Behenoyl Polyoxylglycerides
» Behenoyl 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 of 400. It is produced by esterification of glycerol and polyethylene glycols with behenic acid.
Packaging and storage— Preserve in tight, light-resistant containers, protected from heat and moisture. Store at a temperature not higher than 35.
Labeling— Label it to indicate the average nominal molecular weight of polyethylene glycols used as part of the official title.
USP Reference standards 11
USP Behenoyl 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 Behenoyl 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 4.0, determined on a 2.0-g specimen.
Hydroxyl value 401: between 30 and 50, determined on a 1.0-g test specimen, accurately weighed. [note—If the volume of 0.5 N sodium hydroxide VS required for the titration is less than 2 mL, a more dilute titrant may be used. ]
Peroxide value 401: not more than 6.0, determined on a 2.0-g specimen.
Saponification value 401: between 120 and 140, determined on a 2.0-g specimen.
Fatty acid composition 401 Behenoyl Polyoxylglycerides exhibits the following composition profile of fatty acids, as determined in the section Fatty Acid Composition under Fats and Fixed Oils 401:
Carbon-chain length No. of double bonds Percentage
12 0 1.0
14 0 1.0
16 0 3.0
18 0 5.0
20 0 10.0
22 0 83.0
22 1 3.0
24 0 3.0
Water, Method I 921: not more than 1.0%, determined on a 1.0-g specimen, anhydrous pyridine being used as the solvent.
Total ash 561: not more than 0.1%, determined on a 2.0-g specimen.
Heavy metals, Method II 231: not more than 0.001%.
Alkaline impurities— Weigh 5.0 g of Behenoyl Polyoxylglycerides, heat slightly until the substance melts, add 10 mL of alcohol and 0.05 mL of bromophenol blue TS, and mix well. While the solution is still warm, 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 3.0% is found.
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Monograph Robert H. Lafaver, M.S.
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(EXC2010) Monographs - Excipients
Reference Standards RS Technical Services
USP35–NF30 Page 1705
Pharmacopeial Forum: Volume No. 34(5) Page 1217