Ethyl oleate

• BPEthyl Oleate
• Ph. Eur.Ethyl Oleate
• USP–NFEthyl Oleate

Crodamol EO; ethyl (Z)-9-octadecenoate; ethylis oleas; oleic acid ethyl ester

(Z)-9-Octadecenoic acid ethyl ester · [111-62-6]

UNII Z2Z439864Y · PubChem CID 5363269

C20H38O2 · 310.51

Oleaginous vehicle

Typical concentrations: — · Dosage forms: Sterile (parenteral/ophthalmic)

Mainly used as a vehicle for intramuscular injections of lipophilic drugs such as steroid hormones, as an alternative to fixed oils; its lower viscosity makes injection easier and it is absorbed more rapidly by the tissues. It is also used as a solvent and penetration enhancer in topical and transdermal products, and as an oil phase in microemulsions and self-emulsifying systems.

A pale yellow to almost colourless, mobile, oily liquid. The pharmacopoeial material consists mainly of ethyl oleate together with ethyl esters of other fatty acids.

Relative density

about 0.866–0.874

Viscosity

about 4 mPa s at 25 °C, much lower than that of fixed oils

Iodine value

about 75–90

Acid value

not more than 0.5

Solubility

practically insoluble in water; miscible with chloroform, ethanol (95%), ether, fixed oils and liquid paraffin

Ethyl oleate oxidises on exposure to air, darkening and developing a rancid odour with a rise in peroxide value. Antioxidants such as propyl gallate, BHA, BHT or α-tocopherol are often added. Store in a well-filled, airtight, light-resistant container, preferably under nitrogen, in a cool place. It may be sterilised by dry heat or by filtration.

Dissolves certain types of rubber and causes others to swell, so closures and tubing must be chosen carefully. Incompatible with oxidising agents.

Prepared by esterification of oleic acid with ethanol, followed by purification.

Generally regarded as of low toxicity and only slightly irritant when used as an injection vehicle or topically. As with other oily vehicles, intramuscular injection may cause local reactions, and it must never be given intravenously.

Observe normal precautions for the quantity handled. Eye protection and gloves are recommended. It is combustible; keep away from sources of ignition.

Included in the FDA Inactive Ingredient Database (including intramuscular injections) and in parenteral and non-parenteral medicines licensed in Europe.

Isopropyl myristate; isopropyl palmitate; medium-chain triglycerides; oleic acid.

Because it is easily oxidised, the peroxide value of the material should be checked before use in injections, and oxygen should be excluded during manufacture and filling.