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

Specification Test Results

• GMP Manufactured Product:
  ≤2.0
• Meets E.P. Chemical Specifications:
  ≤0.25%
• Meets B.P. Chemical Specifications:
  ≤10 ppm
• Meets JPE Specifications:
  ≤1 ppm
• Meets N.F. Requirements:
  ≤10 ppm
• CAUTION: For Manufacturing, processing or repackaging:
  96 - 108
• Bulk Pharmaceutical Chemical:
  Passes Test
• 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
• Ethylene glycol:
  ≤ 0.10 %
• Diethylene glycol:
  ≤ 0.10 %