Polyoxyl Oleate

Polyethylene glycol monooleate [9004-96-0].
»Polyoxyl Oleate is a mixture of the monoesters and diesters of oleic acid and mixed polyethylene glycols.It may be obtained by ethoxylation of oleic acid or by esterification of polyethylene glycols with oleic acid of animal or vegetable origin.It may contain free polyethylene glycol.The average polymer length is equivalent to either 5–6or 10oxyethylene units (nominal values).Asuitable antioxidant may be added.
Packaging and storage— Preserve in tight containers,and store in a cool,dry place.Protect from moisture.
Labeling— Label it to indicate the number of ethylene oxide units per molecule (nominal value),and the name and concentration of any added antioxidant.
USP Reference standards á11ñ— USP Polyoxyl Oleate RS.
Identification, Infrared Absorption á197Fñ,on undried specimen.
Acid value á401ñ: not more than 1.0,determined on 10.0g.
Hydroxyl value á401ñ— See table below.
Iodine value á401ñ— See table below.
Peroxide value á401ñ: not more than 12.0.
Saponification value á401ñ— See table below.
5–6Ethylene
Oxide Units		 10Ethylene
Oxide Units
Hydroxyl value 50–70 65–90
Iodine value 50–60 27–34
Saponification
value		 105–120 68–85
Fatty acid composition á401ñ— Polyoxyl Oleate exhibits the following composition profile of fatty acids,as determined in the USPgeneral chapter sectionFatty Acid Composition:
Carbon-Chain Length No.of Double Bonds Percentage (%)
14 0 £5.0
16 0 £16.0
18 0 £6.0
16 1 £8.0
18 1 65.0–88.0
18 2 £18.0
18 3 £4.0
>18 — £4.0
Alkalinity— Dissolve 2.0g of Polyoxyl Oleate in 20mLof alcohol.To 2mLof this solution,add 0.05mLof phenol red TS:the solution is not red.
Total ash á561ñ: not more than 0.3%,determined on 1.0g.
Water,Method Iá921ñ: not more than 2.0%.
Limit of free ethylene oxide and dioxane— Proceed as directed forLimit of free ethylene oxide and dioxane underPolyoxyl Stearyl Ether:not more than 1µg per g of free ethylene oxide is found;and not more than 10µg per g of dioxane is found.
Auxiliary Information— Staff Liaison:Elena Gonikberg,Ph.D.,Scientist
Expert Committee:(EMC)Excipients:Monograph Content
USP28–NF23Page 3061
Pharmacopeial Forum:Volume No.29(4)Page 1121
Phone Number:1-301-816-8251