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

Glyceryl stearate 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*), the assay for glyceryl stearate (glyceryl monostearate) is carried out with a column (one column size: 7.5 mm ID and 60 cm length) filled with L21 packing material and meets following requirement. The use of two GPC KF-802 columns connected in series (one column size: 8.0 mm ID and 30 cm length, i.e., total of 60 cm length) confirmed the requirement was met.

 

System suitability requirement Relative standard deviation of monoglyceride peak area: ≤ 2.0


*The version at the time of the application acquisition.

Sample: 40 μL
(Sample solution) 8 mg/mL Glyceryl Monostearate in THF

  1.  
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
Column temp.
40 ℃

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