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 summarized in the 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
