C18H34O2 282.46
9-Octadecenoic acid, (Z)-.
Oleic acid [112-80-1].

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 841: between 0.889 and 0.895.

Congealing temperature 651: between 3 and 10 for Oleic Acid derived from animal sources; between 10 and 16 for Oleic Acid derived from vegetable sources.

Acid value 401: between 196 and 204, about 2 g, accurately weighed, being used.

Iodine value 401: between 85 and 95.

Residue on ignition 281: not more than 1 mg (about 0.01%), from a 10-mL portion.

Mineral acids— Shake 5 mL with an equal volume of water at a temperature of about 25 for 2 minutes, 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 1 drop of methyl orange TS.

Neutral fat or mineral oil— Boil 1 mL with about 500 mg of sodium carbonate and 30 mL of water in a 250-mL flask: the resulting solution, while hot, is clear or, at most, opalescent.

Organic volatile impurities, Method IV 467: meets the requirements.

Residual solvents 467: meets the requirements.

Expert Committee : (EM105) Excipient Monographs 1

USP29–NF24 Page 3382

Phone Number : 1-301-816-8262