Analysis of Sucrose Stearate According to Chinese Pharmacopoeia 2025 Edition (KF-802)
According to the Chinese Pharmacopoeia 2025 Edition*, Part IV, “Sucrose Stearate,” the content is determined by size exclusion chromatography (SEC). The method specifies the use of two columns** packed with styrene divinylbenzene copolymer (7.8 mm (I.D.) x 30 cm (L), particle size: 5 µm), or columns with equivalent performance. Two Shodex GPC KF-802 columns (8.0 mm (I.D.) x 30 cm (L), particle size: 6 µm) connected in series, confirmed the system suitability requirements were met.

System suitability requirementsResolution between diester and monoester: ≥ 1.2
Resolution between monoester and stearic 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 stearate (contains 70 % monostearate) in THF

1. 1.Sucrose tristearate and polyesters
2. 2.Sucrose distearate
3. 3.Sucrose stearate
4. 4.Stearic acid