Xylose

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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C₅H₁₀O₅         150.13

D-Xylose;

D-Xylose [acyclic form] CAS RN: 58-86-6.

D-Xylopyranose CAS RN: 7261-26-9.

α-d-Xylopyranose CAS RN: 6763-34-4.

β-d-Xylopyranose CAS RN: 2460-44-8.

1 DEFINITION

Xylose contains NLT 98.0% and NMT 102.0% of xylose (C₅H₁₀O₅), calculated on the dried basis.

2 IDENTIFICATION

A. Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197A

B. The retention time of the major 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 (75:25)

System suitability solution: 10 mg/mL of USP Xylose RS and 0.2 mg/mL of USP Fructose RS in Mobile phase

Standard solution: 10 mg/mL of USP Xylose RS in Mobile phase

Sample solution: 10 mg/mL of Xylose in Mobile phase

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 192 nm

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

Column temperature: 30°

Flow rate: 2 mL/min

Injection volume: 25 µL

System suitability

Sample: System suitability solution

Suitability requirements

Resolution: NLT 2.0 between the xylose and fructose peaks

Relative standard deviation: NMT 2.0% for xylose

Analysis

Samples: Standard solution and Sample solution

Calculate the quantity of xylose (C₅H₁₀O₅) in the portion of Xylose 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 Xylose RS in the Standard solution (mg/mL)

C_u = concentration of Xylose in the Sample solution (mg/mL)

Acceptance criteria: 98.0%–102.0% on the dried basis

4 PERFORMANCE TESTS

Color of Solution

Sample: A freshly prepared 100 mg/mL solution

Acceptance criteria: The solution is clear and colorless.

5 IMPURITIES

Residue on Ignition 〈281〉: NMT 0.05%

Change to read:

Iron 〈241〉, Procedures, Procedure 1 _{(CN 1-Jun-2023)}

Test preparation: Dissolve 2.0 g in 45 mL of water, and add 2 mL of hydrochloric acid.

Acceptance criteria: NMT 5 µg/g

Organic Impurities

Use the chromatogram of the Sample solution, obtained as directed in the Assay.

Calculate the percentage of each individual impurity, excluding any solvent peaks, in the portion of Xylose taken:

Result = (r_u /r_T ) × 100

r_u = peak response of each individual impurity

r_T = sum of all of the responses in the chromatogram

Acceptance criteria

Individual impurities: NMT 1.0%

Total impurities: NMT 2.0%

6 SPECIFIC TESTS

Optical Rotation, Specific Rotation 〈781S〉

Sample solution: 100 mg/mL in 0.012 N ammonium hydroxide

Acceptance criteria: +18.2° to +19.4°

Loss on Drying 〈731〉

Sample: 2–5 g

Analysis: Dry the Sample at a pressure not exceeding 50 mm of mercury at 60° to constant weight, a current of dried air being passed through the oven during the drying period to remove water vapor.

Acceptance criteria: NMT 0.1%

7 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in tight containers, and store at controlled room temperature.

USP Reference Standards 〈11〉

USP Fructose RS

USP Xylose RS