Polyoxyl Lauryl Ether

Polyethylene glycol monolauryl ether [9002-92-0].
»Polyoxyl Lauryl Ether is a mixture of the mono-lauryl ethers of mixed polyethylene glycols,the average polymer length being equivalent to not less than 3and not more than 23oxyethylene units (nominal value).It contains various amounts of free lauryl alcohol,and it may contain some free polyethylene glycols.
Packaging and storage— Preserve in tight containers,and store in a cool,dry place.
Labeling— Label it to indicate the average nominal number of oxyethylene units.
USP Reference standards á11ñ— USP Polyoxyl Lauryl Ether RS.
Appearance of solution— Dissolve 5.0g of Polyoxyl Lauryl Ether in 50.0mLof alcohol,and proceed as directed for Appearance of solution under Polyoxyl Stearyl Ether.
Identification—
A: Infrared Absorption á197Fñ—Use a thin film of melted test specimen if the material is a solid.
B: Dissolve or disperse 0.1g in 5mLof alcohol,add 10mLof diluted hydrochloric acid,5mLof barium chloride TS,and 10mLof phosphomolybdic acid solution (1in 10):a precipitate is formed.
Acid value á401ñ: not more than 1.0,determined on 5.0g.
Hydroxyl value á401ñ: within the ranges specified in the accompanying table.
Oxyethylene Units per
Molecule (Nominal Value)		 Hydroxyl Value
3 165–185
4 145–165
5 130–140
9 90–100
10 85–95
12 73–83
15 64–74
20–23 40–60
Iodine value á401ñ: not more than 2.0.
Saponification value á401ñ: not more than 3.0,determined on 10.0g.
Alkalinity— Dissolve 2.0g of Polyoxyl Lauryl Ether in a hot mixture of 10mLof alcohol and 10mLof water.Add 0.05mLof bromothymol blue TS,and titrate with 0.1Nhydrochloric acid to a yellow endpoint:not more than 0.5mLof 0.1Nhydrochloric acid is required.
Water,Method Iá921ñ: not more than 3.0%.
Total ash á561ñ: not more than 0.2%,determined on 2.0g.
Limit of free ethylene oxide and dioxane— Proceed as directed for Limit of free ethylene oxide and dioxaneunder Polyoxyl 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 1117
Phone Number:1-301-816-8251