Confectioner's Sugar - Definition, Identification, Impurities - USP 2025

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

Confectioner's Sugar is Sucrose ground together with corn starch to a fine powder. It contains NLT 95.0% of sucrose (C12H22O11), calculated on the dried basis.

2 DENTIFICATION

A.

Sample solution: Transfer 20 g to a 100-mL volumetric flask, add 80 mL of water, shake to dissolve the sucrose, and then add water to volume. Separate the solubilized sucrose from the insoluble starch component by filtration until the filtrate is clear. Use the insoluble portion for the Identfication est, and use the freshly prepared, clear filtrate in the Impurities tests for Chloride and Sulfate (221), Chloride and Chloride and Sulfate (221), Sulfate and for Calcium, and in Spectic Tests for Oplical Rotation (781), Specific Rotation.

Analys: To the water slurry of the insoluble porton add lodine TS.

Acceptance crteria: A reddish-violet to deep blue color s produced.

B. It meets the requirements of the test for optcal Rotaton (781), Spectc Rotation in Specic Tests.

3 ASSAY

Conter Or Succose

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

System suitabllity soluton; Prepare an aqueous solution containing 20 mgimL 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 Confectioner's Sugar in water. Pass the solution through a 0.2-pm nylon syringe filter.

Chromatographic system

(See Chromatography (621), System Suitability.)

Mode: LC

Detector: Refractive index

Column: 4.6 mm × 15-cm, 5-m packing L8

Temperatures:

Column: 45°

Detector: 40°

Flow rate: 2.0 mL/min

Injection volume: 15 μL

System suitablity

Samples: System suitability solution and Standard solution

[Note—For relative retention times, see Table 1]

Suitabillty requirements
Resolution: NLT 1.3 between all adjacent peaks, System suitability solution
Relative standard deviation: NMT 2.0%, Standard solution

Analysis

Samples: Standard solution and Sample solution

Calculate, on the dried basis, the percentage of sucrose (C12H22O11) in the portion of Confectioner's Suger taken:

                    Result = (ru/rs) × (Cs/Cu) × 100

            ru  = peak response from the Sample solution  

            rs  = peak response from the Standard solution  

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

            Cu  = concentration of Confectioner’s Sugar in the Sample solution (mg/mL)

Acceptance criteria: NLT 95.0% of sucrose on the dried basis

4 IMPURITIES

Reswue on Ignlion (281): NMT 0.08%.

Ceuonce AND SULFATE, Chlorde (221)

Standard soluton: 0.40 mL of 0.020 N hydrochloric acid

Sample soluton: 10 mL of the clear filtrate from Identficaton test A

Acceptance crteria: 0.014%: the Sample solution shows no more chloride than the Standard solution.

CMEDE AND SUNATE, Sulfate (221)

Standard soluton: 0.30 mL of 0.020 N sulfuric acid.

Sample solution: 25 mL of the clear filtrate from Identficaton test A

Acceptance crteria: 0.006%: the Sample solution shows no more sulfate than the Standard solution.

CALCHM

Sample solubon: 5 mL of the clear filtrate from identfication test A

Analysis: To the Sample solution add 5 mL of water and 1 mL of ammonium oxalate TS.

Acceptance criteria: The Sample solution remains clear for NLT 1 min.

5 SPECIFIC TESTS

Mxeoawa. Ennssanon Test (61) and TENS ron Sreevic RCOMOORGAMS (52): The total aerobic microbial count does not exceed 10° cfulg, and the total combined molds and yeasts count does not exceed 10° cfu/g. It meets the requirements of the tests for absence of Salmonella species and Escherichia coll.

Loss en DyING (721)

Analysis: Dry at 105° for 4 h.

Acceptance criteria: NMT 1.0%.

Orncer. Roramon, Specte Rotaton (7815)

Sample soluton: Use the clear filtrate from Identfication test A.

Acceptance criteria: NLT +62.6° corresponding to NLT 95.0% of sucose (C12H22O11), calculated on the dried basis

ADDITIONAL REQUIREMENTS

PACKAGING AND STORAGE: Preserve in well-closed containers.

USP RErrewcE STANDARDS (11)

USP Arthydrous Lactose RS

USP Fructose RS

USP Dextrose RS

USP Maltose Monohydrate RS

USP Sucrose RS