Former title:Linoleoyl Macrogolglycerides
» Linoleoyl Polyoxylglycerides is a mixture of monoesters, diesters, and triesters of glycerol and monoesters and diesters of polyethylene glycols. The polyethylene glycols used have a mean molecular weight between 300 and 400. It is produced by partial alcoholysis of unsaturated oils, mainly containing triglycerides of linoleic 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 the fatty acids of the unsaturated oils. It may contain free polyethylene glycols.
Packaging and storage Preserve in tight containers, protected from light and moisture. Store at controlled room temperature.
Labeling Label it to indicate the type and the average nominal molecular weight of polyethylene glycol used as part of the official title.
USP Reference standards 11
USP Linoleoyl Polyoxylglycerides RS
B: Thin-Layer Chromatographic Identification Test 201
Test solution: 50 mg per mL in methylene chloride.
Standard solution: 50 mg per mL of USP Linoleoyl Polyoxylglycerides RS in methylene chloride.
Application volume: 10 µL.
Developing solvent system: a mixture of ether and hexanes (7:3).
Spray reagent Prepare 0.1 mg per mL of solution of rhodamine B in alcohol.
Procedure Proceed as directed in the chapter. Then spray the plate with Spray reagent, and locate the spots on the plate by examination under UV light at a wavelength of 365 nm: the RF values of the principle spots obtained from the Test solution correspond to those obtained from the Standard solution.
C: It meets the requirements of the test for Fatty acid composition.
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 90 and 110.
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: Linoleoyl Polyoxylglycerides exhibits the following composition profile of fatty acids, as determined in the section Fatty Acid Composition under Fats and Fixed Oils 401:
Water, Method I 921: not more than 1.0%, determined on a 1.0-g specimen. Instead of using methanol as the solvent, two solvent systems can be used: a mixture of anhydrous methanol and methylene chloride (3:7 (v/v)) or anhydrous pyridine.
Total ash 561: not more than 0.1%.
Heavy metals, Method II 231: not more than 0.001%.
Alkaline impurities Weigh 5.0 g of Linoleoyl Polyoxylglycerides, add 10 mL of alcohol and 0.05 mL of bromophenol blue TS, and mix well. Titrate with 0.01 N hydrochloric acid VS to change the color to yellow: not more than 1.0 mL of 0.01 N hydrochloric acid is required.
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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USP35NF30 Page 1843Pharmacopeial Forum: Volume No. 34(4) Page 1015