Investigation of bacterial endotoxin detection method for raw materials and injections of paliperidone palmitate
10.19778/j.chp.2025.04.018
- VernacularTitle:棕榈酸帕利哌酮原料药及其注射液细菌内毒素检查方法研究
- Author:
Shulan ZHU
1
;
Na ZHAO
;
Yani SHI
;
Yutong JIANG
;
Lili JIN
;
Yonggang DU
Author Information
1. 浙江华海药业股份有限公司杭州分公司,杭州 310018
- Publication Type:Journal Article
- Keywords:
paliperidone palmitate;
injections of paliperidone palmitate;
bacterial endotoxin;
chromogenic sub-strate method;
interference experiment;
bacterial endotoxin recovery
- From:
Drug Standards of China
2025;26(4):444-448
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To establish the method of bacterial endotoxin detection for raw materials and injections of paliperidone palmitate.Methods:Paliperidone palmitate was dissolved with tetrahydrofuran and polysorbate 20 as solvent,and then diluted with BET H2O.According to bacterial endotoxin test in Chinese Pharmacopoeia 2020 Vol general charpters 1143,methodology validation of chromogenic substrate method in bacterial endotoxin test was con-ducted and then the interference experiment of solubilizer was added.Results:Paliperidone palmitate did not pre-cipitate during the experimental process,and then diluted to 0.007 mg·mL-1 with BET H2O.There was no inter-ference for chromogenic substrate method,while the bacterial endotoxin recovery of the solubilizer does not interfere with endotoxin testing.Conclusion:The method established in this paper is suitable for bacteria endotoxin test of raw materials and injections of paliperidone palmitate.
