Oleic Acid
(oh lay' ik as' id).
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C18 H34 O2 282.46
9-Octadecenoic acid, (Z)-;    
Oleic acid     [112-80-1].
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.
[Note—Oleic 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: 0.889–0.895
•  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: 196–204, 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
USP Oleic Acid RS Click to View Structure
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Robert H. Lafaver, M.S.
Scientific Liaison
(EXC2010) Monographs - Excipients
Reference Standards RS Technical Services
USP35–NF30 Page 1877
Pharmacopeial Forum: Volume No. 32(6) Page 1771