Establishment and verification of a detecting method for residual chloroform amount in freeze-dried live attenuated hepatitis A vaccine
Song Tianyang, Zhao Wangli, Luo Zhenghui, Tang Jun, Wang Xuan, Yang Huan, Yang Dongqiong, Qiao Yan, Song Jie
Abstract
ObjectiveTo establish an accurate and reliable method to determinate residual chloroform amount in freeze-dried live attenuated hepatitis A vaccine.
MethodsThe content of chloroform was measured by headspace gas chromatography and calculated by external standard method. The specificity, linearity and range, accuracy, precision, detection limit, quantitative limit and durability of the analytical method were verified.
ResultsThe relative standard deviation (RSD) value of chloroform peak was less than 5% and the degree of separation from other peaks was greater than 1.5. The peak of chloroform in the positive solution was observed during the corresponding retention time, and there was no chloroform peak observed in the reference solution. The concentration of chloroform in the range of 10-1 000 ng/ml was linearly related to the peak area. The solution recovery rates of the tested samples were between 91.3% and 99.0% with the concentrations of 600 ng/ml, and the RSDs were all less than 4%. The quantitative limit concentration was 0.022 ng/ml.
ConclusionThe established method has good specificity, linearity and range, accuracy, precision and durability, and accord with requirements of quantitative measurement.
Key words:
Chloroform; Chromatography, gas; Hepatitis A vaccine; Vaccines, attenuated; Method verification
Contributor Information
Song Tianyang
Department of Quality Control, Institute of Medical Biology, Chinese Academy of Medical Sciences, Key Laboratory for Quality Control and Evaluation of Vaccines and Biological Products, National Medical Products Administration, Kunming 650018, China
Zhao Wangli
Department of Quality Control, Institute of Medical Biology, Chinese Academy of Medical Sciences, Key Laboratory for Quality Control and Evaluation of Vaccines and Biological Products, National Medical Products Administration, Kunming 650018, China
Luo Zhenghui
Department of Quality Control, Institute of Medical Biology, Chinese Academy of Medical Sciences, Key Laboratory for Quality Control and Evaluation of Vaccines and Biological Products, National Medical Products Administration, Kunming 650018, China
Tang Jun
Department of Quality Control, Institute of Medical Biology, Chinese Academy of Medical Sciences, Key Laboratory for Quality Control and Evaluation of Vaccines and Biological Products, National Medical Products Administration, Kunming 650018, China
Wang Xuan
Department of Quality Control, Institute of Medical Biology, Chinese Academy of Medical Sciences, Key Laboratory for Quality Control and Evaluation of Vaccines and Biological Products, National Medical Products Administration, Kunming 650018, China
Yang Huan
Department of Quality Control, Institute of Medical Biology, Chinese Academy of Medical Sciences, Key Laboratory for Quality Control and Evaluation of Vaccines and Biological Products, National Medical Products Administration, Kunming 650018, China
Yang Dongqiong
Department of Quality Control, Institute of Medical Biology, Chinese Academy of Medical Sciences, Key Laboratory for Quality Control and Evaluation of Vaccines and Biological Products, National Medical Products Administration, Kunming 650018, China
Qiao Yan
Department of Quality Control, Institute of Medical Biology, Chinese Academy of Medical Sciences, Key Laboratory for Quality Control and Evaluation of Vaccines and Biological Products, National Medical Products Administration, Kunming 650018, China
Song Jie
Department of Quality Control, Institute of Medical Biology, Chinese Academy of Medical Sciences, Key Laboratory for Quality Control and Evaluation of Vaccines and Biological Products, National Medical Products Administration, Kunming 650018, China
