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

Supplier: AVANTOR PERFORMANCE MATERIALS

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Management of Change (MOC) category = R

4116-03EA 778281.4 INR InStock
4116-03 4116-04 4116-06 4116-07 4116-02
Polysorbate 20 NF, Multi-Compendial, J.T.Baker®
Polysorbate 20


Formula: C₅₈H₁₁₄O₂₆
Density: 1.11 g/cm³
Storage Temperature: Ambient
 MDL Number: MFCD00165986
CAS Number: 9005-64-5
EINECS: 500-018-3
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Specification Test Results
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 %
Vegetable Based
This product utilizes ingredients of non-animal origin and non-peanut origin.
Only Class 2 (1,4 Dioxane, Ethylene Glycol) and Class 3 (2-propanol) solvents are likely to be present. Class 2 solvents are below the Option 1 limits and any Class 3 solvent is <0.5%.
Suitable for use in injectable dosage forms.
Elemental Impurities (USP 232, EP 5.20) - Information on elemental impurities for this product is available on the associated Product Regulatory Data Sheet and elemental impurity profile report.

 

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