(Title for this new monographto become official January 1, 2011)
(Prior to January 1, 2011, the current practice of labeling the article of commerce with the name Lauroyl Macrogolglycerides may be continued.)
» Lauroyl 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 1500. They are produced by partial alcoholysis of saturated oils, mainly containing triglycerides of lauric acid with polyethylene glycols, by esterification of glycerol and polyethylene glycols with fatty acids, or as a mixture of glycerol esters and ethylene oxide condensate with the fatty acids of the hydrogenated 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. The label also indicates the nominal saponification value.
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 36 and 85, determined on a 1.0-g specimen, accurately weighed.
Iodine value 401: not more than 2.0.
Peroxide value 401: not more than 6.0, determined on a 2.0-g specimen.
Saponification value 401: between 79 and 204, determined on a 2.0-g specimen.
Fatty acid composition 401: not more than 15.0% of caprylic acid is found; not more than 12.0% of capric acid is found; between 30% and 50% of lauric acid is found; between 5% and 25% of myristic acid is found; between 4% and 25% of palmitic acid is found; and between 5% and 35% of stearic 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.
Heavy metals, Method II 231: 0.001%.
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.
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USP32NF27 Page 1265Pharmacopeial Forum: Volume No. 34(5) Page 1224