Polysorbat 80 NF, Multi-Compendial, J.T.Baker®

Specification Test Results

• Meets E.P. Chemical Specifications:
  ≤2.0
• Meets B.P. Chemical Specifications:
  65 - 80
• Meets N.F. Requirements:
  Passes Test
• Meets J.P. Chemical Specifications:
  Passes Test
• GMP Manufactured Product:
  ≤0.25%
• CAUTION: For Manufacturing, processing or repackaging:
  45 - 55
• Bulk Pharmaceutical Chemical:
  1.06 - 1.09
• 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 %
• Appearance:
  Passes Test
• 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
• Additional Tests - Color (Gardner):
  ≤ 7
• Additional Tests - Odor (Faint):
  Passes Test
• Additional Tests - Peroxide Value, meqO₂/kg:
  ≤ 2.0
• Additional Tests - Endotoxin Concentration (EU/mL):
  ≤ 10
• Free Ethylene Oxide:
  ≤ 1 ppm
• 1,4-Dioxane:
  ≤ 5 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
• Ethylene glycol:
  ≤ 0.10 %
• Diethylene glycol :
  ≤ 0.10 %