Analysis of Glyceryl Tristearate According to USP-NF Method (KF-802)

Glyceryl tristearate is a type of emulsifier and is widely used mainly in pharmaceuticals and cosmetics. According to the United States Pharmacopeia and the National Formulary (USP 43-NF 38*), "ASSAY" for "Glyceryl Tristearate" should be carried out with a 7.5 mm (I.D.) x 60 cm (length) column filled with L21 packing material. Use of two GPC KF-802 columns, 8.0 mm (I.D.) x 30 cm (length) each, filled with L21 packing material in series confirmed the requirements were met.

System suitability requirementsResolution between monoglycerides and disterearates peaks (System suitability solution): ≥ 1.0
Relative standard deviation of monoglycerides peak (System suitability solution): ≤ 2.0%

*The version at the time of the application acquisition.

Sample: 40 µL
(Sample solution) 8 mg/mL Glyceryl Tristearate in THF
(System suitability solution) 40 mg/mL Glyceryl Distearate in THF

  1. 1.Triglycerides
  2. 2.Diglycerides
  3. 3.Monoglycerides
  4. 4.Glycerin
Chromatogram of glyceryl monostearate
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 (40 ℃)
Column temp.
40 ℃

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