Specification Test Results

• ChP - Identification 2:
  Passes Test
• ChP - Identification 3:
  Passes Test
• ChP - Identification 4:
  Passes Test
• ChP - Acidity or Alkalinity:
  5.0 - 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 - Freezing Test:
  Passes Test
• ChP - Residue on ignition:
  ≤ 0.2 %
• ChP - Heavy Metals:
  ≤ 0.001 %
• ChP - Arsenic (As):
  ≤ 0.0002 %
• ChP - Fatty acid composition: oleic acid:
  ≥ 58.0 %
• ChP - Fatty Acid Composition: myristic acid:
  ≤ 5.0 %
• ChP - Fatty Acid Composition: palmitic acid:
  ≤ 16.0 %
• ChP - Fatty Acid Composition: palmitoleic acid:
  ≤ 8.0 %
• ChP - Fatty Acid Composition: stearic acid:
  ≤ 6.0 %
• ChP - Fatty Acid Composition: linoleic acid:
  ≤ 18.0 %
• ChP - Fatty Acid Composition: linolenic acid:
  ≤ 4.0 %
• Additional Tests - Endotoxin Concentration (EU/mL):
  ≤ 10
• Microbiological - Total Aerobic Microbial Count (cfu/g):
  ≤ 100
• Microbiological - Escherichia Coli
  Microbiological - Pseudomonas aeruginosa
  Microbiological - Salmonella
  Microbiological - Staphylococcus aureus:
  Passes Test
• Microbiological - Total Yeast and Mold Count (cfu/g):
  ≤ 50
• Ethylene glycol:
  ≤ 0.10 %
• Diethylene glycol:
  ≤ 0.10 %
• Vegetable Based:
• This product utilizes ingredients of non-animal origin and non-peanut origin.
  Suitable for use in the manufacture of parenteral dosage forms:
• Elemental Impurities (USP 232, EP 5.20)
  Information on elemental impurities for this product is available on the associated Product:
  Only Class 2 (1,4 Dioxane, Ethylene Glycol) and Class 3 (acetic acid, 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%
  Typical Oleic Acid Content, 77%
• undefined:
  Regulatory Data Sheet and elemental impurity profile report
  Due to the anhydrous nature of this product, sodium oleate, a carboxylate salt/soap formed naturally in the process and which can be white to brown in color, can precipitate with time and may affect product viscosity
• Meets B.P. Chemical Specifications:
• Meets ChP Chemical Specifications:
• Meets E.P. Chemical Specifications:
• Meets J.P. Chemical Specifications:
• Meets N.F. Requirements:
• GMP Manufactured Product:
• CAUTION: For Manufacturing, processing or repackaging:
• Bulk Pharmaceutical Chemical:
• NF - Acid Value:
  ≤ 2.0
• NF - Hydroxyl Value:
  65 - 80
• NF - Identification A:
  Passes Test
• NF - Identification B:
  Passes Test
• NF - Residue on Ignition:
  ≤ 0.25 %
• NF - Saponification Value:
  45 - 55
• NF - Specific Gravity at 25°C:
  1.06 - 1.09
• NF - Viscosity at 25°C, cSt:
  300 - 500
• NF - Water (H₂O):
  ≤ 3.0 %
• NF - Peroxide Value:
  ≤ 10.0
• NF - Ethylene Oxide:
  ≤ 1 ppm
• NF - Dioxane:
  ≤ 10 ppm
• NF - Composition of Fatty Acids - Myristic Acid:
  ≤ 5.0 %
• NF - Composition of Fatty Acids - Palmitic Acid:
  ≤ 16.0 %
• NF - Composition of Fatty Acids - Palmitoleic Acid:
  ≤ 8.0 %
• NF - Composition of Fatty Acids - Stearic Acid:
  ≤ 6.0 %
• NF - Composition of Fatty Acids - Oleic Acid:
  ≥ 58.0 %
• NF - Composition of Fatty Acids - Linoleic Acid:
  ≤ 18.0 %
• NF - Composition of Fatty Acids - Linolenic Acid:
  ≤ 4.0 %
• EP - Acid Value:
  ≤ 2.0
• EP - Total Ash:
  ≤ 0.25 %
• EP - Hydroxyl Value:
  65 - 80
• EP - Identification A:
  Passes Test
• EP - Identification D:
  Passes Test
• EP - Peroxide Value:
  ≤ 10.0
• EP - Ethylene Oxide:
  ≤ 1 ppm
• EP - Dioxan:
  ≤ 10 ppm
• EP - Saponification Value:
  45 - 55
• EP - Water (H₂O):
  ≤ 3.0 %
• EP/BP - Composition of Fatty Acids - Myristic Acid:
  ≤ 5.0 %
• EP/BP - Composition of Fatty Acids - Palmitic Acid:
  ≤ 16.0 %
• EP/BP - Composition of Fatty Acids - Palmitoleic Acid:
  ≤ 8.0 %
• EP/BP - Composition of Fatty Acids - Stearic Acid:
  ≤ 6.0 %
• EP/BP - Composition of Fatty Acids - Oleic Acid:
  ≥ 58.0 %
• EP/BP - Composition of Fatty Acids - Linoleic Acid:
  ≤ 18.0 %
• EP/BP - Composition of Fatty Acids - Linolenic Acid:
  ≤ 4.0 %
• JP - Acid Value:
  ≤ 2.0
• JP - Composition of Fatty Acids - Myristic Acid:
  ≤ 5.0 %
• JP - Composition of Fatty Acids - Palmitic Acid:
  ≤ 16.0 %
• JP - Composition of Fatty Acids - Palmitoleic Acid:
  ≤ 8.0 %
• JP - Composition of Fatty Acids - Stearic Acid:
  ≤ 6.0 %
• JP - Composition of Fatty Acids - Oleic Acid:
  ≥ 58.0 %
• JP - Composition of Fatty Acids - Linoleic Acid:
  ≤ 18.0 %
• JP - Composition of Fatty Acids - Linolenic Acid:
  ≤ 4.0 %
• JP - Dioxane:
  ≤ 10 ppm
• JP - Ethylene Oxide:
  ≤ 1 ppm
• JP - Heavy Metals (as Pb):
  ≤ 20 ppm
• JP - Hydroxyl Value, meq KOH/g:
  65 - 80
• JP - Identification:
  Passes Test
• JP - Peroxide Value:
  ≤ 10.0
• JP - Residue on Ignition:
  ≤ 0.25 %
• JP - Water (H₂O):
  ≤ 3.0 %
• JP - Saponification Value:
  45 - 55
• ChP - Relative Density @ 20 °C:
  1.06 - 1.09
• ChP - Viscosity @ 25 °C:
  350 - 550 mm2/s
• ChP - Acid Value:
  ≤ 2.0
• ChP - Saponification Value:
  45 - 55
• ChP - Hydroxyl Value:
  65 - 80
• ChP - Iodine Value:
  18 - 24
• ChP - Peroxide Value:
  ≤ 10
• ChP - Identification 1:
  Passes Test
• J.T.Baker®, Polysorbate 80 NF, Multi-Compendial, meets analytical specification of ChP, BP, JP, Ph. Eur.: