Specification Test Results

• 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 injectable dosage forms.:
• Only Class 2 (1,4 Dioxane, Ethylene Glycol) and Class 3 (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%.:
• Elemental Impurities (USP 232, EP 5.20) - Information on elemental impurities for this product is available on the associated Product Regulatory Data Sheet and elemental impurity profile report.:
• GMP Manufactured Product:
• Meets JPE Specifications:
• Meets N.F. Requirements:
• Meets E.P. Chemical Specifications:
• Meets B.P. Chemical Specifications:
• Store in airtight container, protected from light:
• 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 %
• Endotoxin Concentration (EU/mL):
  ≤ 10
• 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
• Appearance:
  Passes Test
• pH of 5% Solution at 25°C:
  5.0 - 7.0
• Arsenic (As):
  ≤ 1.000 ppm
• Peroxide Value, meqO₂/kg:
  ≤ 2.0
• 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
• J.T.Baker®, Polysorbate 20 NF, Multi-Compendial: