Oleic Acid
C18H34O2 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.
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.
Specific gravity á841ñ: between 0.889and 0.895.
Congealing temperature á651ñ: between 3and 10for Oleic Acid derived from animal sources;between 10and 16for Oleic Acid derived from vegetable sources.
Acid value á401ñ: between 196and 204,about 2g,accurately weighed,being used.
Iodine value á401ñ: between 85and 95.
Residue on ignition á281ñ: not more than 1mg (about 0.01%),from a 10-mLportion.
Mineral acids— Shake 5mLwith an equal volume of water at a temperature of about 25for 2minutes,allow the liquids to separate,and filter the water layer through a paper filter previously moistened with water:the filtrate is not reddened by the addition of 1drop of methyl orange TS.
Neutral fat or mineral oil— Boil 1mLwith about 500mg of sodium carbonate and 30mLof water in a 250-mLflask:the resulting solution,while hot,is clear or,at most,opalescent.
Auxiliary Information— Staff Liaison:Catherine Sheehan,B.Sc.,Scientist
Expert Committee:(EMC)Excipients:Monograph Content
USP28–NF23Page 3043
Pharmacopeial Forum:Volume No.29(3)Page 701
Phone Number:1-301-816-8262