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Category: Saccharides, Sugar Alcohols, Aminosugars and Amino Acids.

Analysis of Xylitol According to USP Method (SP0810)

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.

Note:
This analysis is performed at high temperature (80 ℃), and thus needs an attention. Please follow below procedures at the beginning and end of the analysis.
(At the beginning of analysis) Set the initial flow rate at 0.2 – 0.3 mL/min and start the system. Keep the low flow rate until the column temperature reaches to 80 ℃, 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:

ASSAY
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. Xylitol
  2. Galactitol

s1555b

 

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

s1555c

 

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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Category: Saccharides, Sugar Alcohols, Aminosugars and Amino Acids.