Polysorbaatti 20 (vegetable based) NF, Multi-Compendial, refined, J.T. Baker®

Toimittaja: Avantor

Synonyms: Sorbitaanimonolauraatti, etoksiloitu

4600-06EA 7905.23 EUR
4600-06 4600-04 4600-03
Polysorbaatti 20 (vegetable based) NF, Multi-Compendial, refined, J.T. Baker®
Polysorbaatti 20
Kaava: C₅₈H₁₁₄O₂₆
Tiheys: 1,08 kg (1 L)
Leimahduspiste: 148,00 °C
MDL numero: MFCD00165986
CAS-numero: 9005-64-5

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Testitulosten erittely

GMP Manufactured Product
Meets E.P. Chemical Specifications
Meets B.P. Chemical Specifications
Meets JPE Specifications
Meets N.F. Requirements
CAUTION: For Manufacturing, processing or repackaging
Bulk Pharmaceutical Chemical
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 %
EP/BP - Acid Value ≤2.0
EP/BP - Total Ash ≤0.25 %
EP/BP - Hydroxyl Value 96 - 108
EP/BP - Identification A Passes Test
EP/BP - Identification D Passes Test
EP/BP - Saponification Value 40 - 50
EP/BP - Ethylene Oxide ≤1 ppm
EP/BP - Dioxan ≤10 ppm
EP/BP - Water (H₂O) ≤3.0 %
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 - Peroxide Value ≤10.0
JPE - Identification 1 Passes Test
JPE - Identification 2 Passes Test
JPE - Identification 3 Passes Test
JPE - pH at 25°C (5% Aqueous) 4.0 - 7.0
JPE - Water (H₂O) ≤3.0 %
JPE - Acid Value ≤4.0
JPE - Saponification Value 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
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
Endotoxin Concentration (EU/g) ≤10
Color (APHA) ≤150
Formaldehyde ≤10 ppm
Potassium (K) ≤5 ppm
Sodium (Na) ≤5 ppm
Vegetable Based
This product utilizes ingredients of non-animal origin and non-peanut origin.
Suitable for use in the manufacture of parenteral dosage forms.
Only the Class 2 solvents 1,4-dioxane (<5ppm) and ethylene glycol (<620 ppm) and the Class 3 solvent 2-propanol (<0.1%) are likely to be present.

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