Estimation method of endotoxin retention time and application thereof

The invention discloses an estimation method of endotoxin retention time and application thereof, and the method comprises the following steps: adding an endotoxin standard substance into a sample to be estimated to prepare a labeled sample, storing the labeled sample under different temperature conditions, and regularly detecting the recovery rate of endotoxin in the labeled sample so as to estimate the retention time of the endotoxin in the sample; wherein the endotoxin recovery rate R is larger than or equal to 50% and smaller than or equal to 200%. Compared with the prior art, the method has the following advantages: (1) the method for estimating the endotoxin retention time of the sample or biological stock solution in the production process is designed aiming at the condition of low recovery rate of the endotoxin in the biological medicine; (2) the method provided by the invention can provide guidance for the QC department to provide the maximum storage time of the sterile biological medicine, so that a