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.Erythritol
- 2.Glycerol

Sample: 20 µL
- 1.Erythritol 0.02 mg/mL

- 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 ℃
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 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)
