Polyoxyl 35Castor Oil
»Polyoxyl 35Castor Oil contains mainly the tri-ricinoleate ester of ethoxylated glycerol,with smaller amounts of polyethylene glycol ricinoleate and the corresponding free glycols.It results from the reaction of glycerol ricinoleate with about 35moles 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 65
and 85and becomes clear on cooling to 40.
and 85and becomes clear on cooling to 40.
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.
C:
To a solution (1in 20)add bromine TS,dropwise:the bromine is decolorized.
Specific gravity á841ñ:
between 1.05and 1.06.
Viscosity á911ñ:
between 650and 850centipoises at 25,a capillary viscosimeter being used.
,a capillary viscosimeter being used.
Acid value á401ñ:
not more than 2.0.
Hydroxyl value á401ñ:
between 65and 80.
Iodine value á401ñ:
between 25and 35.
Saponification value á401ñ:
between 60and 75.
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
Pharmacopeial Forum:Volume No.30(5)Page 1668
Phone Number:1-301-816-8262