Printed on: Fri Jan 05 2024, [Link] PM(EST) Status: Currently Official on 06-Jan-2024 DocId: GUID-68BDA798-EB8A-400C-97CD-A1F359F9D805_5_en-US
Printed by: USP NF Official Date: Official as of 01-Jun-2023 Document Type: USP & NF @2024 USPC
Do Not Distribute DOI Ref: pqi5j DOI: [Link]
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rS = peak response from the Standard solution
Xylose CS = concentration of USP Xylose RS in the Standard
solution (mg/mL)
CU = concentration of Xylose in the Sample solution
(mg/mL)
Acceptance criteria: 98.0%–102.0% on the dried basis
PERFORMANCE TESTS
• COLOR OF SOLUTION
Sample: A freshly prepared 100 mg/mL solution
Acceptance criteria: The solution is clear and colorless.
C5H10O5 150.13 IMPURITIES
• RESIDUE ON IGNITION á281ñ: NMT 0.05%
D-Xylose;
D-Xylose [acyclic form] CAS RN®: 58-86-6.
D-Xylopyranose CAS RN®: 7261-26-9. Change to read:
α-D-Xylopyranose CAS RN®: 6763-34-4. • ▲IRON á241ñ, Procedures, Procedure 1▲ (CN 1-Jun-2023)
β-D-Xylopyranose CAS RN®: 2460-44-8. Test preparation: Dissolve 2.0 g in 45 mL of water, and add
DEFINITION 2 mL of hydrochloric acid.
Xylose contains NLT 98.0% and NMT 102.0% of xylose Acceptance criteria: NMT 5 µg/g
(C5H10O5), calculated on the dried basis. • ORGANIC IMPURITIES
al
Use the chromatogram of the Sample solution, obtained as
IDENTIFICATION directed in the Assay.
• A. SPECTROSCOPIC IDENTIFICATION TESTS á197ñ, Infrared Calculate the percentage of each individual impurity,
Spectroscopy: 197A excluding any solvent peaks, in the portion of Xylose
• B. The retention time of the major peak of the Sample taken:
solution corresponds to that of the Standard solution, as
obtained in the Assay.
ASSAY
• PROCEDURE
ci rU
Result = (r U/r T) × 100
= peak response of each individual impurity
rT = sum of all of the responses in the chromatogram
Mobile phase: Acetonitrile and water (75:25)
ffi
System suitability solution: 10 mg/mL of USP Xylose RS
Acceptance criteria
and 0.2 mg/mL of USP Fructose RS in Mobile phase
Individual impurities: NMT 1.0%
Standard solution: 10 mg/mL of USP Xylose RS in Mobile
Total impurities: NMT 2.0%
phase
Sample solution: 10 mg/mL of Xylose in Mobile phase SPECIFIC TESTS
Chromatographic system • OPTICAL ROTATION, Specific Rotation á781Sñ
O
(See Chromatography á621ñ, System Suitability.) Sample solution: 100 mg/mL in 0.012 N ammonium
Mode: LC hydroxide
Detector: UV 192 nm Acceptance criteria: +18.2° to +19.4°
Column: 4.6-mm × 15-cm; 5-µm packing L8 • LOSS ON DRYING á731ñ
Column temperature: 30° Sample: 2–5 g
Flow rate: 2 mL/min Analysis: Dry the Sample at a pressure not exceeding 50 mm
Injection volume: 25 µL of mercury at 60° to constant weight, a current of dried air
System suitability being passed through the oven during the drying period to
Sample: System suitability solution remove water vapor.
Suitability requirements Acceptance criteria: NMT 0.1%
Resolution: NLT 2.0 between the xylose and fructose
peaks ADDITIONAL REQUIREMENTS
Relative standard deviation: NMT 2.0% for xylose • PACKAGING AND STORAGE: Preserve in tight containers, and
Analysis store at controlled room temperature.
Samples: Standard solution and Sample solution • USP REFERENCE STANDARDS á11ñ
Calculate the quantity of xylose (C5H10O5) in the portion USP Fructose RS
of Xylose taken: USP Xylose RS
Result = (r U/r S) × (C S/C U) × 100
rU = peak response from the Sample solution
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