Study on detection of bacterial endotoxin by micro kinetic chromogenic method
- VernacularTitle:微量动态显色法细菌内毒素检查方法研究
- Author:
Chen-Xue ZHANG
1
;
Tong CAI
;
Chen CHEN
;
Xiao-Yan ZHAO
;
Yu-Sheng PEI
Author Information
- Keywords: bacterial endotoxin; methodological validation; va-riety suitability; consistency comparison; micro kinetic chromo-genic assay; complementary alternative methods
- From: Chinese Pharmacological Bulletin 2024;40(7):1392-1398
- CountryChina
- Language:Chinese
- Abstract: Aim To determine whether the micro kinetic chro-mogenic method can meet the requirements of Chinese Pharma-copoeia,as a supplement to the existing bacterial endotoxin test method.Methods Using micro kinetic chromogenic horseshoe crab reagent,the sample volume per well was 25 μL,the detec-tion wavelength was 405 nm,the preset OD value was 0.05,and the detection was carried out by half-well enzyme plate.In accordance with the provisions of"9101 Guiding Principles for Validation of Drug Quality Analysis Methods"in the fourth part of the 2020 edition of the People's Republic of China Pharmaco-poeia,the methodological verification of 7 items of specificity,accuracy,precision,limit of quantification,linearity,range and durability was carried out according to the specific requirements of the"quantitative"item in the"Determination of Impurities".The variety suitability study was conducted on 74 batches of samples from 48 drug varieties,and 143 batches of samples from 76 drug varieties(including 133 batches of negative samples and 10 batches of positive samples)were tested daily,and the re-sults were compared with the results of traditional color rendering method.Results The method of microdynamic color develop-ment met the requirements of the Pharmacopoeia of the People's Republic of China for quantitative methods.The results of varie-tal applicability and consistency comparison showed that the mi-crodynamic color development method had better equivalence compared with the traditional color development method.Con-clusion The micro kinetic chromogenic method can be promo-ted as a supplementary alternative to the existing bacterial endo-toxin methods.
