Quality Evaluation of Cisatracurium Besilate Injection
10.3870/j.issn.1004-0781.2025.01.004
- VernacularTitle:苯磺顺阿曲库铵注射剂的质量评价
- Author:
Jing FANG
1
;
Xinying YU
;
Kai DUO
;
Biwei BAI
;
Yu HAN
;
Kexin XIAO
;
Xinying MA
;
Liqun LIU
;
Jialiang ZHU
Author Information
1. 黑龙江省药品检验研究院化药检验研究所,国家药品监督管理局中药质量研究与评价重点实验室,黑龙江省中药质量研究与评价重点实验室,哈尔滨 150088
- Publication Type:Journal Article
- Keywords:
Cisatracurium besilate injection;
Quality evaluation;
Related substance;
1,5-Pentanediol diacrylate;
Residual solvents
- From:
Herald of Medicine
2025;44(1):31-38
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the quality of cisatracurium besilate injection produced by domestic manufacturers.Methods A comprehensive evaluation of 104 batches of samples was carried out using statutory testing methods combined withexploratory research,including related substances,1,5-pentanediol diacrylate,residual solvents,genotoxic impurities of benzenesulfonate esters,infrared spectrum,and endotoxin examination.The quality of domestic products and the controllability of current specifications were comprehensively evaluated.Results According to the statutory tests,the qualified rate of 104 batches of samples was 100.0％.The exploratory research showed that the results of related substances in the samples produced by 6 manufacturers were far below the limit,and no genotoxic impurities of benzenesulfonate esters were detected.However,the results showed that there was variability in 1,5-pentanediol diacrylate,as well as residual solvents.Conclusions The quality of the cisatracurium besilate injection is good,and the current specifications should be further improved and unified.It was proposed that the infrared spectrum,related substance,and 1,5-pentanediol diacrylate method be added or revised,and the limit of endotoxin strictly controlled.It was proposed that manufacturers pay attention to the quality of API and control injection production.
