Polyoxyl 35 Castor Oil
(pol'' ee ox' il kas' tor oyl).
» Polyoxyl 35 Castor 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 35 moles of ethylene oxide.
Packaging and storage— Preserve in tight containers.
USP Reference standards 11
USP Polyoxyl 35 Castor Oil RS
B: Dissolve about 0.1 g in 10 mL of alcoholic potassium hydroxide TS, boil for about 3 minutes, and evaporate to dryness. Mix the residue with 5 mL of water: it dissolves, yielding a clear solution. Add a few drops of glacial acetic acid: a white precipitate is formed.
C: To a solution (1 in 20) add bromine TS, dropwise: the bromine is decolorized.
Specific gravity 841: between 1.05 and 1.06.
Viscosity 911: between 600 and 850 centipoises at 25, a capillary viscometer being used.
Acid value 401: not more than 2.0.
Hydroxyl value 401: between 65 and 80.
Iodine value 401: between 25 and 35.
Saponification value 401: between 60 and 75.
Water, Method I 921: not more than 3.0%.
Residue on ignition 281: not more than 0.3%.
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Topic/Question Contact Expert Committee
Monograph Robert H. Lafaver, M.S.
Scientific Liaison
(EXC2010) Monographs - Excipients
Reference Standards RS Technical Services
USP35–NF30 Page 1916
Pharmacopeial Forum: Volume No. 31(6) Page 1671