According to the United States Pharmacopeia and the National Formulary (USP 36-NF 31*), ”ASSAY" and "IMPURITIES: Limit of Other Polyols" for "Xylitol" should be carried out with a column filled with L34 packing material. The SUGAR SP0810, a column filled with L34 packing material, confirmed the requirements were met.

System suitability requirementsASSAY
Relative retention time: xylitol (1.0), Galactitol (1.10)
Resolution between galactitol and xylitol (System suitability solution): ≥ 2.0
Relative standard deviation (RSD) (Standard solution)≤ 2.0%

IMPURITIES: Limit of Other Polyols
Relative retention time:  L-alabitol (0.76), mannitol (0.81), xylitol (1.0), galactitol (1.12), sorbitol (1.22)
Resolution between all adjacent polyol peaks (System suitability solution): ≥ 1.5
Relative standard deviation (RSD) of galactitol (Standard solution): ≤ 5.0%

*The version at the time of the application acquisition.

Sample: 25 µL
(System suitability solution for ASSAY) 2.5 mg/mL of Galactitol and 25 mg/mL of Xylitol in eluent

1. 1.Xylitol
2. 2.Galactitol

Sample: 25 µL
(System suitability solution for IMPURITIES) 0.5 mg/mL each of L-Arabinitol, Galactitol, Mannitol, and Sorbitol, and 100 mg/mL of Xylitol in eluent

1. 1.L-Arabinitol
2. 2.Mannitol
3. 3.Xylitol
4. 4.Galactitol
5. 5.Sorbitol