According to the United States Pharmacopeia and the National Formulary (USP 43-NF 38*), analysis ethylcellulose in “Ethylcellulose Dispersion Type B” should be carried out with a column filled with L75 packing material and meets following requirements. The GPC KF-802 confirmed the requirements were met.
System suitability requirements:
Resolution of ethylcellulose and medium-chain triglyceride: ≥ 2.0
Tailing factor of ethylcellulose: ≤ 2.0
Relative standard deviation (RSD) : ≤ 5.0%
*The version at the time of the application acquisition.
Sample : 20 μL
Standard solution
1. Ethylcellulose 3750 mg/L
2. Medium-chain triglyceride 600 mg/L
3. Oleic acid 400 mg/L
Column : Shodex GPC KF-802 (8.0 mm I.D. x 300 mm) Eluent : THF Flow rate : 0.5 mL/min Detector : RI Column temp. : 45 °C
