Analysis of Sucrose Stearate According to USP-NF Method (KF-802)

Sucrose stearate is a nonionic surfactant widely used not only as an emulsifier in cosmetics but also in pharmaceutical and food applications. According to the United States Pharmacopeia and the National Formulary (USPNF 2026 Issue 2*), "Assay: Content of Monoesters, Diesters, Triesters, and Polyesters" for "Sucrose Stearate" should be carried out with a column (column size: 7 mm I.D. x 60 cm) or two columns in series (column size: 7 mm I.D. x 30 cm) filled with L21 packing material. Two GPC KF-802 columns (8.0 mm I.D. x 30 cm/column) filled with L21 packing material, connected in series achieved a good separation of diester, monoester, and stearic acid.

*The version at the time of the application acquisition.

Sample: 20 µL
(Sample solution) 15 mg/mL of Sucrose stearate (contains 70 % monostearate) in THF

  1. 1.Triesters and polyesters
  2. 2.Diesters
  3. 3.Monoesters
  4. 4.Stearic acid
Chormatogram of Sucrose stearate
Column
Shodex GPC KF-802 (8.0 mm I.D. x 300 mm) x 2
Eluent
THF
Flow rate
1.2 mL/min
Detector
RI
Column temp.
25 ℃

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