• TOP
  • Applications
  • Analysis of Sucrose Palmitate According to Pharmaceutical Excipient Standards of Chinese Pharmacopoeia (Draft, Public Consultation) (KF-802)

Analysis of Sucrose Palmitate According to Pharmaceutical Excipient Standards of Chinese Pharmacopoeia (Draft, Public Consultation) (KF-802)

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. 1.Triesters and polyesters
  2. 2.Diesters
  3. 3.Monoester
  4. 4.Palmitic acid
Chromatogram of sucrose palmitate
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