Xylitol

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

Xylitol contains NLT 98.5% and NMT 101.0% of C₅H₁₂O₅, calculated on the anhydrous basis.

2 IDENTIFICATION

Change to read:

A. ▲Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197K▲ (CN 1-May-2020)

Sample: Undried

B. The retention time of the xylitol peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.

3 ASSAY

Procedure

Mobile phase: Acetonitrile and water (20:80)

System suitability solution: 2.5 mg/mL of USP Galactitol RS and 25 mg/mL of USP Xylitol RS in Mobile phase

Standard solution: 25 mg/mL of USP Xylitol RS in Mobile phase

Sample solution: 25 mg/mL of Xylitol in Mobile phase

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 192 nm

Column: 8.0-mm × 30-cm; 7-µm packing L34

Column temperature: 80°

Flow rate: 0.5 mL/min

Injection size: 25 µL

System suitability

Sample: System suitability solution and Standard solution

[Note—The relative retention times for xylitol and galactitol are about 1.0 and 1.10, respectively.]

Suitability requirements

Resolution: NLT 2.0 between galactitol and xylitol, System suitability solution

Relative standard deviation: NMT 2.0%, Standard solution

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of xylitol (C₅H₁₂O₅) in the portion of sample taken:

Result = (rᵤ/rₛ) × (Cₛ/Cᵤ) × 100

rᵤ = peak response of xylitol from the Sample solution

rₛ = peak response of xylitol from the Standard solution

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

Cᵤ = concentration of the Sample solution (mg/mL)

Acceptance criteria: 98.5%–101.0% on the anhydrous basis

4 IMPURITIES

Residue on Ignition 〈281〉: NMT 0.5%

Reducing Sugars

Sample: 500 mg

Analysis: Dissolve the Sample in 2.0 mL of water in a 10-mL conical flask. Into a similar flask, pipet 2 mL of a 0.5 mg/mL dextrose solution.

To each flask add 1 mL of alkaline cupric tartrate TS, heat to boiling, and cool.

Acceptance criteria: Any turbidity in the xylitol flask is NMT that in the dextrose flask, in which a reddish-brown precipitate forms (0.2% reducing sugars, as dextrose).

Limit of Other Polyols

Mobile phase: Acetonitrile and water (20:80)

System suitability solution: 0.5 mg/mL each of USP L-Arabinitol RS, USP Galactitol RS, USP Mannitol RS, and USP Sorbitol RS, and 100 mg/mL of USP Xylitol RS in Mobile phase

Standard solution: 0.5 mg/mL each of USP L-Arabinitol RS, USP Galactitol RS, USP Mannitol RS, and USP Sorbitol RS in Mobile phase

Sample solution: 100 mg/mL of Xylitol in Mobile phase

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 192 nm

Column: 8.0-mm × 30-cm; 7-µm packing L34

Column temperature: 80°

Flow rate: 0.5 mL/min

Injection size: 25 µL

System suitability

Samples: System suitability solution and Standard solution

[Note—The relative retention times for L-arabinitol, mannitol, xylitol, galactitol, and sorbitol are about 0.76, 0.81, 1.0, 1.12, and 1.22, respectively.]

Suitability requirements

Resolution: NLT 1.5 between all adjacent polyol peaks, System suitability solution

Relative standard deviation: NMT 5.0% for the galactitol peak, Standard solution

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of each polyol (L-arabinitol, galactitol, mannitol, or sorbitol) in the portion of sample taken:

Result = (rᵤ/rₛ) × (Cₛ/Cᵤ) × 100

rᵤ = peak response of the individual polyol from the Sample solution

rₛ = peak response of the individual polyol from the Standard solution

Cₛ = concentration of the individual polyol in the Standard solution (mg/mL)

Cᵤ = concentration of the Sample solution (mg/mL)

Acceptance criteria: The sum of the polyols is NMT 2.0%, calculated on the anhydrous basis.

5 SPECIFIC TESTS

Water Determination, Method I 〈921〉: NMT 0.5%

6 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in well-closed containers.

USP Reference Standards 〈11〉

USP L-Arabinitol RS

USP Galactitol RS

USP Mannitol RS

USP Sorbitol RS

USP Xylitol RS