Sucrose Palmitate

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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C₂₈H₅₂O₁₂ 580.71

C₄₄H₈₂O₁₃ 819.11

C₆₀H₁₁₂O₁₄ 1057.52

Sucrose monopalmitate;

Sucrose hexadecanoate CAS RN®: 26446-38-8.

1 DEFINITION

Sucrose Palmitate is a mixture of sucrose monoesters, mainly sucrose monopalmitate, obtained by transesterification of palmitic acid methyl esters of vegetable origin with sucrose. The manufacture of the fatty acid methyl esters includes a distillation step. It contains variable quantities of mono- and diesters as set forth in the following table:

2 IDENTIFICATION

A. It meets the requirements of the Fatty Acid Composition test.

B. It meets the requirements of the Content of Monesters, Diesters, Triesters, and Polyesters.

3 ASSAY

3.1 Content of Monoesters, Diesters, Triesters, and Polyesters

Mobile phase: Tetrahydrofuran

Sample solution: 15 mg/mL of Sucrose Palmitate in tetrahydrofuran

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC, size-exclusion

Detector: Differential refractometer

Column: 7-mm × 60-cm; packing L21, 100 Å

[Note - Two 7-mm × 30-cm L21 columns may be used in place of one 60-cm column, provided system suitability requirements are met.]

Flow rate: 1.2 mL/min

Injection size: 20 μL

Analysis

Sample: Sample solution

[Note - The relative retention time with reference to the monoester peak (retention time is approximately 10 min) is about 0.92 for diesters, and about 0.90 for triesters and polyesters.]

[Note - Disregard solvent peaks and peaks having a signal-to-noise ratio less than 10.]

Calculate the percentage of monoesters in the portion of Sucrose Palmitate taken:

Result = A × (100 − D − S − E)/100

A = percentage of monoesters determined by peak normalization

D = percentage of free fatty acids, using the following formula:

Result = AV × 256/561.1

AV = acid value

S = percentage of free sucrose (see Free Sucrose in Organic Impurities)

E = percentage of water (see Water Determination, Ia in Specific Tests)

Calculate the percentage of diesters in the portion of Sucrose Palmitate taken:

Result = B × (100 − D − S − E)/100

B = percentage of diesters determined by peak normalization

D = percentage of free fatty acids (above)

S = percentage of free sucrose (see Free Sucrose in Organic Impurities)

E = percentage of water (see Water Determination, Ia in Specific Tests)

Calculate the percentage of triesters and polyesters in the portion of Sucrose Palmitate taken:

Result = C × (100 − D − S − E)/100

C = percentage of triesters and polyesters determined by peak normalization

D = percentage of free fatty acids (above)

S = percentage of free sucrose (see Free Sucrose in Organic Impurities)

E = percentage of water (see Water Determination, Ia in Specific Tests)

3.2 Fatty Acid Composition

Sucrose Palmitate exhibits the following composition profiles of fatty acids, as determined under Fats and Fixed Oils, Fatty Acid Composition 〈401〉.

4 IMPURITIES

Change to read:

Inorganic Impurities

Fats and Fixed Oils, Acid Value 〈401〉: NMT 6.0 (ERR 1-May-2020) , determined on a 3-g sample. Use a freshly neutralized mixture of 2-propanol and water (2:1), and gently heat.

Organic Impurities

Procedure: Free Sucrose

Solution A: 10 μg/mL of ammonium acetate in acetonitrile

Solution B: 10 μg/mL of ammonium acetate in tetrahydrofuran and water (90:10)

Diluent: Tetrahydrofuran and water (87.5:12.5)

System suitability solution: 500 μg/mL of USP Sucrose RS in Diluent

Standard solutions: 0.50, 1.0, 2.0, and 2.5 mg/mL of USP Sucrose RS in Diluent

Sample solution: 50 mg/mL of Sucrose Palmitate in Diluent

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: Evaporative light-scattering. [Note—If the detector has different setting parameters, adjust the detector settings so that they comply with the System suitability requirements.]

Carrier gas: Nitrogen

Detector temperature: 45°

Nebulizer temperature: 40°

Column: 4.6-mm × 0.25-m; packing L8

Injection size: 20 μL

Mobile phase and flow rate: See the gradient table below.

System suitability

Sample: System suitability solution

[Note - The retention time is about 26 min for sucrose palmitate.]

Suitability requirements

Signal-to-noise ratio: 10:1

Analysis

Samples: Standard solutions and Sample solution

Prepare a standard curve by plotting the peak response versus concentration of sucrose in the Standard solutions. Calculate the amount of free sucrose in the Sucrose Palmitate taken.

Acceptance criteria: NMT 4.0%

5 SPECIFIC TESTS

Water Determination, Method Ia 〈921〉: NMT 4.0% on a 0.20-g sample

Total Ash

Sample: 1.0 g

Analysis: Heat a silica or platinum crucible to redness for 30 min, allow to cool in a desiccator, and weigh. Transfer the Sample into the crucible. Dry at 100°–105° for 1 h and ignite to constant weight in a mufle furnace at 600 ± 25°, allowing the crucible to cool in a desiccator after each ignition. Flames should not be produced at any time during the procedure. If after prolonged ignition the ash still contains black particles, add hot water, filter through an ashless filter paper, and ignite the residue and the filter paper. Combine the filtrate with the ash, carefully evaporate to dryness and ignite to constant weight.

Acceptance criteria: NMT 1.5%

6 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in a well-closed container. Protect from humidity and avoid high temperatures.

USP Reference Standards 〈11〉

USP Sucrose RS