(oh lay' ik as' id).
Oleic Acid is manufactured from fats and oils derived from edible sources, animal or vegetable, and consists chiefly of (Z)-9-octadecenoic acid [CH3(CH2)7CH:CH(CH2)7COOH]. It may contain suitable stabilizers.
[NoteOleic Acid labeled solely for external use is exempt from the requirement that it be prepared from edible sources. ]
• Infrared Absorption 197F
Sample: Undried specimen
Acceptance criteria: Meets the requirements
• Residue on Ignition 281
Sample: 10 mL
Acceptance criteria: NMT 1 mg (about 0.01%)
• Specific Gravity 841: 0.8890.895
• Congealing Temperature 651: 3 to 10 for Oleic Acid derived from animal sources; 10 to 16 for Oleic Acid derived from vegetable sources
• Fats and Fixed Oils, Acid Value 401: 196204, 2 g being used
• Mineral Acids
Sample: 5 mL
Analysis: Shake the Sample with an equal volume of water at a temperature of about 25 for 2 min, allow the liquids to separate, and pass the water layer through a paper filter previously moistened with water.
Acceptance criteria: The filtrate is not reddened by the addition of 1 drop of methyl orange TS.
• Neutral Fat or Mineral Oil
Sample: 1 mL
Analysis: Boil the Sample with 500 mg of sodium carbonate and 30 mL of water in a 250-mL flask.
Acceptance criteria: The resulting solution, while hot, is clear or, at most, opalescent.
• Packaging and Storage: Preserve in tight containers.
• Labeling: If it is for external use only, the labeling so indicates. Label it to indicate whether it is derived from animal or vegetable sources. Indicate the names and quantity of any added stabilizers.
• USP Reference Standards 11
Auxiliary Information Please check for your question in the FAQs before contacting USP.
USP35NF30 Page 1877Pharmacopeial Forum: Volume No. 32(6) Page 1771