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

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.

Note:: This analysis is performed at high temperature (80 ℃). The following is the procedure at the beginning and end of the analysis.
: (At the beginning of analysis) Set the initial flow rate at 0.2 to 0.3 mL/min and start the system. If the column is to be heated during the analysis, keep the low flow rate until the column temperature reaches to the set temperature, and then gradually increase the flow rate to the desired.
: (At the end of analysis) Reduce the flow rate to 0.2 ~ 0.3 mL/min, allow the column temperature to drop to room temperature, and then stop the pump.
: *Please read the operation manual carefully to achieve the best and consistent column performance for a long time.

System suitability requirements Scroll

	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)