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Analysis of Glycerin According to Pharmaceutical Excipient Standards of Chinese Pharmacopoeia for “Glyceryl Tricaprylate” (Draft, Second Public Consultation) (KF-802)

According to the Chinese Pharmacopoeia draft for public consultation (Second Draft)* of the pharmaceutical excipient standard “Glyceryl Tricaprylate (Tricaprylin)”, content of free glycerin 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 300 mm (length), particle size: 5.0 µm), or columns with equivalent performance. In this application, glycerin analysis was performed using two GPC KF-802 columns, connected in series. 

*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
(Glycerin stadanrd solution) 0.25 mg/mL in THF

  1. 1.Glycerin
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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