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Analysis of Xylitol According to USP-NF Method (SP0810)

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According to the United States Pharmacopeia and the National Formulary (USP 36-NF 31*), the assay of xylitol and analysis of related impurities (other polyols) should be carried out with a column with L34 packing material and meets the requirements summerized in below table. The SUGAR SP0810 confirmed the requirements were met.

*The version at the time of the application acquisition.

System Suitability Requirements:

Assay Impurities Analysis
Relative Retention Time Xylitol (1.0)
Galactitol (1.10)
L-Arabitol (0.76)
Mannitol (0.81)
Xylitol (1.0)
Galactitol (1.12)
Sorbitol (1.22)
Resolution ≥ 2.0 (Xylitol/Galactitol) ≥ 1.5 (Adjacent Polyols)
Relative Standard Deviation (RSD) ≤ 2%  (Xylitol) ≤ 5% (Galactitol)

Sample : 25 μL
1. Xylitol 25 mg/mL
2. Galactitol 2.5 mg/mL

Sample : 25 μL
1.L-Arabinitol 0.5 mg/mL
2. Mannitol 0.5 mg/mL
3. Xylitol 100 mg/mL
4. Galactitol 0.5 mg/mL
5. Sorbitol 0.5 mg/mL


 

Column       : Shodex SUGAR SP0810 (8.0 mm I.D. x 300 mm)
Eluent       : H2O/CH3CN=80/20
Flow rate    : 0.5 mL/min
Detector     : UV (192 nm)
Column temp. : 80 °C

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