Polysorbate 20 NF, Multi-Compendial, J.T.Baker®
: Avantor
: Polyoxyethylene-20-Sorbitan Monolaurate, Sorbitan monolaurate, ethoxylated
- :9005-64-5
- :C₅₈H₁₁₄O₂₆
- :MFCD00165986
- :1,11 g/cm³
- :Management of Change (MOC) category = R
- :Ambient
- :500-018-3
- :0000
: Polyoxyethylene-20-Sorbitan Monolaurate, Sorbitan monolaurate, ethoxylated
- :9005-64-5
- :C₅₈H₁₁₄O₂₆
- :MFCD00165986
- :1,11 g/cm³
- :Management of Change (MOC) category = R
- :Ambient
- :500-018-3
- :0000
- 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
- 포장 유형Pk
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