Analysis of Erythritol in According to USP-NF Method (SH1011)

According to the United States Pharmacopeia and the National Formulary (USP-NF 2024 Issue 3*), the assay of erythritol, should be carried out with a column packed with L17 packing material and meets following requirements. The SUGAR SH1011, an ion exclusion chromatography column, confirmed the requirements were met.

System suitability requirements

Resolution (0.05-mg/mL each USP Erythritol RS and glycerol): ≥ 2.0
Relative standard deviation (RSD) for 50-mg/mL USP Erythritol RS: ≤ 2.0%

*The version at the time of the application acquisition.

Sample: 10 µL
(System suitability solution) 0.05 mg/mL of each in H2O

  1. 1.USP Erythritol RS
  2. 2.Glycerol
Chromatogfram of USP Erythiritol

Sample: 10 µL
(Standard solution) 50 mg/mL USP Erythritol RS in H2O

  1. 1.USP Erythritol RS
Chromatogfram of USP Erythiritol
Column
Shodex SUGAR SH1011 (8.0 mm I.D. x 300 mm)
Eluent
0.01 % H2SO4 aq.
Flow rate
0.8 mL/min
Detector
RI
Column temp.
70 ℃

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