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Oleoyl Polyoxylglycerides
(Title for this new monograph—to become official April 1, 2010)
(Prior to April 1, 2010, it is expected that the current practice of labeling the article of commerce with the name Oleoyl Macrogolglycerides will be continued.)
» Oleoyl Polyoxylglycerides are mixtures of monoesters, diesters, and triesters of glycerol and monoesters and diesters of polyethylene glycols with a mean relative molecular weight between 300 and 400. They are produced by partial alcoholysis of unsaturated oils, mainly containing triglycerides of oleic acid, with polyethylene glycol, by esterification of glycerol and polyethylene glycol with fatty acids, or as a mixture of glycerol esters and ethylene oxide condensate with fatty acids of the unsaturated oils. The average molecular weight is not less than 90.0 percent and not more than 110.0 percent of the labeled nominal value.
Packaging and storage— Preserve in tight containers, protected from light and moisture. Store at controlled room temperature.
Labeling— Label it to indicate the average nominal molecular weight of esters as part of the official title.
Identification—
A: Infrared Absorption 197F.
B: It meets the requirements for Identification test B under Caprylocaproyl Polyoxylglycerides.
Acid value 401: not more than 2.0, determined on a 2.0-g specimen.
Hydroxyl value 401: between 45 and 65, determined on a 1.0-g specimen, accurately weighed.
Iodine value 401: between 75 and 95.
Peroxide value 401: not more than 12.0, determined on a 2.0-g specimen.
Saponification value 401: between 150 and 170, determined on a 2.0-g specimen.
Fatty acid composition 401: between 4.0% and 9.0% of palmitic acid is found; not more than 6.0% of stearic acid is found; not more than 2.0% each of linolenic acid, arachidic acid, and eicosenoic acid is found; between 58.0% and 80.0% of oleic acid is found; and between 15.0% and 35.0% of linoleic acid is found.
Water, Method I 921: not more than 1.0%, determined on a 1.0-g specimen.
Total ash 561: not more than 0.1%, determined on a 1.0-g specimen.
Limit of free ethylene oxide and dioxane— Proceed as directed in the test for Limit of free ethylene oxide and dioxane under Caprylocaproyl Polyoxylglycerides: not more than 1 µg of ethylene oxide per g is found; and not more than 10 µg of dioxane per g is found.
Limit of free glycerol— Proceed as directed in the test for Limit of free glycerol under Caprylocaproyl Polyoxylglycerides: not more than 5.0% is found.
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 3382
Pharmacopeial Forum : Volume No. 30(4) Page 1330
Phone Number : 1-301-816-8351