stearic Acid (Composition of Fatty Acids):
≤ 11.0 %
NF - Oleic Acid (Composition of Fatty Acids):
≤ 11.0 %
NF - Linoleic Acid (Composition of Fatty Acids):
≤ 3.0 %
NF - Peroxide Value:
≤ 5.0
NF - Water (H₂O):
≤ 3.0 %
Endotoxin Concentration (EU/mL):
≤ 10
EP/BP - Acid Value:
≤ 2.0
EP/BP - Total Ash:
≤ 0.25 %
EP/BP - Composition of Fatty Acids - Caproic Acid:
≤ 1.0 %
EP/BP - Composition of Fatty Acids - Caprylic Acid:
≤ 10.0 %
EP/BP - Composition of Fatty Acids - Capric Acid:
≤ 10.0 %
EP/BP - Composition of Fatty Acids - Lauric Acid:
40.0 - 60.0 %
EP/BP - Composition of Fatty Acids - Myristic Acid:
14.0 - 25.0 %
EP/BP -Composition of Fatty Acids - Palmitic Acid:
7.0 - 15.0 %
EP/BP - Composition of Fatty Acids - Stearic Acid:
≤ 7.0 %
EP/BP - Composition of Fatty Acids - Oleic Acid:
≤ 11.0 %
EP/BP - Composition of Fatty Acids - Linoleic Acid:
≤ 3.0 %
EP - Identification A:
Passes Test
EP - Identification D:
Passes Test
EP/BP - Hydroxyl Value:
96 - 108
EP - Peroxide Value:
≤ 10.0
EP - Saponification Value:
40 - 50
EP - Water (H₂O):
≤ 3.0 %
EP - Ethylene Oxide:
≤ 1 ppm
EP - Dioxan:
≤ 10 ppm
Appearance:
Passes Test
pH of 5% Solution at 25°C:
5.0 - 7.0
Arsenic (As):
≤ 1.000 ppm
Peroxide Value, meqO₂/kg:
≤ 2.0
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
JPE - Identification 1:
Passes Test
JPE - Identification 2:
Passes Test
JPE - Identification 3:
Passes Test
JPE - Moisture Content:
≤ 3.0 %
JPE - Acid Value:
≤ 4.0
JPE - Saponification Value (mg KOH/g):
43 - 55
JPE - pH:
4.0 - 7.0
JPE - Residue on Ignition:
≤ 0.25 %
JPE - Specific Gravity at 20°C:
1.090 - 1.130
JPE - Viscosity (mm²/S):
350 - 550
JPE - Heavy Metals (as Pb):
≤ 20 ppm
JPE - Arsenic (As):
≤ 2 ppm
Ethylene glycol:
≤ 0.10 %
Diethylene glycol :
≤ 0.10 %

Product Family Options

Type de conditionnement
Cdt
4116-02

Flacon Verre
20 mL

1 * 20 mL
1 * 20 mL - 159,35 €
159,35 €
1 * 20 mL
159,35 €
4116-04

Flacon Verre
200 mL

1 * 200 mL
1 * 200 mL - 197,38 €
197,38 €
1 * 200 mL
197,38 €
4116-06

Flacon Verre
1 L

1 * 1 L
1 * 1 L - 836,14 €
836,14 €
1 * 1 L
836,14 €
4116-03

Flacon Verre
4 L

1 * 4 L
1 * 4 L - 2 664,47 €
2 664,47 €
1 * 4 L
2 664,47 €
4116-07

Steel drum, phenolic lined
21,09 kg

1 * 19 L
1 * 19 L - 13 105,09 €
13 105,09 €
1 * 19 L
13 105,09 €