Sugar Spheres

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

Sugar Spheres contain NLT 62.5% and NMT 91.5% of sucrose (C₁₂H₂₂O₁₁), calculated on the dried basis, the remainder consisting chiey of corn (NF 1-May-2023) starch. They consist of approximately spherical particles of a labeled nominal size range. They may contain color additives permitted by the FDA for use in drugs.

2 IDENTIFICATION

A.

Sample suspension: 1:10

Analysis: Add iodine TS to the Sample suspension.

Acceptance criteria: A violet to deep blue color is produced.

B. It meets the requirements of the test for Optical Rotation 〈781S〉, Procedures, Specic Rotation in Specic Tests.

3 ASSAY

Content of Sucrose

Mobile phase: Acetonitrile and water (80:20, v/v)

System suitability solution: Prepare an aqueous solution containing 20 mg/mL of sucrose, 1.0 mg/mL of dextrose (Glucose), 0.6 mg/mL of fructose, 0.6 mg/mL of maltose, and 0.8 mg/mL of lactose using USP Sucrose RS, USP Dextrose RS, USP Fructose RS, USP Maltose Monohydrate RS, and USP Anhydrous Lactose RS.

Standard solution: Dissolve USP Sucrose RS in water to obtain a solution having a concentration of about 20 mg/mL of sucrose.

Sample solution: 20 mg/mL of Sugar Spheres in water. Pass the solution through a 0.2-µm nylon syringe lter.

3.1 Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: Refractive index

Column: 4.6-mm × 15-cm; 5-µm packing L8

Temperatures

Column: 45°

Detector: 40°

Flow rate: 2.0 mL/min

Injection volume: 15 µL

3.2 System suitability

Samples: System suitability solution and Standard solution

[Note—See Table 1.]

Table 1

Suitability requirements

Resolution: NLT 1.3 between all adjacent peaks, System suitability solution

Relative standard deviation: NMT 2.0%, Standard solution

3.3 Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of sucrose in the portion of Sugar Spheres taken:

Result = (r_U /r_S ) × (C_S /C_U ) × 100

r_U = peak response from the Sample solution

r_S = peak response from the Standard solution

C_S = concentration of USP Sucrose RS in the Standard solution (mg/mL)

C_U = concentration of Sugar Spheres in the Sample solution (mg/mL)

Acceptance criteria: 62.5%–91.5% on the dried basis

4 IMPURITIES

Residue on Ignition 〈281〉

Sample: 2.0 g

Analysis: Ignite at a temperature of 700 ± 25°.

Acceptance criteria: NMT 0.25%

5 SPECIFIC TESTS

Microbial Enumeration Tests 〈61〉 and Tests for Specified Microorganisms 〈62〉: The total aerobic microbial count does not exceed 102 cfu/g, and the Sugar Spheres meet the requirements of the tests for absence of Salmonella species, Escherichia coli, Staphylococcus aureus, and Pseudomonas aeruginosa.

Optical Rotation 〈781S〉, Procedures, Specific Rotation

Sample solution: Transfer 20 g to a 200-mL volumetric flask, add 160 mL of water, shake to dissolve the sucrose, add water to volume, and mix. Pass the solubilized sucrose solution by vacuum filtration through fine filter paper.

Acceptance criteria: +41° to +61°, corresponding to 62.5%–91.5% of sucrose (C₁₂H₂₂O₁₁ ), calculated on the dried basis 

Loss on Drying 〈731〉

Analysis: Dry at 105° for 4 h.

Acceptance criteria: NMT 4.0%

Particle Size Distribution Estimation by Analytical Sieving 〈786〉: NLT 90% of it passes the coarser sieve size stated in the labeling; all of it passes the next coarser sieve size listed in Table 1 of the chapter; and NMT 10% passes the finer sieve size stated in the labeling.

6 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in well-closed containers.

Labeling: The label states the nominal particle size range. Label it to indicate the name and amount of any added color additives.

USP Reference Standards 〈11〉

USP Anhydrous Lactose RS

USP Dextrose RS

USP Fructose RS

USP Maltose Monohydrate RS

USP Sucrose RS