Oleic Acid
C18 H34 O2 282.46
9-Octadecenoic acid, (Z)-;
Oleic acid
[112-80-1].
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C18 H34 O2 282.46
9-Octadecenoic acid, (Z)-;
Oleic acid
[112-80-1].DEFINITION
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. ]
IDENTIFICATION
IMPURITIES
SPECIFIC TESTS
• Specific Gravity 
841
:
0.889–0.895
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
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
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.
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.
ADDITIONAL REQUIREMENTS
• 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
11
USP Oleic Acid RS 
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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 1-301-816-8335 |
(EXC2010) Monographs - Excipients |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 1877
Pharmacopeial Forum: Volume No. 32(6) Page 1771