Analysis of Ethylcellulose Dispersion Type B According to USP-NF Method (KF-802)

According to the United States Pharmacopeia and the National Formulary (USP 43-NF 38*), "ASSAY" and "OTHER COMPONENTS: Content of Medium-Chain Triglycerides" for "Ethylcellulose Dispersion Type B" should be carried out with a column filled with L21 packing material. The GPC KF-802, a column filled with L21 packing material, confirmed the requirements were met.

System suitability requirements ASSAY
Relative standard deviation (RSD) of Ethylcellulose peak (Standard solution): ≤ 5.0%
Tailing factor of Ethylcellulose peak (Standard solution): ≤ 2.0

Content of Medium-Chain Triglycerides
Relative standard deviation (RSD) of Medium-chain triglycerides peak (Standard solution): ≤ 5.0%
Resolution between Ethylcellulose and Medium-chain triglycerides (Standard solution): ≥ 2.0

*The version at the time of the application acquisition.

Sample: 20 µL
(Standard solution for Content of Medium-Chain Triglycerides) Ethylcellulose 3.75 mg/mL, Medium-chain triglycerides 0.6 mg/mL and Oleic acid 0.4 mg/mL in THF

  1. 1.Ethylcellulose
  2. 2.Medium-chain triglycerides
  3. 3.Oleic acid
Column
Shodex GPC KF-802 (8.0 mm I.D. x 300 mm)
Eluent
THF
Flow rate
0.5 mL/min
Detector
RI (45 ℃)
Column temp.
45 ℃

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