Polyoxyl 40Hydrogenated Castor Oil
»Polyoxyl 40Hydrogenated Castor Oil contains mainly the tri-hydroxystearate ester of ethoxylated glycerol,with smaller amounts of polyethylene glycol tri-hydroxystearate and of the corresponding free glycols.It results from the reaction of glycerol tri-hydroxystearate with about 40to 45moles of ethylene oxide.
Packaging and storage—
Preserve in tight containers.
Identification—
A:
Dissolve about 0.1g in 1mLof water,add 9mLof sodium chloride solution (1in 20),and heat in a water bath:the solution becomes turbid at a temperature between 70
and 85.
and 85.
B:
Dissolve about 0.1g in 10mLof alcoholic potassium hydroxide TS,boil for about 3minutes,and evaporate to dryness.Mix the residue with 5mLof water:it dissolves,yielding a clear solution.Add a few drops of glacial acetic acid:a white precipitate is formed.
Acid value á401ñ:
not more than 2.0.
Hydroxyl value á401ñ:
between 60and 80.
Iodine value á401ñ:
not more than 2.0.
Saponification value á401ñ:
between 45and 69.
Water,Method Iá921ñ:
not more than 3.0%.
Residue on ignition á281ñ:
not more than 0.3%.
Heavy metals,Method IIá231ñ:
0.001%.
Organic volatile impurities,Method Iá467ñ:
meets the requirements.
Auxiliary Information—
Staff Liaison:Catherine Sheehan,B.Sc.,Scientist
Expert Committee:(EMC)Excipients:Monograph Content
USP28–NF23Page 3060
Phone Number:1-301-816-8262