The Chinese Pharmacopoeia 2025 Edition*, Part IV, the monograph for Polydextrose, the determination of glucose, sorbitol, and 1,6‑anhydro‑β‑D‑glucose by high‑performance liquid chromatography specifies the use of a column packed with strong cation exchange resin (calcium form) in which sulfonic acid groups are bonded to a cross linked styrene divinylbenzene copolymer (7.8 mm (I.D.) x 300 mm (length), particle size: 10 µm). SUGAR SC1011 column confirmed the requirements were met.
System suitability requirements
Elution order: Glucose, 1,6‑anhydro‑β‑D‑glucose, Sorbitol
Resolution between each of glucose, 1,6‑anhydro‑β‑D‑glucose, and sorbitol: ≥ 1.0
Relative standard deviation (RSD): ≤ 5.0%
*The version at the time of the application acquisition.
Sample: 20 µL
- 1.Glucose 0.16 mg/mL
- 2.1,6-Anhydro-D-Glucose 0.08 mg/mL
- 3.Sorbitol 0.08 mg/mL

- Column
- :Shodex SUGAR SC1011 (8.0 mm I.D. x 300 mm)
- Eluent
- :H2O
- Flow rate
- :0.6 mL/min
- Detector
- :RI (35 ℃)
- Column temp.
- :80 ℃
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 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 Sugars and Sugar Alcohols in Human Blood Products According to Chinese Pharmacopoeia 2025 Edition (SH1011)
- 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)
