Linoleoyl 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

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. The article 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.

2 IDENTIFICATION

Change to read:

A. ^▲SPECTROSCOPIC IDENTIFICATION TESTS (197), Infrared Spectroscopy: 197F _{▲(CN 1-MAY-2020)}

B. THIN-LAYER CHROMATOGRAPHIC IDENTIFICATION TEST (201)

Standard solution: 50 mg/mL of USP Linoleoyl Polyoxylglycerides RS in methylene chloride

Sample solution: 50 mg/mL of Linoleoyl Polyoxylglycerides in methylene chloride

Application volume: 10 µL

Developing solvent system: Ether and hexanes (70:30)

Spray reagent: 0.1 mg/mL of rhodamine B in alcohol

Analysis

Samples: Standard solution and Sample solution

Acceptance criteria: The R_F 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)

NMT 0.1%

3.2 ALKALINE IMPURITIES

Sample: 5.0 g

Analysis: To the Sample 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.

Acceptance criteria: NMT 1.0 mL of 0.01 N hydrochloric acid is required.

3.3 LIMIT OF FREE ETHYLENE OXIDE AND DIOXANE

Analysis: Proceed as directed in Ethylene Oxide and Dioxane (228), Method 1.

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. Dilute with glacial acetic acid to 100.0 mL.

Potassium iodide solution: 75 mg/mL of potassium iodide

Blank: 25 mL of methylene chloride

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 0.1 M sodium thiosulfate VS. Perform a blank determination, and make any necessary correction.

Calculate the percentage of glycerol in the sample taken:

                  Result = {[(V_B - V_S) x N x F/W) x 100

V_B = Titrant volume consumed by the Blank (mL)

V_S = Titrant volume consumed by the Sample (mL)

N = actual normality of the Titrant (mEq/mL)

F = equivalency factor, 23.0 mg/mEq

W = Sample weight (mg)

Acceptance criteria: NMT 5.0%

4 SPECIFIC TESTS

4.1 FATS AND FIXED OILS, Acid Value (401)

Sample: 2.0 g

Acceptance criteria: NMT 2.0

4.2 FATS AND FIXED OILS, Fatty Acid Composition (401)

Linoleoyl Polyoxylglycerides exhibits the composition profile of fatty acids shown in Table 1.

Table 1  
 

4.3 FATS AND FIXED OILS, Hydroxyl Value (401)

Sample: 1.0 g

Acceptance criteria: 45-65

4.4 FATS AND FIXED OILS, Jodine Value (401)

90-110

4.5 FATS AND FIXED OILS, Peroxide Value (401)

Sample: 2.0 g

Acceptance criteria: NMT 12.0

4.6 FATS AND FIXED OILS, Saponification Value (401)

Sample: 2.0 g

Acceptance criteria: 150-170

4.7 WATER DETERMINATION, Method I (921)

Sample: 1.0 g

Analysis: Instead of using methanol as the solvent, one of two solvent systems can be used: a mixture of methylene chloride and anhydrous methanol (70:30 v/v), or anhydrous pyridine.

Acceptance criteria: NMT 1.0%

5 ADDITIONAL REQUIREMENTS

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 Linoleov! Polvoxvlalycerides RS