The draft for public consultation of the Pharmaceutical Excipient Standards of the Chinese Pharmacopoeia* for sucrose palmitate specifies that, for the determination of sucrose palmitate content by size exclusion chromatography, two columns packed with a styrene–divinylbenzene copolymer (7.8 mm I.D. x 30 cm, particle size: 5 µm) connected in series, or columns with equivalent separation performance, are to be used. Two GPC KF-802 columns (8.0 mm I.D. x 30 cm, particle size: 6 µm) connected in series confirmed the system suitability requirements were met.
System suitability requirementsResolution between maltitol and sorbitol: ≥ 2
Resolution between the monoester and palmitic acid: ≥ 1.5
*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
15 mg/mL of Sucrose palmitate in THF
- 1.Triesters and polyesters
- 2.Diesters
- 3.Monoester
- 4.Palmitic acid

- Column
- :Shodex GPC KF-802 (8.0 mm I.D. x 300 mm) x 2
- Eluent
- :THF
- Flow rate
- :1.0 mL/min
- Detector
- :RI
- Column temp.
- :40 ℃
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 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)
- Analysis of Erythritol According to Pharmaceutical Excipient Standards of Chinese Pharmacopoeia (Draft, Public Consultation) (SH1011)
