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Polyoxyl 40 Hydrogenated Castor Oil
» Polyoxyl 40 Hydrogenated 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 40 to 45 moles of ethylene oxide.
Packaging and storage— Preserve in tight containers.
Identification—
A: Dissolve about 0.1 g in 1 mL of water, add 9 mL of sodium chloride solution (1 in 20), and heat in a water bath: the solution becomes turbid at a temperature between 70 and 85.
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.
Congealing temperature 651: between 16 and 26.
Acid value 401: not more than 2.0.
Hydroxyl value 401: between 60 and 80.
Iodine value 401: not more than 2.0.
Saponification value 401: between 45 and 69.
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
Phone Number : 1-301-816-8351