Polysorbate 20, Multi-Compendial

Specification Test Results

• 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 - 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
• 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
• ChP - Relative Density @ 20 C:
  1.09 - 1.12
• ChP - Viscosity, mm2/s @ 25 C:
  250 - 400
• ChP - Acid Value,meq/g:
  ≤ 2.0
• ChP - Saponification Value:
  40 - 50
• ChP - Hydroxyl Value:
  96 - 108
• ChP - Peroxide Value:
  ≤ 10
• ChP - Identification 1:
  Passes Test
• ChP - Identification 2:
  Passes Test
• ChP - Identification 3:
  Passes Test
• ChP - Acidity or Alkalinity (pH):
  4.0 - 7.5
• ChP - Color:
  Passes Test
• ChP - Ethylene glycol:
  ≤ 0.01 %
• ChP - Diethylene glycol:
  ≤ 0.01 %
• ChP - Ethylene Oxide:
  ≤ 0.0001 %
• ChP - Dioxane:
  ≤ 0.001 %
• ChP - Water:
  ≤ 3.0 %
• ChP - Heavy Metals:
  ≤ 10 ppm
• ChP - Arsenic:
  ≤ 0.0002 %
• ChP - Fatty Acid Composition: Lauric acid:
  40.0 - 60.0 %
• ChP - Fatty Acid Composition: Myristic acid:
  14.0 - 25.0 %
• ChP - Fatty Acid Composition: Palmitic acid:
  7.0 - 15.0 %
• ChP - Fatty Acid Composition: Caproic acid:
  ≤ 1.0 %
• ChP - Fatty Acid Composition: Caprylic acid:
  ≤ 10.0 %
• ChP - Fatty Acid Composition: Capric acid:
  ≤ 10.0 %
• ChP - Fatty Acid Composition: Stearic acid:
  ≤ 7.0 %
• ChP - Fatty Acid Composition: Oleic acid:
  ≤ 11.0 %
• ChP - Fatty Acid Composition: Linoleic acid:
  ≤ 3.0 %
• Endotoxin Concentration (EU/mL):
  ≤ 10
• Peroxide Value, meqO2/kg:
  ≤ 2.0
• Appearance:
  Passes Test
• pH of 5% solution at 25°C:
  5.0 - 7.0
• Arsenic:
  ≤ 1 ppm
• Ethylene glycol:
  ≤ 0.10 %
• Diethylene glycol :
  ≤ 0.10 %