Behenoyl Polyoxylglycerides

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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1 DEFINITION

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.

2 IDENTIFICATION

A. SPECTROSCOPIC IDENTIFICATION TESTS 〈197〉 , Infrared Spectroscopy : 197K

B. THIN-LAYER CHROMATOGRAPHIC IDENTIFICATION TEST 〈201〉

• Standard solution: 50 mg/mL of USP Behenoyl Poly oxylgl y cerides RS in methylene chloride Sample solution: 50 mg/mL of Behenoyl Polyoxylglycerides in methylene chloride Chromatographic system
• Application volume: 10 µL
• Developing solvent system: Ether and hexanes (70:30)
• Spray reagent: 0.1-mg/mL solution of rhodamine B in alcohol
• Analysis: 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.
• Acceptance criteria: The R values of the principal spots of the Sample solution correspond to those of the Standard solution.

C. It meets the requirements in Specific Tests (see Table 1) for Fats and Fixed Oils, Fatty Acid Composition 〈401〉.

3 IMPURITIES

3.1 ARTICLES OF BOTANICAL ORIGIN, Total Ash 〈561〉

Sample solution: 2.0 g Acceptance criteria: NMT 0.1%

3.2 ALKALINE IMPURITIES

Sample: 5.0 g

Analysis: Heat the Sample slightly until it 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.

Acceptance criteria: NMT 1.0 mL of 0.01 N hydrochloric acid

3.3 LIMIT OF FREE ETHYLENE OXIDE AND DIOXANE

Analysis: Proceed as directed in Ethylene Oxide and Dioxane 〈228〉, Method I. Acceptance criteria

Ethylene oxide: NMT 1 µg/g Dioxane: NMT 10 µg/g

3.4 LIMIT OF FREE GLYCEROL

Sample: 1.2 g

Periodic acetic acid solution: Dissolve 0.446 g of sodium periodate in 2.5 mL of a 25% (v/v) solution of sulfuric acid, and dilute with glacial acetic acid to 100.0 mL.

Potassium iodide solution: 75 mg/mL of potassium iodide Titrimetric system

(See Titrimetry 〈541〉.) Mode: Residual titration

Titrant: 0.1 M sodium thiosulfate VS Endpoint detection: Visual

Analysis: Dissolve the Sample in 25 mL of methylene chloride, heating if necessary. Cool, and add 100 mL of water and 25.0 mL of Periodic acetic acid solution. Shake, and allow to stand for 30 min. Add 40 mL of Potassium iodide solution, and allow to stand for 1 min. Add 1 mL of starch TS, and titrate the liberated iodine with Titrant. Perform a blank determination, and make any necessary correction. Each mL of Titrant is equivalent to 2.3 mg of Glycerin.

Acceptance criteria: NMT 3.0%

4 SPECIFIC TESTS

4.1 FATS AND FIXED OILS, Acid Value 〈401〉

Sample: 2.0 g

Acceptance criteria: NMT 4.0

4.2 FATS AND FIXED OILS, Fatty Acid Composition 〈401〉: Behenoyl Polyoxylglycerides exhibits the composition profile of fatty acids in Table 1.

Table 1

Change to read:

4.3 FATS AND FIXED OILS, Hydroxyl Value 〈401〉

Sample: 1.0 g

Analysis: Proceed as directed in the chapter. If the volume of ▲0.5 N alcoholic potassium hy droxide VS▲ (ERR 1-Mar-2022) required for the titration is less than 2 mL, a more dilute titrant may be used.

Acceptance criteria: 30–50

4.4 FATS AND FIXED OILS, Peroxide Value 〈401〉

Sample: 2.0 g

Acceptance criteria: NMT 6.0

4.5 FATS AND FIXED OILS, Saponification Value 〈401〉

Sample: 2.0 g

Acceptance criteria: 120–140

4.6 WATER DETERMINATION, Method I 〈921〉

Sample: 1.0 g

Analysis: Use anhydrous pyridine as the solvent. Acceptance criteria: NMT 1.0%

5 ADDITIONAL REQUIREMENTS

• PACKAGING AND STORAGE: Preserve in tight, light-resistant containers, protected from heat and moisture. Store at NMT 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