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Printed by: Le Tran Official Date: Official as of 01-May-2021 Document Type: NF @2021 USPC
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Proceed as directed in the chapter, then spray the plate with

Lauroyl Polyoxylglycerides Spray reagent, and locate the spots on the plate by
To view the Notice from the Expert Committee that posted in examination under UV light at a wavelength of 365 nm.
conjunction with this accelerated revision, please click Acceptance criteria: The RF values of the principal spots of
https://www.uspnf.com/ the Sample solution correspond to those of the Standard
rb-lauroyl-polyoxylglycerides-notice-20210430. solution.
• C. It meets the requirements in Specific Tests (see Table 1)
for Fats and Fixed Oils á 401ñ , Procedures, Fatty Acid
Composition.
• D. It meets the requirements in Specific Tests for Fats and
Fixed Oils á 401ñ , Procedures, Saponification Value for Lauroyl
Polyoxylglycerides 600 only.
IMPURITIES
• ARTICLES OF BOTANICAL ORIGIN á 561ñ , Methods of Analysis,
Total Ash: NMT 0.1%
• ALKALINE IMPURITIES
Sample: 5.0 g
Analysis: Heat the Sample slightly until the test 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.

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Acceptance criteria: NMT 1.0 mL of 0.01 N hydrochloric
Lauroyl Polyoxylglycerides 300 [12737-91-6]. acid is required.
Lauroyl Polyoxylglycerides 600 [137802-73-4]. • LIMIT OF FREE ETHYLENE OXIDE AND DIOXANE
Lauroyl Polyoxylglycerides 1500 [121548-04-7]. Analysis: Proceed as directed in Ethylene Oxide and Dioxane
DEFINITION á 228ñ , Method I.
Lauroyl Polyoxylglycerides is a mixture of monoesters, diesters,
and triesters of glycerol and monoesters and diesters of
polyethylene glycols. The polyethylene glycols used have a
ci Acceptance criteria
Ethylene oxide: NMT 1 µg/g
Dioxane: NMT 10 µg/g
mean molecular weight between 300 and 1500. The article • LIMIT OF FREE GLYCEROL
is produced by partial alcoholysis of saturated oils, mainly Sample: 1.2 g
ffi
containing triglycerides of lauric acid with polyethylene Periodic acetic acid solution: Dissolve 0.446 g of sodium
glycols, by esterification of glycerol and polyethylene periodate in 2.5 mL of a 25% (v/v) solution of sulfuric acid,
glycols with fatty acids, or as a mixture of glycerol esters diluting to 100.0 mL with glacial acetic acid.
and ethylene oxide condensate with the fatty acids of the Potassium iodide solution: 75 mg/mL of potassium iodide
hydrogenated oils. It may contain free polyethylene glycols. Blank: 25 mL of methylene chloride
Titrimetric system
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IDENTIFICATION (See Titrimetry á 541ñ .)

• A. SPECTROSCOPIC IDENTIFICATION TESTS á 197ñ , Infrared Mode: Residual titration
Spectroscopy: 197A. This test only applies to Lauroyl Titrant: 0.1 M sodium thiosulfate VS
Polyoxylglycerides 300 and Lauroyl Polyoxylglycerides Endpoint detection: Visual
1500. Use USP Lauroyl Polyoxylglycerides 300 RS for the Analysis: Dissolve the Sample in 25 mL of methylene
Lauroyl Polyoxylglycerides 300 sample. Use USP Lauroyl chloride, heating if necessary. Cool, and add 100 mL of
Polyoxylglycerides 1500 RS for the Lauroyl water and 25.0 mL of Periodic acetic acid solution. Shake,
Polyoxylglycerides 1500 sample. For Lauroyl and allow to stand for 30 min. Add 40 mL of Potassium
Polyoxylglycerides 300, 197F can also be used with the iodide solution, and allow to stand for 1 min. Add 1 mL of
following standard/sample preparation details: the starch TS, and titrate the liberated iodine with 0.1 M
standard or sample is melted at 70° first and is suspended sodium thiosulfate VS. Perform a blank determination, and
neat between suitable plates. make any necessary correction.
For Lauroyl Polyoxylglycerides 1500, 197K can also be used. Calculate the percentage of glycerol in the sample taken:

Change to read: Result = {[(VB − VS) × N × F]/W} × 100

• B. THIN-LAYER CHROMATOGRAPHIC IDENTIFICATION TEST á VB = Titrant volume consumed by the Blank (mL)
201ñ : For Lauroyl Polyoxylglycerides 300 and Lauroyl VS = Titrant volume consumed by the Sample (mL)
Polyoxylglycerides 1500 only N = actual normality of the Titrant (mEq/mL)
Standard solution: 50 mg/mL of USP Lauroyl F = equivalency factor, 23.0 mg/mEq
Polyoxylglycerides 300 RS (for Lauroyl Polyoxylglycerides W = Sample weight (mg)
300 sample) or ▲USP Lauroyl Polyoxylglycerides
1500 RS▲ (RB 1-May-2021) (for Lauroyl Polyoxylglycerides 1500 Acceptance criteria: NMT 5.0%
sample) in methylene chloride
Sample solution: 50 mg/mL of Lauroyl Polyoxylglycerides SPECIFIC TESTS
in methylene chloride • FATS AND FIXED OILS á 401ñ , Procedures, Acid Value
Application volume: 10 µL Sample: 2.0 g
Developing solvent system: Ether and hexanes (70:30) Acceptance criteria: NMT 2.0
Spray reagent: 0.1 mg/mL of rhodamine B in alcohol • FATS AND FIXED OILS á 401ñ , Procedures, Fatty Acid
Analysis Composition: Lauroyl Polyoxylglycerides exhibits the
Samples: Standard solution and Sample solution composition profile of fatty acids shown in Table 1.

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Table 1 • FATS AND FIXED OILS á 401ñ , Procedures, Saponification Value

Carbon-Chain Number of Percentage Sample: 2.0 g
Length Double Bonds (%) Acceptance criteria: Within the range specified in Table 3
8 0 ≤15.0
for the labeled type

10 0 ≤12.0 Table 3
12 0 30.0–50.0 Type of Saponification
Polyethylene Glycols Value
14 0 5.0–25.0
300 190–204
16 0 4.0–25.0
600 150–170
18 0 5.0–35.0
1500 79–93

• FATS AND FIXED OILS á 401ñ , Procedures, Hydroxyl Value

Sample: 1.0 g • WATER DETERMINATION á 921ñ , Method I
Acceptance criteria: Within the range specified in Table 2 Sample: 1.0 g
for the labeled type Analysis: Instead of using methanol as the solvent, one of
two solvent systems can be used: a mixture of methylene
Table 2 chloride and anhydrous methanol (70:30 v/v), or
anhydrous pyridine.
Type of Hydroxyl
Polyethylene Glycols Value
Acceptance criteria: NMT 1.0%
300 65–85 ADDITIONAL REQUIREMENTS

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• PACKAGING AND STORAGE: Preserve in tight containers,
600 50–70 protected from light and moisture. Store at controlled room
1500 36–56 temperature.
• LABELING: Label it to indicate the type and the average
nominal molecular weight of polyethylene glycols used as
• FATS AND FIXED OILS á 401ñ , Procedures, Iodine Value: NMT
2.0
• FATS AND FIXED OILS á 401ñ , Procedures, Peroxide Value
Sample: 2.0 g
ci part of the official title.
• USP REFERENCE STANDARDS á 11ñ
USP Lauroyl Polyoxylglycerides 300 RS
USP Lauroyl Polyoxylglycerides 1500 RS
Acceptance criteria: NMT 6.0
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