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Analysis of Sugars and Sugar Alcohols in Human Blood Products According to Chinese Pharmacopoeia 2025 Edition (SH1011)

The Chinese Pharmacopoeia 2025 Edition*, Part IV “Human Blood Products,” the high‑performance liquid chromatography method for the determination of sugars and sugar alcohols specifies the use of a column packed with a styrene–divinylbenzene copolymer–based cation‑exchange resin (hydrogen form) with dimensions of 7.8 mm (I.D.) x 300 mm (L) and a particle size of 9 or 8 µm**. SUGAR SH1011 column confirmed the requirements were met.

System suitability requirements

Resolution between the maltose peak and the sulfosalicylic acid peak: > 1.5
Tailing factor of maltose: 0.95–1.50
Correlation coefficient of linear regression (R2): ≥ 0.999

*The version at the time of the application acquisition.
**Chinese Pharmacopoeia 2025 edition allows changes in column dimensions, packing material, and particle sizes. 

Sample: 20 µL

  1. 1.Sulfosalicylic acid 7.5 mg/mL
  2. 2.Maltose 10 mg/mL

Sample: 20 µL

  1. 2.Maltose 30 mg/mL
  2. 3.Glucose 15 mg/mL
  3. 4.Sorbitol 15 mg/mL

Sample: 20 µL

  1. 5.Sucrose 30 mg/mL

***Since sucrose partially decomposes when analyzed at or above 25 ℃, the calibration curve should be constructed using the peak area including the decomposition products.

Column
Shodex SUGAR SH1011 (8.0 mm I.D. x 100 mm)
Eluent
4 mM H2SO4 aq.
Flow rate
0.8 mL/min
Detector
RI (35 ℃)
Column temp.
(A), (B); 50 ℃ (C); 25 ℃

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