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Analysis of Erythritol According to Pharmaceutical Excipient Standards of Chinese Pharmacopoeia (Draft, Public Consultation) (SH1011)

The draft for public consultation of the Pharmaceutical Excipient Standards of the Chinese Pharmacopoeia for Erythritol by high‑performance liquid chromatography specifies the use of a column packed with strong cation exchange resin (hydrogen form) in which sulfonic acid groups are bonded to a cross linked styrene divinylbenzene copolymer or a column with equivalent separation performance. SUGAR SH1011 column confirmed the requirements were met.

System suitability requirement

Resolution between the 50 mg/mL erythritol peak and the 50 mg/mL glycerol peak: ≥ 2.0
Sensitivity test requirement;
Signal‑to‑noise ratio (S/N) of erythritol (0.02 mg/mL, 20 µL injection): > 10

*The version at the time of the application acquisition.

Sample: 20 µL
50 mg/mL each

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

Sample: 20 µL

  1. 1.Erythritol 0.02 mg/mL
Chromatogfram of 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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