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

Sample: 20 µL
- 2.Maltose 30 mg/mL
- 3.Glucose 15 mg/mL
- 4.Sorbitol 15 mg/mL

Sample: 20 µL
- 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 ℃
Sample Name Index
Operation Manual / Certificate of Analysis
Operation Manuals and Certificate of Analysis / Inspection Certificate for the following products can be downloaded here.
Product Name Index
Applications
- Analysis of Lactose According to Chinese Pharmacopoeia 2025 Edition (VG-50 4E)
- Analysis of Sucrose Stearate According to Chinese Pharmacopoeia 2025 Edition (KF-802)
- Analysis of Sucrose Palmitate According to Pharmaceutical Excipient Standards of Chinese Pharmacopoeia (Draft, Public Consultation) (KF-802)
- Analysis of Glycerin According to Pharmaceutical Excipient Standards of Chinese Pharmacopoeia for “Glyceryl Tricaprylate” (Draft, Second Public Consultation) (KF-802)
- Analysis of Mannitol in According to Chinese Pharmacopoeia 2025 Edition Standard (SC1011)
- Analysis of Lactitol Monohydrate According to Pharmaceutical Excipient Standards of Chinese Pharmacopoeia (Draft, Public Consultation) (SC1011)
- Analysis of Glucose, Sorbitol, and 1,6‑Anhydro‑β‑D‑Glucose in Polydextrose According to Chinese Pharmacopoeia 2025 Edition (SC1011)
- Analysis of Maltitol According to Chinese Pharmacopoeia 2025 Edition (SC1011)
- Analysis of Dextran 20 and Dextran 40 According to Chinese Pharmacopoeia 2025 Edition (SB‑803 HQ)
- Analysis of Four Saccharides in Honey According to Chinese Pharmacopoeia 2025 Edition (NH2P‑50 4E)
- Analysis of Citrate Ion According to Chinese Pharmacopoeia 2025 Edition (SH1011)
- Analysis of Trehalose According to Chinese Pharmacopoeia 2025 Edition (KS-801)
- Analysis of Human Serum Albumin Multimers According to Chinese Pharmacopoeia 2025 Edition (KW-803)
- Analysis of IgG Monomers and Dimers in Human Immunoglobulin Preparations According to Chinese Pharmacopoeia 2025 Edition (KW-803)
- Analysis of Erythritol According to Pharmaceutical Excipient Standards of Chinese Pharmacopoeia (Draft, Public Consultation) (SH1011)
