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Polyoxyl 35 Castor Oil
» 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.
Identification—
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 650 and 850 centipoises at 25, a capillary viscosimeter 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%.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Auxiliary Information— Staff Liaison : Hong Wang, Ph.D. , Senior Scientific Associate
Expert Committee : (EM205) Excipient Monographs 2
USP29–NF24 Page 3402
Pharmacopeial Forum : Volume No. 30(5) Page 1668
Phone Number : 1-301-816-8351